search
Back to results

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

Primary Purpose

Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
68Ga-PSMA-11
Positron Emission Tomography (PET)
Sponsored by
Thomas Hope
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Castration-Resistant Prostate Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Sub-cohort A1: Patients must have baseline evaluations performed within 12 weeks prior to the start of systemic therapy.

  2. 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.

  3. Patients must have progressive castration resistant prostate cancer, according to PCWG3 criteria.
  4. 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.
  5. Patients must have at least one metastatic lesion with PSMA uptake at or above the blood pool on their baseline PSMA PET scan.
  6. The patient must be able and willing to comply with study procedures and provide signed and dated informed consent.
  7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  8. Patient must be Aged 18 years or older at the time of study entry.

  9. 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 Criteria:

  1. Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
  2. Patients with any condition that, in the opinion of the Principal Investigator, would impair the patient's ability to comply with study procedures.
  3. 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).

Sites / Locations

  • University of California San Francisco

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental (68Ga-PSMA-11 PET)

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
Comparison between mean percent change in SUVmax with Prostate-specific antigen (PSA) response group
The study cohort will be divided into subgroups based on whether or not patient experienced a >= 50% decline from baseline in serum PSA (PSA50 responder) or not (PSA50 non-responder). The mean percent change from baseline in SUVmax (SUVmax-ave) on PSMA PET between PSA50 responders vs. non-responders will be compared using the Mann-Whitney test.

Secondary Outcome Measures

Comparison of Change in SUVmax-ave Group on Progression Free Survival (PFS)
The study cohort will be dichotomized by the median with respect to percent change from baseline in SUVmax-ave on PSMA PET. The time-to-event variables including PSA progression-free will be defined by Prostate Cancer Clinical Trials Working Group 3 (PCWG3).
Comparison of Change in SUVmax-ave Group on Overall Survival (OS)
The study cohort will be dichotomized by the median with respect to percent change from baseline in SUVmax-ave on PSMA PET on overall survival defined as time from imaging until death or censored at study completion. OS will be compared between dichotomized subgroups using the log-rank test. Kaplan-Meier product limit method will be used to estimate median survival in each subgroup.
Comparison between mean percent change in SUVmax with objective response group
Amongst the subset of measurable soft tissue lesions by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, on a per-lesion basis, the mean percent change from baseline in SUVmax on PSMA PET will be compared between responding lesions defined as a complete response or partial response by RECIST 1.1 criteria vs. those without response, using Mann-Whitney test.

Full Information

First Posted
January 15, 2021
Last Updated
October 10, 2023
Sponsor
Thomas Hope
Collaborators
Conquer Cancer Foundation, Gateway for Cancer Research, Prostate Cancer Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT04716725
Brief Title
68Ga-PSMA-11 PET for the Diagnosis of Metastatic Castration Resistant Prostate Cancer
Official Title
A Phase 2 Study of 68Ga-PSMA-11 PET in Patients With Metastatic Castration Resistant Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 28, 2021 (Actual)
Primary Completion Date
August 30, 2023 (Actual)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Thomas Hope
Collaborators
Conquer Cancer Foundation, Gateway for Cancer Research, Prostate Cancer Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
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-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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental (68Ga-PSMA-11 PET)
Arm Type
Experimental
Arm Description
Patients receive gallium 68Ga-PSMA-11 IV and undergo PET at baseline, 16 weeks after initiating therapy, and at time of disease progression.
Intervention Type
Drug
Intervention Name(s)
68Ga-PSMA-11
Other Intervention Name(s)
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
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography (PET)
Other Intervention Name(s)
PET, PET Scan
Intervention Description
Undergo PET
Primary Outcome Measure Information:
Title
Mean maximum standard uptake value (SUVmax)
Description
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.
Time Frame
Baseline, and up to 16 weeks after initiation of therapy
Title
Median SUVmax
Description
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.
Time Frame
Baseline, and up to 16 weeks after initiation of therapy
Title
Comparison between mean percent change in SUVmax with Prostate-specific antigen (PSA) response group
Description
The study cohort will be divided into subgroups based on whether or not patient experienced a >= 50% decline from baseline in serum PSA (PSA50 responder) or not (PSA50 non-responder). The mean percent change from baseline in SUVmax (SUVmax-ave) on PSMA PET between PSA50 responders vs. non-responders will be compared using the Mann-Whitney test.
Time Frame
Baseline, and up to 16 weeks after initiation of therapy
Secondary Outcome Measure Information:
Title
Comparison of Change in SUVmax-ave Group on Progression Free Survival (PFS)
Description
The study cohort will be dichotomized by the median with respect to percent change from baseline in SUVmax-ave on PSMA PET. The time-to-event variables including PSA progression-free will be defined by Prostate Cancer Clinical Trials Working Group 3 (PCWG3).
Time Frame
Up to 24 months
Title
Comparison of Change in SUVmax-ave Group on Overall Survival (OS)
Description
The study cohort will be dichotomized by the median with respect to percent change from baseline in SUVmax-ave on PSMA PET on overall survival defined as time from imaging until death or censored at study completion. OS will be compared between dichotomized subgroups using the log-rank test. Kaplan-Meier product limit method will be used to estimate median survival in each subgroup.
Time Frame
Up to 24 months
Title
Comparison between mean percent change in SUVmax with objective response group
Description
Amongst the subset of measurable soft tissue lesions by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, on a per-lesion basis, the mean percent change from baseline in SUVmax on PSMA PET will be compared between responding lesions defined as a complete response or partial response by RECIST 1.1 criteria vs. those without response, using Mann-Whitney test.
Time Frame
Baseline, and up to 16 weeks after initiation of therapy

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivan A de Kouchovsky, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs