Status:
ACTIVE_NOT_RECRUITING
68Ga-PSMA-11 PET for the Diagnosis of Metastatic Castration Resistant Prostate Cancer
Lead Sponsor:
Thomas Hope
Collaborating Sponsors:
Conquer Cancer Foundation
Gateway for Cancer Research
Conditions:
Castration-Resistant Prostate Carcinoma
Metastatic Prostate Carcinoma
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial studies the use of 68Ga-PSMA-11 positron emission tomography (PET) in diagnosing patients with prostate cancer that continues to grow despite the surgical removal of the testes or ...
Detailed Description
PRIMARY OBJECTIVE: I. To determine whether the percent change from baseline to 16 weeks (+/- 8 weeks) in maximum standard uptake value (SUVmax) averaged across up to 16 lesions per patient (SUVmax-av...
Eligibility Criteria
Inclusion
- Sub-cohort A1: Patients must have baseline evaluations performed within 12 weeks prior to the start of systemic therapy.
- Sub-cohort A2: Patients must meet all the following requirements:
- Have had a baseline pre-treatment 68Ga-PSMA-11 PET scan and PSA measurement performed within 12 weeks prior to the start of current systemic therapy.
- Able to have an on-treatment 68Ga-PSMA-11 PET and a PSA measurement within 16 weeks (+/- 8 weeks) after the start of current systemic therapy.
- Note: The screening period for sub-cohort A2 is within 24 weeks after the patient started their current systemic therapy.
- Patients must have progressive castration resistant prostate cancer, according to PCWG3 criteria.
- Patients must have planned initiation of systemic treatment (sub-cohort A1), or ongoing systemic treatment (sub-cohort A2) for castration resistant prostate cancer within 12 weeks of baseline Ga-PSMA PET.
- Patients must have at least one metastatic lesion with PSMA uptake at or above the blood pool on their baseline PSMA PET scan.
- The patient must be able and willing to comply with study procedures and provide signed and dated informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Patient must be Aged 18 years or older at the time of study entry.
- Patients who undergo optional metastatic tumor biopsy following completion of baseline Ga-PSMA PET must additionally meet all of the following criteria:
- Presence of one or more metastases by standard radiographic scans that is safely accessible to tumor biopsy in the judgment of treating clinician and/or Interventional Radiology.
- No history of radiation therapy to the target metastatic lesion selected for tumor biopsy.
- No contra-indication to biopsy including uncontrolled bleeding diathesis.
- Platelets \> 75,000/ul and prothrombin time (PT) or institution normalized ratio (INR) and a partial thromboplastin time (PTT) \< 1.5 times the institutional upper limit of normal (ULN) within 14 days prior to biopsy.
Exclusion
- Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
- Patients with any condition that, in the opinion of the Principal Investigator, would impair the patient's ability to comply with study procedures.
- Patients with any contra-indication to magnetic resonance imaging (MRI) (e.g. pacemaker placement, severe claustrophobia) Note: The exclusion criteria above (3) is only applicable for patients scheduled for a Positron Emission Tomography (PET) MRI (PET/MRI).
Key Trial Info
Start Date :
September 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04716725
Start Date
September 28 2021
End Date
April 30 2025
Last Update
October 16 2024
Active Locations (1)
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1
University of California San Francisco
San Francisco, California, United States, 94143