64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants With Biochemical Recurrence of Prostate Cancer

NCT06970847 | Recruiting Phase 3 FDA Drug

• 1 other identifier: CLP10
• Study Type: interventional
• Target: 220
• Locations: 2 countries
• Sites: 28

Brief Summary

The aim for this study is to investigate the ability of 64Cu-SAR-bisPSMA PET/CT to detect recurrence of prostate cancer

Conditions

Prostate Cancer Patients Who Have Brachytherapy Seed Implant; Prostate Cancer Patients Treated by Radiotherapy; Prostate Cancer; Prostate Cancer Recurrent; Cryotherapy; Prostate Cancer Patients With Detectable PSA Following Prostatectomy

Keywords

Prostate Cancer; Prostate; Biochemical Recurrence

Outcome Measures

Primary Outcomes (1)

• Ability of 64Cu-SAR-bisPSMA PET/CT to detect recurrence of prostate cancer

  Co-primary endpoints of participant-level CDR and region level PPV assessed independently for Day 1 and Day 2: * Participant-level CDR, defined as the proportion of TP participants scan out of all participants * Region-level PPV, defined as the proportion of TP regions out of all positive regions.

  Up to 52 Weeks

Secondary Outcomes (9)

• To investigate the safety and tolerability of 64-CuSAR-bisPSMA

  Up to 52 Weeks

• To assess the participants-level PPV of 64Cu-SAR-bisPSMA PET/CT

  Up to 52 Weeks

• To assess the participant-level DR of 64Cu-SAR-bisPSMA PET/CT

  Up to 52 Weeks

• To determine the efficacy of 64Cu-SAR-bisPSMA PET/CT in participants with negative or equivocal conventional imaging at baseline

  Up to 52 Weeks

• To determine the effect of the composition of Reference Standard on the performance of 64Cu-SAR-bisPSMA PET/CT

  Up to 52 Weeks

Study Arms (1)

64Cu-SAR-bisPSMA 200MBq 64Cu-SAR-bisPSMA.

EXPERIMENTAL

Drug: 64Cu-SAR-bisPSMA

Interventions

64Cu-SAR-bisPSMA DRUG

All Patients will receive a single administration, a bolus injection of 200MBq 64Cu-SAR-bisPSMA

64Cu-SAR-bisPSMA 200MBq 64Cu-SAR-bisPSMA.

Eligibility Criteria

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

You may qualify if:

• At least 18 years of age.
• Signed informed consent.
• Life expectancy ≥ 6 months as determined by the Investigator.
• Histologically confirmed adenocarcinoma of prostate per original diagnosis and completed subsequent definitive therapy.
• Participant potentially eligible for salvage therapy with curative intent (i.e. aligns with the definition of loco-regional therapy as described in protocol Section 7.2).
• PSA level after definitive therapy:
• Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL (per AUA recommendation) or
• Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir (per ASTRO-Phoenix consensus definition).
• Participant willing to undergo biopsy of a 64Cu-SAR-bisPSMA PET-positive lesion for histological confirmation of PC, where this is safe and feasible.
• An Eastern Cooperative Oncology performance status of 0-2.

You may not qualify if:

• Participants who received investigational agent within 5 biological half-lives prior to Day 1.
• Participants administered any high energy (\>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1.
• Participants with known predominant small cell or neuroendocrine PC.
• Previous systemic therapy for PC (with the exception of neoadjuvant and adjuvant systemic therapy as part of the definitive therapy and/or salvage therapy with radiation).
• Ongoing treatment or treatment within 6 months of Day 1 with any systemic therapy (e.g. any investigational therapy, androgen-deprivation therapy, antiandrogen, gonadotropin-releasing hormone, luteinizing hormone-releasing hormone agonist or antagonist, chemotherapy, immunotherapy or radiotherapy) for PC.
• Participants for whom there is an intent to initiate a prohibited medication(s)/treatment(s) (refer to Section 7.3) during the course of the participant's involvement in the study.
• Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
• Any serious medical condition or extenuating circumstance (including receiving the investigational product or not capable of having a PET scan) which the investigator feels may interfere with the procedures or evaluations of the study.

Sponsors & Collaborators

• Clarity Pharmaceuticals Ltd: lead

Study Sites (28)

East Valley Urology Center of Arizona

Mesa, Arizona, 85297, United States

WITHDRAWN

Arkansas Urology Research Center

Little Rock, Arkansas, 72211, United States

WITHDRAWN

UC Irvine

Irvine, California, 92697, United States

RECRUITING

Comprehensive Urology Medical Group

Los Angeles, California, 90048, United States

RECRUITING

Alarcon Urology Center

Montebello, California, 90640, United States

RECRUITING

University of Florida Health- Jacksonville

Jacksonville, Florida, 32209, United States

WITHDRAWN

Biogenix Molecular

Miami, Florida, 33165, United States

RECRUITING

Endeavor Health- Glenbrook Hospital

Glenview, Illinois, 60201, United States

RECRUITING

Indiana University Health-IU Simon Cancer Center

Indianapolis, Indiana, 46202, United States

RECRUITING

Wichita Urology Group

Wichita, Kansas, 67226, United States

RECRUITING

XCancer Research Network / LCMC Health EJGH

Metairie, Louisiana, 700006, United States

RECRUITING

M. Health Fairview University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

RECRUITING

St. Louis University

St Louis, Missouri, 63103, United States

RECRUITING

XCancer

Omaha, Nebraska, 68130, United States

RECRUITING

New Mexico Oncology Hematology Consultants

Albuquerque, New Mexico, 87109, United States

WITHDRAWN

Albany Medical College

Albany, New York, 12208, United States

RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15260, United States

RECRUITING

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

RECRUITING

Urology Associates, P.C.

Nashville, Tennessee, 37209, United States

RECRUITING

Urology Clinics of North Texas

Dallas, Texas, 75231, United States

NOT YET RECRUITING

Houston Metro Urology-SW

Houston, Texas, 77027, United States

WITHDRAWN

The Urology Place

San Antonio, Texas, 78240, United States

RECRUITING

Summit Urology

Murray, Utah, 84107, United States

NOT YET RECRUITING

Intermountain Medical Center

Salt Lake City, Utah, 84111, United States

RECRUITING

St. Vincent's Hospital, Sydney

Darlinghurst, New South Wales, 2010, Australia

ACTIVE NOT RECRUITING

Sydney Adventist Hospital

Wahroonga, New South Wales, 2076, Australia

RECRUITING

Westmead Private Hosptial

Westmead, New South Wales, 2145, Australia

RECRUITING

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Clarity Pharmaceuticals Clarity Clinical Trials Contact

CONTACT

+61 (0) 2 9209 4037; clinicaltrials@claritypharmaceuticals.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 14, 2025
• Study Start: May 16, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4); US (24)