Clinical trial NCT05547386
Conditions: Castration-Resistant Prostate Carcinoma Metastatic Prostate Carcinoma Stage IVB Prostate Cancer AJCC v8
Sponsor: Mayo Clinic
Start date: 2022-05-09; Completion date: 2023-12-31
Enrollment: 163 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase III study provides access to 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) imaging for patients with castrate-resistant prostate cancer that has spread to other places in the body (metastatic) being considered for177Lu-PSMA-617 therapy. T PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of this tracer. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. Combining a PET scan with a CT scan can help make the images easier to interpret. The 68Ga-PSMA-11 PET/CT scan is done with a very small amount of radioactive tracer call 68- gallium PSMA-11. In patients that have been diagnosed with prostate cancer, a protein called prostate-specific membrane antigen (PSMA) appears in large amounts on the surface of the cancerous cells. The radioactive imaging agent (68Ga-PSMA-11) has been designed to circulate through the body and attach itself to the PSMA protein on prostate cancer cells. A PET/CT scan is then used to detect the location of prostate cancer lesions. By gaining access to 68Ga-PSMA-11 PET/CT scans, patients may be safely screened for 177Lu-PSMA-617 therapy in the treatment of metastatic castrate resistant prostate cancer.

Detailed description:
PRIMARY OBJECTIVE:

I. To overcome a clinical access issue that would otherwise block patients from reimbursement of a new cancer therapy, and therefore block or significantly delay their care.

OUTLINE:

Patients receive gallium Ga 68 gozetotide intravenously (IV) and then undergo a positron emission tomography (PET)/computed tomography (CT) scan throughout the trial.

Arms: arm 1: Patients receive 68Ga-PSMA-11 IV and then undergo a PSMA PET/CT scan throughout the trial.
Interventions: intervention 1: Computed Tomography intervention 2: Gallium Ga 68 Gozetotide intervention 3: Positron Emission Tomography
Intervention descriptions: intervention 1: Undergo PET/CT scan intervention 2: Given IV intervention 3: Undergo PET/CT scan

Protocol documents:
ICF_001.pdf: 
22-003732
68Ga-PSMA-11 PET/CT for Screening Prior to 177Lu-PSMA-617 
Therapy 
NCT05547386 
Document Date: 05/03/2023 


 
 
Approval Date:  
May 3, 2023 
Not to be used after: May 2, 2024 
 
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Name and Clinic Number 
 
RESEARCH PARTICIPANT CONSENT AND PRIVACY 
AUTHORIZATION FORM 
 
Study Title: 
68Ga-PSMA-11 PET/CT for Screening Prior to 177Lu-PSMA-617 Therapy  
 
IRB#:  
22-003732  
 
Principal Investigator: Dr. Geoffrey Johnson and Colleagues 
 
 
Key Study Information 
 
 
This section provides a brief summary of the study.  It is important for you to understand why 
the research is being done and what it will involve before you decide.  Please take the time to 
read the entire consent form carefully and talk to a member of the research team before 
making your decision.  You should not sign this form if you have any questions that have not 
been answered. 
It’s Your Choice 
This is a research study.  Being in this research study is your choice; 
you do not have to participate.  If you decide to join, you can still stop 
at any time.  You should only participate if you want to do so. You 
will not lose any services, benefits or rights you would normally have 
if you choose not to take part. 
Research Purpose 
The purpose of this research study is to provide access to 68Ga-PSMA-
11 PET/CT imaging.  
 
You have been asked to take part in this research because you are 
being considered for 177Lu-PSMA-617 treatment as part of your 
clinical care.  
What’s Involved 
Study participation involves one 68Ga-PSMA-11 PET/CT scan.   
 
You will be in the study until the completion of the 68Ga-PSMA-11 
PET/CT scan.   
Key Information 
There may not be a direct benefit to you by participating in this 
imaging study.  
 
If you take part in this research, you will have one 68Ga-PSMA-11 
PET/CT scan that involves exposure to radiation. The amount of 


 
 
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radiation from the 68Ga-PSMA-11 PET/CT scan has a low risk of 
harmful effects.  
 
The most common side effects of 68Ga-PSMA-11 were: 
• Nausea 
• Diarrhea 
• Dizziness 
 
The risks associated with study participation are completely described 
later in this form, be sure to review them carefully. 
 
This study will take approximately 2-3 hours to complete.  
 
As with all research, there is a chance that confidentiality could be 
compromised, however, we take precautions to minimize this risk and 
all other known risks.  
 
This study is being done to gather information and provide access to 
68Ga-PSMA-11 PET/CT.  You may choose not to take part in this 
study. 
Learn More 
If you are interested in learning more about this study, read the rest of 
this form carefully. The information in this form will help you decide 
if you want to participate in this research or not.  A member of our 
research team will talk with you about taking part in this study before 
you sign this form.  If you have questions at any time, please ask us.    
 
 
Making Your Decision 
 
 
Taking part in research is your decision.  Take your time to decide.  Feel free to discuss the study 
with your family, friends, and healthcare provider before you make your decision.  Taking part in 
this study is completely voluntary and you do not have to participate. 
 
If you decide to take part in this research study, you will sign this consent form to show that you 
want to take part. We will give you either a printed or electronic copy of this form to keep.  A 
copy of this form will be put in your medical record. 
 
For purposes of this form, Mayo Clinic refers to Mayo Clinic in Arizona, Florida and Rochester, 
Minnesota; Mayo Clinic Health System; and all owned and affiliated clinics, hospitals, and 
entities. 


 
 
Approval Date:  
May 3, 2023 
Not to be used after: May 2, 2024 
 
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Contact Information 
 
 
If you have questions about … 
You can contact … 
 Study tests and procedures 
 Materials you receive 
 Research-related appointments  
 Research-related concern or complaint 
 Research-related injuries or emergencies 
 Withdrawing from the research study 
Principal Investigator:  
Geoffrey Johnson, MD, PhD 
Phone: 507-284-4104 
 
Study Team Contact: Amber Stephan 
Phone: (507) 266-2927 
 
Institution Name and Address: 
Mayo Clinic 
200 First St SW 
Rochester MN 55905 
 Rights of a research participant 
Mayo Clinic Institutional Review Board (IRB)  
Phone: (507) 266-4000 
Toll-Free: (866) 273-4681 
 Rights of a research participant 
 Any research-related concern or complaint 
 Use of your Protected Health Information 
 Stopping your authorization to use your 
Protected Health Information 
 Withdrawing from the research study 
Research Participant Advocate (RPA) 
(The RPA is independent of the Study Team) 
Phone: (507) 266-9372 
Toll-Free: (866) 273-4681 
 
E-mail: researchparticipantadvocate@mayo.edu 
 Billing or insurance related to this research 
study 
Patient Account Services 
Toll-Free: (844) 217-9591  
 
Other Information: 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law. This Web site will not include information that can identify you. At most, the Web 
site will include a summary of the results. You can search this Web site at any time. 
 
 
 


 
 
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Why are you being asked to take part in this research study? 
 
 
You have been asked to take part in this research study because you are being considered for 
177Lu-PSMA-617 treatment as part of your clinical care.  
 
 
Why is this research study being done? 
 
 
The purpose of this research is to provide access to 68Ga-PSMA-11 PET/CT imaging for patients 
being considered for 177Lu-PSMA-617 treatment as part of their clinical care.  There may be up 
to 250 participants in this study.  
 
Combining a PET scan with a CT scan can help make the images easier to interpret. PET/CT 
scans are hybrid scanners that combine the two modalities into a single scan.  This allows images 
of both anatomy (CT) and function (PET) to be taken during the same examination. 
 
The 68Ga-PSMA-11 PET/CT scan is done with a very small amount of a radioactive tracer called 
68-Gallium PSMA-11. In patients that have been diagnosed with prostate cancer, a protein called 
prostate-specific membrane antigen (PSMA) appears in large amounts on the surface of the 
cancerous cells.  
 
The radioactive imaging agent (68Ga-PSMA-11) has been designed to circulate through the body 
and attach itself to the PSMA protein on prostate cancer cells. A PET/CT scan is then used to 
detect the location of prostate cancer lesions.  
 
The specific formulation/version of 68Ga-PSMA-11 used in this study is considered 
investigational, which means it either has not been approved by the FDA for routine clinical use 
or for the use described in this study. However, the FDA has allowed the use of this drug in this 
research study. We don’t know all the ways that this drug may affect people, but we hope the 
information from this study will help us develop a better imaging study to diagnosis prostate 
cancer in the future. 
 
 
 


 
 
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Information you should know 
 
 
Who is Funding the Study? 
Mayo Clinic is funding this study. 
 
Information Regarding Conflict of Interest: 
Your healthcare provider may be referring you to this research study.  If your healthcare provider 
is also an investigator on this study, there is the chance that his or her responsibilities for the 
study could influence his or her recommendation for your participation.  If you prefer, your 
healthcare provider will be happy to refer you to another investigator on the research study team 
for you to decide if you want to participate in the study and to see you for the research study 
activities while you are in the study. 
 
 
How long will you be in this research study? 
 
 
You will be in the study until the completion of the 68Ga-PSMA-11 PET/CT scan.   
 
 
What will happen to you while you are in this research study? 
 
 
The PET/CT scan will be done in the Charlton Building. This appointment will last 
approximately 2-3 hours, including reporting to the location where imaging will be performed 30 
minutes prior to the time you will receive an intravenous (IV) injection of 68Ga-PSMA-11, 60 
minutes of time to wait for 68Ga-PSMA-11 to go to sites where cancer may be hiding in your 
body, and 30 minutes for the scanning in the PET/CT scanner. You do not have fast for this 
appointment. 
 
You will be led to an uptake room where an intravenous catheter (IV) will be placed in a vein in 
your arm. This catheter will be used to inject 68Ga-PSMA-11, a radioactive imaging agent 
designed to specifically attach itself to the PSMA protein on prostate cancer cells. After the 
imaging agent is injected, you will be asked to sit and relax quietly for approximately 60 minutes 
to allow the drug to circulate in your body. 
 


 
 
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Next, a technologist will lead you to the PET/CT scanner. You will be positioned on the scanner 
bed on your back with your hands above your head or at your sides. The technologist will then 
begin the 30-minute PET/CT scan. During this scan, it is important to stay as still as possible. 
 
The scan report and images will be available in your medical record. 
 
After the PET/CT scan, you will continue on with your routine clinical care as advised by your 
treating physician. 
 
 
What are the possible risks or discomforts from being in this research study? 
 
 
If you take part in this research, you will have one 68Ga-PSMA-11 PET/CT scan that involve 
exposure to radiation. The amount of radiation from the 68Ga-PSMA-11 PET/CT scan has a low 
risk of harmful effects.  
 
The most common side effects of 68Ga-PSMA-11 are: 
• Nausea 
• Diarrhea 
• Dizziness 
 
As with any medication, allergic reactions are a possibility. The risk of an allergic reaction to 
68Ga-PSMA is minimal. As with any new or investigational drug, there may be adverse events or 
side effects that are currently unknown and it is possible that certain unknown risks could be 
permanent, serious, or life-threatening. 
 
The risks of intravenous (IV) line placement include pain, bruising, lightheadedness, and/or 
fainting, or rarely, infection at the site of the needle stick.  To minimize this risk, IV lines will be 
placed by experienced technologists. 
 
As with all research, there is a chance that confidentiality could be compromised, however, we 
take precautions to minimize this risk and all other known risks.  
 
 
Are there reasons you might leave this research study early? 
 
 
You may decide to stop at any time. You should tell the Principal Investigator if you decide to 
stop and you will be advised whether any additional tests may need to be done for your safety.  


 
 
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In addition, the Principal Investigator, the study sponsor, or Mayo Clinic may stop you from 
taking part in this study at any time: 
• if it is in your best interest,  
• if you don’t follow the study procedures,  
• if the study is stopped.  
 
If you leave this research study early, or are withdrawn from the study, no more information 
about you will be collected; however, information already collected about you in the study may 
continue to be used. 
 
New Information 
During the study new information about the imaging agents may become available. If this 
happens, your doctor will tell you about any new information that could affect your decision to 
continue participating in the study. You may be asked to sign an updated consent form that 
contains the new information. 
 
 
What if you are injured from your participation in this research study? 
 
 
Where to get help: 
If you think you have suffered a research-related injury, you should promptly notify the Principal 
Investigator listed in the Contact Information at the beginning of this form. Mayo Clinic will 
offer care for research-related injuries, including first aid, emergency treatment and follow-up 
care as needed. 
 
Who will pay for the treatment of research related injuries? 
Care for such research-related injuries will be billed in the ordinary manner, to you or your 
insurance. Treatment costs for research-related injuries not covered by your insurance will be 
paid by Mayo Clinic.  
 
 
What are the possible benefits from being in this research study? 
 
 
This imaging study may not make your health better.  However, having this scan may aid in 
meeting the criteria to be considered for 177Lu-PSMA-617 treatment as part of your routine 
clinical care.  
 
 


 
 
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May 3, 2023 
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What alternative do you have if you choose not to participate in this research 
study? 
 
 
This study is only being done to gather information.  You may choose not to take part in this 
study.  
 
 
What tests or procedures will you need to pay for if you take part in this research 
study? 
 
 
You won’t need to pay for tests and procedures which are done just for this research study.  
These tests and procedures are: 
• 
68Ga-PSMA-11 administration 
• 
68Ga-PSMA-11 PET/CT scan 
 
However, you and/or your insurance will need to pay for all other tests and procedures that you 
would have as part of your clinical care, including co-payments and deductibles. 
 
If you have billing or insurance questions call Patient Account Services at the telephone 
number provided in the Contact Information section of this form. 
 
 
Will you be paid for taking part in this research study? 
 
 
You won’t be paid for taking part in this study. 
 
 
Will your information or samples be used for future research? 
 
 
Identifiable information such as your name, Mayo Clinic number, or date of birth may be 
removed from your information collected in this study, allowing the information or samples to be 
used for future research or shared with other researchers without your additional informed 
consent. 
 


 
 
Approval Date:  
May 3, 2023 
Not to be used after: May 2, 2024 
 
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How will your privacy and the confidentiality of your records be protected? 
 
 
Mayo Clinic is committed to protecting the confidentiality of information obtained about you in 
connection with this research study. .In order to protect the confidentiality of your information, 
study data will be labeled with a unique identifying number (or “code”). Only the study staff at 
the site will have access to your personal information linking you to your study code, which will 
be stored in a secure location. If the results of the research are made public, information that 
identifies you will not be used. 
 
During this research, information about your health will be collected.  Under Federal law called 
the Privacy Rule, health information is private.  However, there are exceptions to this rule, and 
you should know who may be able to see, use and share your health information for research and 
why they may need to do so.  Information about you and your health cannot be used in this 
research study without your written permission.  If you sign this form, it will provide that 
permission (or “authorization”) to Mayo Clinic. 
 
Your health information may be collected from: 
• Past, present and future medical records. 
• Research procedures, including research office visits, tests, interviews and 
questionnaires. 
 
Your health information will be used and/or given to others to: 
• Do the research. 
• Report the results. 
• See if the research was conducted following the approved study plan, and applicable rules 
and regulations. 
 
Your health information may be used and shared with: 
• Mayo Clinic research staff involved in this study.  
• Other Mayo Clinic staff involved in your clinical care. 
• The sponsor(s) of this study and the people or groups hired by the sponsor(s) to help 
perform this research. 
• The Mayo Clinic Institutional Review Board that oversees the research.  
• Federal and State agencies (such as the Food and Drug Administration, the Department of 
Health and Human Services, the National Institutes of Health and other United States 
agencies) or government agencies in other countries that oversee or review research. 
• A group that oversees the data (study information) and safety of this research.  
 


 
 
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How your information may be shared with others: 
While taking part in this study, you will be assigned a code that is unique to you, but does not 
include information that directly identifies you. This code will be used if your study information 
is sent outside of Mayo Clinic. The groups or individuals who receive your coded information 
will use it only for the purposes described in this consent form. 
 
If the results of this study are made public (for example, through scientific meetings, reports or 
media), information that identifies you will not be used. 
 
In addition, individuals involved in study oversight and not employed by Mayo Clinic may be 
allowed to review your health information included in past, present, and future medical and/or 
research records. This review may be done on-site at Mayo Clinic or remotely (from an off-site 
location). These records contain information that directly identifies you. However, the 
individuals will not be allowed to record, print, or copy (using paper, digital, photographic or 
other methods), or remove your identifying information from Mayo Clinic. 
 
Is your health information protected after it has been shared with others? 
Mayo Clinic asks anyone who receives your health information from us to protect your privacy; 
however, once your information is shared outside Mayo Clinic, we cannot promise that it will 
remain private and it may no longer be protected by the Privacy Rule. 
 
 
Your Rights and Permissions 
 
 
Participation in this study is completely voluntary. You have the right not to participate at all.  
Even if you decide to be part of the study now, you may change your mind and stop at any time.  
You do not have to sign this form, but if you do not, you cannot take part in this research study. 
 
Deciding not to participate or choosing to leave the study will not result in any penalty.  Saying 
‘no’ will not harm your relationship with your own doctors or with Mayo Clinic. 
 
If you cancel your permission for Mayo Clinic to use or share your health information, your 
participation in this study will end and no more information about you will be collected; 
however, information already collected about you in the study may continue to be used. 
 
 
 


 
 
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May 3, 2023 
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You can cancel your permission for Mayo Clinic to use or share your health information at any 
time by sending a letter to the address below: 
 
Mayo Clinic 
Office for Human Research Protection 
ATTN:  Notice of Revocation of Authorization 
201 Building 4-60 
200 1st Street SW 
Rochester, MN  55905 
 
Alternatively, you may cancel your permission by emailing the Mayo Clinic Research 
Participant Advocate at:researchparticipantadvocate@mayo.edu. 
 
Please be sure to include in your letter or email: 
• The name of the Principal Investigator, 
• The study IRB number and /or study name, and 
• Your contact information. 
 
Your permission for Mayo Clinic to use and share your health information lasts until the end of 
this study, unless you cancel it.  The study does not end until all data has been collected, checked 
(or audited), analyzed, and reported. Because research is an ongoing process, we cannot give you 
an exact date when the study will end. Sometimes this can be years after your study visits and/or 
activities have ended. 
 
 


 
 
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{{$dteParticipantSig                                }} 
{{!$sigWitness}} 
{{$sigParticipant                    }} 
{{$prtPOCName                                       }} 
{{$dtePOCSig                                        }} 
{{$sigPOC                                 }} 
 
Enrollment and Permission Signatures 
 
 
Your signature documents your permission to take part in this research.  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
  
Printed Name  
 
 
Date (mm/dd/yyyy) 
 
 
Time (hh:mm am/pm)  
 
 
 
 
 
 
 
 
_______________________________ 
Signature 
 
 
 
Person Obtaining Consent  
• I have explained the research study to the participant. 
• I have answered all questions about this research study to the best of my ability. 
 
 
 
Printed Name  
 
 
Date (mm/dd/yyyy) 
 
 
Time (hh:mm am/pm) 
 
 
_______________________________ 
Signature 
 
 

Prot_000.pdf: 
 
 
 
 
 
22-003732 
 
 
68Ga-PSMA-11 PET/CT for Screening Prior to 177Lu-PSMA-617 
Therapy 
 
 
NCT05547386 
 
 
Document Date: 09/22/2022 


1 
Ga-PSMA-11 Pre-Therapy 
Version: 3 Date: 9/22/2022 
 
 68Ga-PSMA-11 PET/CT for Screening 
Prior to 177Lu-PSMA-617 Therapy 
 
Sponsor/Principal Investigator: Geoffrey Johnson, MD, PhD  
Mayo Clinic 
200 First Street SW 
Rochester MN 55905 
Co-Investigators: 
Eric Ehman, MD  
Mayo Clinic 
200 First Street SW 
Rochester MN 55905 
 
 
FDA IND #:151346 
 
Contents 
BACKGROUND: ............................................................................................................................................. 2 
Study Rationale ................................................................................................................................................. 2 
68Ga-PSMA-11 Administration ....................................................................................................................... 4 
68Ga-PSMA-11 PET/CT protocol .................................................................................................................... 5 
Patient selection for enrollment ........................................................................................................................ 5 
Study procedures ............................................................................................................................................... 6 
Radiation Dose Estimate for CT Component of PET/CT ................................................................................. 6 
Adverse Event (AE) Monitoring and Reporting ............................................................................................... 6 
Confidentiality .................................................................................................................................................. 8 
Source Documents ............................................................................................................................................ 9 
Records Retention ............................................................................................................................................. 9 
References ....................................................................................................................................................... 10 
 


2 
Ga-PSMA-11 Pre-Therapy 
Version: 3 Date: 9/22/2022 
 
Background:  
 
Below is the abstract from the Phase III VISION trial for 177Lu-PSMA-617 therapy for prostate 
cancer, which Mayo was involved in. This is the seminal trial that led to FDA approval of this new 
therapy. 
 
Metastatic castration-resistant prostate cancer remains fatal despite recent advances. Prostate-
specific membrane antigen (PSMA) is highly expressed in metastatic castration-resistant prostate 
cancer. Lutetium-177 ((177)Lu)-PSMA-617 is a radioligand therapy that delivers beta-particle 
radiation to PSMA-expressing cells and the surrounding microenvironment.  
 
METHODS: We conducted an international, open-label, phase 3 trial evaluating (177)Lu-PSMA-
617 in patients who had metastatic castration-resistant prostate cancer previously treated with at 
least one androgen-receptor-pathway inhibitor and one or two taxane regimens and who had 
PSMA-positive gallium-68 ((68)Ga)-labeled PSMA-11 positron-emission tomographic-computed 
tomographic scans. Patients were randomly assigned in a 2:1 ratio to receive either (177)Lu-
PSMA-617 (7.4 GBq every 6 weeks for four to six cycles) plus protocol-permitted standard care or 
standard care alone. Protocol-permitted standard care excluded chemotherapy, immunotherapy, 
radium-223 ((223)Ra), and investigational drugs. The alternate primary end points were imaging-
based progression-free survival and overall survival, which were powered for hazard ratios of 0.67 
and 0.73, respectively. Key secondary end points were objective response, disease control, and 
time to symptomatic skeletal events. Adverse events during treatment were those occurring no 
more than 30 days after the last dose and before subsequent anticancer treatment.  
 
RESULTS: From June 2018 to mid-October 2019, a total of 831 of 1179 screened patients 
underwent randomization. The baseline characteristics of the patients were balanced between the 
groups. The median follow-up was 20.9 months. (177)Lu-PSMA-617 plus standard care 
significantly prolonged, as compared with standard care, both imaging-based progression-free 
survival (median, 8.7 vs. 3.4 months; hazard ratio for progression or death, 0.40; 99.2% confidence 
interval [CI], 0.29 to 0.57; P<0.001) and overall survival (median, 15.3 vs. 11.3 months; hazard 
ratio for death, 0.62; 95% CI, 0.52 to 0.74; P<0.001). All the key secondary end points 
significantly favored (177)Lu-PSMA-617. The incidence of adverse events of grade 3 or above 
was higher with (177)Lu-PSMA-617 than without (52.7% vs. 38.0%), but quality of life was not 
adversely affected.  
 
CONCLUSIONS: Radioligand therapy with (177)Lu-PSMA-617 prolonged imaging-based 
progression-free survival and overall survival when added to standard care in patients with 
advanced PSMA-positive metastatic castration-resistant prostate cancer. (Funded by Endocyte, a 
Novartis company; VISION ClinicalTrials.gov number, NCT03511664.). 
 
Study Rationale 
 
This trial is designed to overcome a clinical access issue that would otherwise block patients 
from reimbursement of a new cancer therapy, and therefore block or significantly delay their 
care. 
 


3 
Ga-PSMA-11 Pre-Therapy 
Version: 3 Date: 9/22/2022 
 
On March 23, 2022, the FDA approved PSMA-targeted radionuclide therapy for the treatment 
of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic 
castration-resistant prostate cancer (mCRPC) who have been treated with an androgen receptor 
pathway inhibitor (ARPI) and taxane-based chemotherapy. PSMA-targeted radionuclide 
therapy is also known as 177Lu-PSMA-617, Lutetium Lu 177 Vipivotide Tetraxetan, and 
PluvictoTM.  
 
The FDA approval of PSMA-targeted radionuclide therapy was based on the phase III VISION 
trial (Sartor, de Bono et al. 2021). In the VISION trial, a specific form of PSMA-targeted PET 
radiotracer was used to evaluate if patients had PSMA-positive prostate cancer prior to PSMA-
targeted radionuclide therapy. The specific form of PSMA-targeted PET radiotracer used in the 
VISION trial was 68Ga-PSMA-11, also known as Gallium Ga 68 gozetotide. 68Ga-PSMA-11 
for the VISION trial was produced with a chemistry kit that was FDA approved on March 23, 
2022, now known as LocametzTM.  
 
The FDA approval of PSMA-targeted radionuclide therapy specifies to “select patients for 
treatment using Locametz® or an approved PSMA-11 imaging agent based on PSMA 
expression in tumors”. This FDA language was a surprise, as the medical community expected 
to be able to use any FDA approved PSMA-targeted PET radiotracer for patient selection for 
PSMA-targeted radionuclide therapy, and not be restricted to 68Ga-PSMA-11.  
 
Mayo and many other hospitals, imaging centers and clinical practices have an active PSMA-
targeted PET imaging practice using 18F-PSMA-DCFPyL PET radiotracer. 18F-PSMA-
DCFPyL was FDA approved on May 27, 2021. 18F-PSMA-DCFPyL is also known as, PyL, 
piflufolastat F 18, and PylarifyTM. 18F-PSMA-DCFPyL is more widely available than the more 
recently FDA-approved 68Ga-PSMA-11. Thus, most medical centers began a PSMA-targeted 
PET practice with 18F-PSMA-DCFPyL, and few have established access to 68Ga-PSMA-11.  
 
Most patients who have undergone PSMA-targeted PET scans (PET/CT or PET/MR) are likely 
to have received a 18F-PSMA-DCFPyL PET scan. However, the FDA-approval for PSMA-
targeted radionuclide therapy specifies that 68Ga-PSMA-11 PET be used prior to PSMA-
targeted radionuclide therapy.  
 
In order to obtain reimbursement for and open access to PSMA-targeted radionuclide therapy 
for appropriate Mayo patients suffering from prostate cancer this issue has to be resolved. 
While Mayo and others seek clarification from Medicare on this issue, many Mayo patients 
would be waiting and suffering. 
 
Therefore, we are establishing a protocol, by which we will allow for a limited number of 
appropriate patients to obtain a 68Ga-PSMA-11 PET/CT scan. The 68Ga-PSMA-11 PET/CT 
scan would be available even if the patient had a recent 18F-PSMA-DCFPyL PET scan 
(PET/CT or PET/MR). The 68Ga-PSMA-11 PET/CT scans will be performed at Mayo Clinic in 
Rochester at the expense of the Mayo Clinic Rochester Nuclear Medicine Division of the 
Department of Radiology. The radiotracer, scan, interpretation, study coordinator time and 
other related costs to run the protocol will be covered without expense to the patient. 
 
The 68Ga-PSMA-11 radiotracer will be produced at Mayo Clinic in Rochester under an active 
IND (IND 151346). This study has been submitted for FDA review as an extension under the 


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same IND. 
 
We recognize a patient may, as a result of this protocol, get two PSMA-targeted PET/CT exams 
within a short period of time. This will result in a small amount of additional radiation. 
However, without this scan and extra radiation, there could be a significant delay in access to 
cancer therapy, a therapy which may be life extending. It should be recognized that the PSMA-
targeted radionuclide therapy the patient is planning to undergo results in a significantly higher 
radiation exposure then the additional PSMA-targeted PET/CT scan included in this trial. 
 
We intend to make the 68Ga-PSMA-11 PET/CT imaging and interpretation of that imaging 
available in the electronic record for patients and their care team, so they can guide clinical care 
decisions. 
 
We anticipate referrals for 68Ga-PSMA-11 PET/CT under this protocol to come from Urology, 
Medical Oncology, Radiation Oncology, and Radiology. We anticipate performing up to six 
68Ga-PSMA-11 PET/CT scans per day. We anticipate this trial will run for up to 12 months. 
Therefore, the total population of patients we plan to scan with 68Ga-PSMA-11 PET/CT is not 
expected to exceed 250.  
 
It is possible we may need to extend this trial and increase the enrollment depending on the 
timing of the anticipated resolution of the Medicare and Insurance limitations on coverage 
described above. Alternatively, when our ability to produce an FDA approved version of 68Ga-
PSMA-11 allows us to convert our clinical practice away from 18F-PSMA-DCFPyL this 
protocol will no longer be needed. That practice conversion is currently under active 
development and is dependent in part on completion of construction of new PET radiochemistry 
facilities in Charlton North.   
 
Given that production of 68Ga-PSMA-11 is limited at our site, we may need to modulate access 
to patients in part depending on radiotracer and scanner availability. We also have limitations in 
terms of access to PET/CT. Thus, we will perform the majority of, or all of these 68Ga-PSMA-
11 PET/CT exams within the research facilities of the PET Imaging Resource on Charlton 6.  
 
Primary Endpoint: Safety 
 
Measurement: Monitoring of patients for self-reported unexpected adverse reactions from the 
time of injection until the time they leave the care of the Division of Nuclear Medicine. If any 
adverse reactions are reported, the patient will be evaluated by a nurse and/or physician and will 
receive appropriate care. The PI or those designated by the PI will ascertain the severity of the 
adverse event and how likely the adverse reaction was associated with the injected 68Ga-
PSMA-11.  
 
To date we have seen no adverse reactions to IV administered 68Ga-PSMA-11 at Mayo Clinic 
in Rochester and we have administered over 400 doses. 
 
68Ga-PSMA-11 Administration 
 


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The injected dose will be 185 MBq (5 mCi) (range 111-259 MBq; 3-7 mCi) of 68Ga-PSMA-
11. PET imaging will begin 50-100 minutes after injection. A use of existing Central/ PICC 
lines is considered acceptable for 68Ga-PSMA-11 administration. 
We may repeat a 68Ga-PSMA-11 injection and PET/CT in either of the following circumstances: 
- 
The patient had an unavoidable delay in care (such as a motor vehicle accident) and there 
is evidence or clinical concern that the patient’s cancer significantly progressed or 
responded to therapy in a way that could affect management of his cancer. 
- 
The patient still meets the criteria for enrollment in the study and 3 months of time or 
more has elapsed since the last 68Ga-PSMA-11 injection. 
 
68Ga-PSMA-11 PET/CT protocol 
 
The established 68Ga-PSMA-11 PET/CT imaging protocol will be followed. The scans will be 
performed on the Siemens VISION 600 PET/CT or GE DMI PET/CT on Charlton 6. The CT 
will be performed without IV or oral contrast and will follow standard clinical PET/CT protocol 
parameters. The exams will cover the orbits to thighs, unless otherwise specified by the 
Radiologist/Nuclear Medicine physician protocoling the specific exam for a given patient.  
 
Patient selection for enrollment 
 
Inclusion Criteria. All the following criteria must be met. 
- 
An adult male patient who… 
o is actively under the care of a Medical Oncology, Radiation Oncology or 
Urology physician at Mayo Clinic. 
o is deemed eligible (or potentially/likely eligible) for PSMA-targeted 
radionuclide therapy by a Nuclear Medicine Physician or Radiologist in the 
Nuclear Medicine therapy practice, or by the Prostate Theranostic Tumor Board 
(PTuB) 
 
eligibility will be documented in the medical record by the clinical 
practice 
 
it is acceptable for the patient to be eligible for PSMA-targeted 
radionuclide therapy in all regards except for having completed a 
PSMA-targeted PET scan showing PSMA-positive prostate cancer 
 
It is acceptable for a patient to be potentially eligible for therapy, but 
have a relative contraindication, such as a minor laboratory abnormality, 
and be on the list for discussion at the PTuB in the future 
o has not received a 68Ga-PSMA-11 PET/CT or PET/MR, or for whom a repeat 
68Ga-PSMA-11 PET/CT exam is needed per the clinical practice to ensure 
eligibility 
o does not otherwise have access to a reimbursable clinical 68Ga-PSMA-11 PET 
scan 
o An adult above the ages of 18 
 
Exclusion criteria. Any of the following. 
- 
A patient who is: 


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o unable to consent per Mayo guidelines 
o unable to lay still, or otherwise successfully complete the imaging exam 
 
Study procedures 
 
Patients who meet all inclusion and no exclusion criteria will be invited to participate in the study. 
The study coordinator will set up an appointment with the subject to discuss the study, answer any 
relevant questions, and obtain informed consent.  The study coordinator will schedule the 68Ga-
PSMA-11 PET/CT scan.  Patient’s participation in the study will end once their imaging visit is 
complete. The 68Ga-PSMA-11 PET/CT scans will be clinically interpreted with the report and 
imaging available in the patient’s medical record.  
 
Radiation Dose Estimate for CT Component of PET/CT 
The effective dose for a trunk CT (orbits to mid-thigh) is 6.3 mSv for males.  The effective 
dose for a 7 mCi IV injection of 68Ga-PSMA-11 is 4.4mSv. 
 
 
Adverse Event (AE) Monitoring and Reporting  
 
The site principal investigator is responsible for reporting any/all serious adverse events to the IRB 
and IND sponsor as described within the protocol, regardless of attribution to study agent or 
treatment procedure. 
 
The sponsor/sponsor-investigator is responsible for notifying FDA and all participating 
investigators in a written safety report of any suspected adverse reaction that is both serious and 
unexpected. 
 
Definitions:  
Adverse Event: Any untoward medical occurrence associated with the use of a drug in humans, 
whether or not considered drug related. 
 
Note: An adverse event (also referred to as an adverse experience) can be any unfavorable and 
unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated 
with the use of a drug, without any judgment about causality. An adverse event can arise from any 
use of the drug (e.g., off-label use, use in combination with another drug) and from any route of 
administration, formulation, or dose, including an overdose. 
  
Suspected Adverse Reaction: Any adverse event for which there is a reasonable possibility that the 
drug caused the adverse event. 
  
Note: For purposes of IND safety reporting, ‘‘reasonable possibility’’ means there is evidence to 
suggest a causal relationship between the drug and the adverse event. A suspected adverse reaction 
implies a lesser degree of certainty about causality than adverse reaction, defined below. 
  
Unexpected: An adverse event or suspected adverse reaction is considered ‘‘unexpected’’ if 


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• It is not listed in the investigator brochure or.  
• Is not listed at the specificity or severity that has been observed; or, 
• If an investigator brochure is not required or available, is not consistent with the risk 
information described in the general investigational plan (protocol) or elsewhere in the 
current IND application (as amended). 
  
Serious (previously SAE): An adverse event or suspected adverse reaction is considered ‘‘serious’’ 
if, in the view of either the investigator or sponsor, it results in any of the following outcomes: 
• Death, 
• A life-threatening adverse event, 
• Inpatient hospitalization or (Prolongation of existing hospitalization), or 
• A persistent or significant incapacity or substantial disruption of the ability to conduct 
normal life functions, or a congenital anomaly/birth defect. 
 
Note: Important medical events that may not result in death, be life-threatening, or require 
hospitalization may be considered serious when, based upon appropriate medical judgment, they 
may jeopardize the patient or subject and may require medical or surgical intervention to prevent 
one of the outcomes listed in this definition. 
 
Life-Threatening: An adverse event or suspected adverse reaction is considered ‘‘life-threatening’’ 
if, in the view of either the investigator or sponsor, its occurrence places the patient or subject at 
immediate risk of death. 
 
Note: It does not include an adverse event or suspected adverse reaction that, had it occurred in a 
more severe form, might have caused death. 
 
Attribution to agent or procedure: 
When assessing whether an adverse event (AE) is related to a medical agent(s) medical or 
procedure, the following attribution categories are utilized: 
Definite - The AE is clearly related to the agent(s)/procedure. 
Probable - The AE is likely related to the agent(s)/procedure. 
Possible - The AE may be related to the agent(s)/procedure. 
Unlikely - The AE is doubtfully related to the agent(s)/procedure. 
Unrelated - The AE is clearly NOT related to the agent(s)/procedure. 
 
FDA REPORTING REQUIREMENTS FOR SERIOUS ADVERSE EVENTS (21 CFR 
Part 312) 
NOTE: Investigators MUST immediately report to the sponsor ANY Serious Adverse Events, 
whether or not they are considered related to the investigational agent(s)/intervention (21 CFR 
312.64) 
An adverse event is considered serious if it results in ANY of the following outcomes:  
1) Death 
2) A life-threatening adverse event  
3) An adverse event that results in inpatient hospitalization or prolongation of existing 
hospitalization for ≥ 24 hours  
4) A persistent or significant incapacity or substantial disruption of the ability to conduct 
normal life functions  


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5) A congenital anomaly/birth defect.  
6) Important Medical Events (IME) that may not result in death, be life threatening, or 
require hospitalization may be considered serious when, based upon medical judgment, 
they may jeopardize the patient or subject and may require medical or surgical 
intervention to prevent one of the outcomes listed in this definition. (FDA, 21 CFR 
312.32; ICH E2A and ICH E6). 
ALL SERIOUS adverse events that meet the above criteria MUST be immediately reported to 
the sponsor within the timeframes detailed in the table below. 
Hospitalization 
Grade 1 
Timeframes 
Grade 2 
Timeframes 
Grade 3 
Timeframes 
Grade 4 & 5 
Timeframes 
Resulting in 
Hospitalization 
≥24 hrs 
7 Calendar Days 
24-Hour  
3 Calendar 
Days 
Not resulting in 
Hospitalization 
≥24 hrs 
Not required 
7 Calendar Days 
Expedited AE reporting timelines are defined as: 
o “24-Hour; 3 Calendar Days” - The AE must initially be reported within 24 hours of 
learning of the AE, followed by a complete expedited report within 3 calendar days 
of the initial 24-hour report. 
o “7 Calendar Days” - A complete expedited report on the AE must be submitted 
within 7 calendar days of learning of the AE. 
1Serious adverse events that occur more than 30 days after the last administration of 
investigational agent/intervention and have an attribution of possible, probable, or definite 
require reporting as follows:  
Expedited 24-hour notification followed by complete report within 3 calendar days for: 
• All Grade 4, and Grade 5 AEs 
Expedited 7 calendar day reports for: 
• Grade 2 adverse events resulting in hospitalization or prolongation of 
hospitalization  
• Grade 3 adverse events 
2 For studies using PET or SPECT IND agents, the AE reporting period is limited to 10 
radioactive half-lives, rounded UP to the nearest whole day, after the agent/intervention was 
last administered. Footnote “1” above applies after this reporting period. 
 
Confidentiality 
 
Information about study subjects will be kept confidential and managed according to the 
requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  Those 
regulations require a signed subject authorization informing the subject of the following: 


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• What protected health information (PHI) will be collected from subjects in this study 
• Who will have access to that information and why 
• Who will use or disclose that information 
• The rights of a research subject to revoke their authorization for use of their PHI. 
 
In the event that a subject revokes authorization to collect or use PHI, the investigator, by 
regulation, retains the ability to use all information collected prior to the revocation of subject 
authorization. 
 
Source Documents 
 
The Source data comprise all information, original records of clinical findings, observations, or 
other activities in a clinical treatment necessary for the reconstruction and evaluation of the 
treatment response.  Source data are contained in source documents.  Examples of these original 
documents, and data records include: hospital records, clinical and office charts, laboratory notes, 
radiological imaging data,  memoranda, subjects’ diaries or evaluation checklists, pharmacy 
dispensing records, recorded data from automated instruments, copies or transcriptions certified 
after verification as being accurate and complete, microfiches, photographic negatives, microfilm or 
magnetic media, subject files, and records kept at the pharmacy, at the laboratories, and at medico-
technical departments involved in the study. 
 
Records Retention 
 
The principal-investigator will maintain records and essential documents related to the conduct of 
the study.  These will include subject case histories and regulatory documents. The principal-
investigator will retain the specified records and reports as outlined in the Mayo Clinic Research 
Policy Manual –“Retention of and Access to Research Data Policy” 
http://mayocontent.mayo.edu/research-policy/MSS_669717 .


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References 
1. 
Sartor, O., et al. (2021). "Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate 
Cancer." N Engl J Med 385(12): 1091-1103.