68Ga-PSMA-11 PET for the Diagnosis of Metastatic Castration Resistant Prostate Cancer

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: Male

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 medical intervention to block androgen production (castration resistant), and has spread to other places in the body (metastatic). 68Ga- PSMA-11 is a new imaging agent that may help get more detailed pictures of the tumor. This trial aims to see whether using 68Ga-PSMA-11 PET scans may help doctors learn more about where disease is located in the body.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: Conquer Cancer Foundation; Gateway for Cancer Research
• Treatments: Gallium 68 PSMA-11

Criteria

Inclusion Criteria:

• Participants progressive metastatic castration resistant prostate cancer, according to PCWG3 criteria

• Planned systemic treatment initiation for metastatic castration resistant prostate cancer following baseline Ga-PSMA PET

• The subject is 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

• Age 18 years or older at the time of study entry

• Participants who undergo optional metastatic tumor biopsy following completion of baseline Ga-PSMA PET must additionally meet 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 Criteria:

• Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent

• Any condition that, in the opinion of the principal investigator, would impair the patient's ability to comply with study procedures

• Contra- indication to MRI (e.g. pacemaker placement, severe claustrophobia) (applicable only for patients scheduled for PET/magnetic resonance imaging [MRI])