Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Rahul R Aggarwal, MD
Photo of Rahul R Aggarwal
Rahul R Aggarwal

Description

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.

Official Title

A Phase 2 Study of 68Ga-PSMA-11 PET in Patients With Metastatic Castration Resistant Prostate Cancer

Details

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 20 lesions per patient (SUVmax-average [ave]) is associated with >= 50% decline from baseline in serum prostate specific antigen (PSA50) response. SECONDARY OBJECTIVES: I. To determine whether the percent change from baseline in SUVmax-ave on PSMA PET is associated with time-to-event endpoints including PSA progression-free survival by Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria, radiographic progression-free survival by PCWG3 criteria, and overall survival. II. To determine whether the percent change from baseline in SUVmax on PSMA PET is associated with objective response by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 on a per-lesion basis among measurable soft tissue lesions present at baseline. EXPLORATORY (CORRELATIVE) OBJECTIVES: I. To descriptively characterize the histologic, transcriptional, and genomic features of PSMA low/negative lesions among patients who undergo paired optional metastatic tumor biopsy. II. To descriptively characterize the relationship between SUVmax-ave on baseline Ga-PSMA PET with optional baseline fludeoxyglucose F-18 (FDG)-PET. III. To determine whether heterogeneity of PSMA expression on baseline Ga-PSMA PET is associated with overall survival. IV. To descriptively characterize the patterns of PSMA expression at the time of disease progression among patients who undergo optional PSMA PET. V. To determine whether the percent change from baseline in PSMA PET is associated with PSA50 response among subgroups of patients defined by treatment modality received, including androgen receptor (AR) targeting treatment, PSMA-targeting radioligand therapy, cytotoxic chemotherapy, and immunotherapy. OUTLINE: Patients receive gallium Ga 68-PSMA-11 intravenously (IV) and undergo PET at baseline, 16 weeks after initiating therapy, and at time of disease progression. After progression or study completion, patients are followed up every 3 months for up to 24 months

Keywords

Castration-Resistant Prostate Carcinoma Metastatic Prostate Carcinoma Stage IV Prostate Cancer AJCC v8 Stage IVA Prostate Cancer AJCC v8 Stage IVB Prostate Cancer AJCC v8 Carcinoma Prostatic Neoplasms 68Ga-PSMA-11 Positron Emission Tomography (PET)

Eligibility

You can join if…

Open to males ages 18 years and up

  • 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

You CAN'T join if...

  • 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])

Location

  • University of California San Francisco
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Rahul R Aggarwal, MD
    I am a Medical Oncologist within the Division of Hematology/Oncology at the University of California San Francisco. My clinical practice focuses on patients with advanced solid tumor malignancies with a particular emphasis on genitourinary malignancies including prostate, kidney, bladder, and testicular cancer. I serve as the Co-Leader for the GU Medical Oncology program at UCSF.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04716725
Phase
Phase 2
Study Type
Interventional
Last Updated