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

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ClinicalTrials.gov Identifier: NCT04716725
Recruitment Status : Not yet recruiting
First Posted : January 20, 2021
Last Update Posted : May 28, 2021
Sponsor:
Collaborator:
Conquer Cancer Foundation
Information provided by (Responsible Party):
Rahul Aggarwal, University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
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 Drug: 68Ga-PSMA-11 Procedure: Positron Emission Tomography (PET) Phase 2

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 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase 2 Study of 68Ga-PSMA-11 PET in Patients With Metastatic Castration Resistant Prostate Cancer
Estimated Study Start Date : July 31, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Experimental (68Ga-PSMA-11 PET)
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
Given IV
Other Names:
  • 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

Procedure: Positron Emission Tomography (PET)
Undergo PET
Other Names:
  • PET
  • PET Scan




Primary Outcome Measures :
  1. Comparison between mean percent change in maximum standard uptake value (SUVmax) with Prostate-specific antigen (PSA) response group [ Time Frame: Baseline, and up to 16 weeks after initiation of therapy ]
    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 :
  1. Comparison of Change in SUVmax-ave Group on Progression Free Survival (PFS) [ Time Frame: Up to 24 months ]
    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 defined by PCWG3, radiographic progression-free defined by PCWG3

  2. Comparison of Change in SUVmax-ave Group on Overall Survival (OS) [ Time Frame: Up to 24 months ]
    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.

  3. Comparison between mean percent change in maximum standard uptake value (SUVmax) with objective response group [ Time Frame: Baseline, and up to 16 weeks after initiation of therapy ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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])

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04716725


Contacts
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Contact: Patricia Li 415-476-5975 GUTrials@ucsf.edu
Contact: Maya Aslam Maya.Aslam@ucsf.edu

Locations
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United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Contact: Patricia Li    415-476-5975    GUTrials@ucsf.edu   
Contact    877-827-3222    cancertrials@ucsf.edu   
Principal Investigator: Rahul R. Aggarwal, MD         
Sub-Investigator: Thomas Hope, MD         
Sponsors and Collaborators
University of California, San Francisco
Conquer Cancer Foundation
Investigators
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Principal Investigator: Rahul R Aggarwal, MD University of California, San Francisco
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Responsible Party: Rahul Aggarwal, Principal Investigator, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04716725    
Other Study ID Numbers: 209211
NCI-2020-13741 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: May 28, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Carcinoma
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases