Clinical trial NCT05197257: 68Ga-PSMA-11 PET in Patients With Prostate Cancer
Official title: 68Ga-PSMA-11 PET in Patients With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Prostate Adenocarcinoma
Keywords: Newly Diagnosed
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 39
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Patients will receive a single dose of 68Ga-PSMA-11 and undergo a PET/CT or PET/MRI imaging study.

Detailed description: This is a prospective, Phase III, single-center, open-label to provide extended access in patients with biochemically recurrent prostate cancer. Approximately 100 patients are planned for enrollment in this study. Patients will receive a single dose of 68Ga-PSMA-11 and undergo a PET/CT or PET/MRI imaging study.

The intervention is a PET scan with the radiolabelled Prostate-specific membrane antifen (PSMA) ligand, 68Ga-PSMA-11. The PET may be combined with a CT scan as a PET/CT or an MRI scan as PET/MRI. 68Ga-PSMA-11 PET/CT will be acquired using a modern digital GE PET/CT scanner or a modern digital PET / MRI scanner.

AEs will be collected during injection and uptake phase (45-120 min posts infusion) of Ga-68 PSMA-11 PET/CT scan. All safety events will be recorded up to 120 min post injection.

Men with pathologically proven prostate adenocarcinoma, high risk cancer at diagnosis, evidence of biochemical recurrence, or known metastatic disease planned to start and change systemic therapy regimen.

One intravenous catheter will be placed for radiopharmaceutical administration. Patients will be injected with 100 MBq (3mCi)-300 MBq( 7mCi) of 68Ga-PSMA-11 via this catheter.

Eligibility criteria: Inclusion Criteria:

* Histopathologically proven prostate adenocarcinoma
* Age ≥ 18 years
* Patients already diagnosed with prostate cancer: Primary Staging: intermediate and high-risk patients per NCCN guidelines
* Biochemical Recurrence: Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy):

  a. Post radical prostatectomy (RP) - AUA recommendation i. PSA greater than or equal to 0.2 ng/mL measured more than 6-13 weeks after RP and confirmed by a second determination of a PSA level of \>0.2 ng/mL b. Post-radiation therapy - ASTRO-Phoenix consensus definition i. Nadir + greater than or equal to 2 ng/mL rise in PSA
* Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

* Unable to lie flat, still or tolerate a PET/CT scan, or any other condition that would preclude PET/CT imaging.
* Patients with any medical condition or circumstance that the investigator believes may compromise the data collection or lead to a failure to fulfil the study requirements.
* Patients with known hypersensitivity to the active substance or to any of the excipients of the investigational product.

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Immediately after administration and for 1 hour and 30 minutes afterwards
Secondary outcomes:
measure: Compare the Diagnostic Impact of 68Ga-PSMA-11 PET/CT Imaging Over Current Standard of Care Imaging Modalities.
timeFrame: 2 hours
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Colorado Research Center
state: Colorado
city: Denver
country: United States
facility: UCHealth-Metro Denver
state: Colorado
Study officials:
affiliation: Colorado Research Center
name: Bennett Chin
role: PRINCIPAL_INVESTIGATOR
References: