Clinical trial NCT02673151: 68Ga-PSMA PET/CT in Detecting Prostate Cancer Recurrence in Patients With Elevated PSA After Initial Treatment
Official title: 68-Ga PSMA 11 PET/CT for Detection of Recurrent Prostate Cancer After Initial Therapy in Patients With Elevated PSA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Prostate Adenocarcinoma
PSA Failure
Recurrent Prostate Carcinoma
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2016-02-03
Enrollment: 61
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this research study is to see if recurrent prostate cancer can be identified using a special procedure called a positron emission tomography (PET) scan. PET/CT is used to describe information regarding the function, as well as location and size of a tumor.

Detailed description: PRIMARY OBJECTIVES:

I. To evaluate 68Ga-PSMA-11 PET/CT for detection of recurrent prostate cancer after initial therapy in patients with elevated PSA. PSMA refers to prostate-specific membrane antigen.

Eligible participants will undergo baseline assessments at enrollment. Study participants will receive 68Ga-PSMA-11 and undergo a PET/CT. Participants will be contacted at 24 to 72 hours following the scan in order to capture potential late occurring adverse events. Clinical follow up of participant at 3 to 12 months following the scan in order to analyze secondary endpoints.

Eligibility criteria: Inclusion Criteria:

* Histopathological proven prostate adenocarcinoma
* Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy)

  * Post radical prostatectomy (RP) - American Urology Association (AUA) recommendation

    * PSA greater than 0.2 ng/mL measured 6 to 13 weeks after RP
    * Confirmatory persistent PSA greater than 0.2 ng/mL (total of two PSA measurements greater than 0.2 ng/mL)
  * Post-radiation therapy -American Society for Radiation Oncology (ASTRO)-Phoenix consensus definition

    * A rise of PSA measurement of 2 or more ng/mL over the nadir
* Karnofsky performance status of ≥ 50 (or Eastern Cooperative Oncology Group \[ECOG\] / World Health Organization \[WHO\] equivalent)
* Able to provide written consent

Exclusion Criteria:

* Investigational therapy for prostate cancer.
* Unable to lie flat, still or tolerate a positron emission tomograpy (PET) scan.
* Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.

Primary outcomes:
measure: Confirmation of Prostate Cancer Recurrence by 68Ga-PSMA-11 PET/CT
timeFrame: up to 12 months
Secondary outcomes:
measure: 68Ga-PSMA-11 PET/CT Sensitivity and Specificity
timeFrame: up to 12 months
measure: 68Ga-PSMA-11 PET/CT Predictive Value by Region
timeFrame: up to 12 months
measure: Overall 68Ga-PSMA-11 PET/CT Scan Quality Stratified by PSA Level
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University, School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Andrei Iagaru, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baratto L, Song H, Duan H, Hatami N, Bagshaw HP, Buyyounouski M, Hancock S, Shah S, Srinivas S, Swift P, Moradi F, Davidzon G, Iagaru A. PSMA- and GRPR-Targeted PET: Results from 50 Patients with Biochemically Recurrent Prostate Cancer. J Nucl Med. 2021 Nov;62(11):1545-1549. doi: 10.2967/jnumed.120.259630. Epub 2021 Mar 5.