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

NCT04716725 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 2 other identifiers: 209211NCI-2020-13741
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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 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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Mean Maximum Standard Uptake Value (SUVmax)

  The mean SUVmax and standard deviation across the primary tumor and the 5 largest lesions in each of three metastatic sites (nodal, visceral and osseous; for a maximum of 16 lesions per patient) will be descriptively reported.

  Baseline, and up to 16 weeks after initiation of therapy

• Median SUVmax

  The median and range of SUVmax across the primary tumor and the 5 largest lesions in each of three metastatic sites (nodal, visceral and osseous; for a maximum of 16 lesions per patient) will be descriptively reported.

  Baseline, and up to 16 weeks after initiation of therapy

• Percentage of Participants Who Progressed by Prostate-specific Antigen (PSA) Response Group

  The percent of participants who fall into the PSA50 responders vs. non-responders based on PSMA treatment response criteria (PPP) for progression status will be reported. PPP uses 3 different criteria to determine response: 1) Appearance of 2 or more new PSMA positive distant lesions, 2) Appearance of 1 new PSMA positive lesion plus consistent clinical and/or laboratory data and recommended confirmation by biopsy or correlative imaging within 3 months of PSMA PET, and 3) Increase in size or PSMA uptake of 1 or more existing lesions by 30% plus consistent clinical and/or laboratory data and/or confirmation by biopsy or correlative imaging within 3 months of PSMA PET.

  Baseline, and up to 16 weeks after initiation of therapy

Secondary Outcomes (3)

• Comparison of Change in SUVmax-ave Group on Progression Free Survival (PFS)

  Up to 24 months

• Comparison of Change in SUVmax-ave Group on Overall Survival (OS)

  Up to 24 months

• Comparison Between Mean Percent Change in SUVmax With Objective Response Group

  Baseline, and up to 16 weeks after initiation of therapy

Study Arms (1)

Experimental (68Ga-PSMA-11 PET)

EXPERIMENTAL

Patients receive gallium 68Ga-PSMA-11 IV and undergo PET at baseline, 16 weeks after initiating therapy, and at time of disease progression.

Drug: 68Ga-PSMA-11; Procedure: Positron Emission Tomography (PET)

Interventions

68Ga-PSMA-11 DRUG

Given IV

Also known as: 68Ga Prostate-specific Membrane Antigen (PSMA) 11, Gallium Ga-68 gozetotide, Gallium-68 PSMA, Gallium Ga 68 PSMA-11, Gallium Ga 68-labeled PSMA-11

Experimental (68Ga-PSMA-11 PET)

Positron Emission Tomography (PET) PROCEDURE

Undergo PET

Also known as: PET, PET Scan

Experimental (68Ga-PSMA-11 PET)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thomas Hope: lead
• Conquer Cancer Foundation: collaborator
• Gateway for Cancer Research: collaborator
• Prostate Cancer Foundation: collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gallium 68 PSMA-11; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Limitations and Caveats

Participant enrollment closed earlier than anticipated due to slow accrual

Results Point of Contact

• Title: Dr. Ivan de Kouchkovsky, MD
• Organization: University of California, San Francisco

ivan.dekouchkovsky@ucsf.edu

(415) 221-4810

Study Officials

• Ivan A de Kouchovsky, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Principal Investigator (IND Holder)

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 20, 2021
• Study Start: September 28, 2021
• Primary Completion: September 30, 2023
• Study Completion: April 30, 2025
• Last Updated: October 16, 2024
• Results First Posted: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)