Status:
COMPLETED
68GA-PSMA-11 PET/CT Scan in Impacting Treatment Strategies for Patients With Prostate Cancer
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Conditions:
Biochemically Recurrent Prostate Carcinoma
Metastatic Prostate Carcinoma
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial studies the impact of 68GA-PSMA-11 positron emission tomography (PET)/computed tomography (CT) scan on treatment strategies for patients with prostate cancer. Diagnostic imaging pr...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the impact of gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) PET/CT on initial and subsequent treatment strategies of patients with prostate cancer. OUTLINE: Patie...
Eligibility Criteria
Inclusion
- Patients who fulfill criteria for initial staging or restaging as outlined below:
- Initial treatment strategy decisions (initial staging): All patients with histologically proven prostate cancer or strong suspicion of prostate adenocarcinoma based on very high prostate-specific antigen (PSA) levels (\> 50 ng/mL) who require an initial treatment/management decision who may be candidate for any of the following strategies:
- Surgery
- External radiation therapy (RT)
- Other focal therapies
- Systemic medical treatment
- Watchful waiting
- Assessment for subsequent treatment strategy (restaging), any of the following:
- Patients with biochemical recurrence who are potential candidates for any salvage treatment. Biochemical recurrence is defined by rising PSA after definitive therapy with prostatectomy or radiation therapy, as any of the following:
- Post radical prostatectomy (RP): PSA equals to or greater than 0.2 ng/mL measured more than 6 weeks after RP
- Post-radiation therapy: Nadir + greater than or equal to 2 ng/mL rise in PSA
- Patients with known prostate cancer who undergo restaging because of new symptoms
- Patients with known metastatic prostate cancer who undergo restaging because of rising PSA with negative or inconclusive conventional imaging
- Patients with known prostate cancer who are treated medically or with radioligand therapy (RLT) in whom response to treatment is assessed
- Note: Patients may be reenrolled in the study, if 68Ga-PSMA PET/CT is performed for subsequent management decision
- Capability to provide written informed consent
- Able to remain still for duration of each imaging procedure (about 30 minutes)
Exclusion
- Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
- Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
- Inability to provide written informed consent
Key Trial Info
Start Date :
April 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2021
Estimated Enrollment :
937 Patients enrolled
Trial Details
Trial ID
NCT04050215
Start Date
April 2 2018
End Date
September 27 2021
Last Update
September 30 2021
Active Locations (1)
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1
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095