64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants With Biochemical Recurrence of Prostate Cancer
NCT ID: NCT06970847
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
220 participants
INTERVENTIONAL
2025-05-16
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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64Cu-SAR-bisPSMA 200MBq 64Cu-SAR-bisPSMA.
64Cu-SAR-bisPSMA
All Patients will receive a single administration, a bolus injection of 200MBq 64Cu-SAR-bisPSMA
Interventions
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64Cu-SAR-bisPSMA
All Patients will receive a single administration, a bolus injection of 200MBq 64Cu-SAR-bisPSMA
Eligibility Criteria
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Inclusion Criteria
2. Signed informed consent.
3. Life expectancy ≥ 6 months as determined by the Investigator.
4. Histologically confirmed adenocarcinoma of prostate per original diagnosis and completed subsequent definitive therapy.
5. 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).
6. PSA level after definitive therapy:
1. 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
2. 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).
7. Participant willing to undergo biopsy of a 64Cu-SAR-bisPSMA PET-positive lesion for histological confirmation of PC, where this is safe and feasible.
8. An Eastern Cooperative Oncology performance status of 0-2.
Exclusion Criteria
2. Participants administered any high energy (\>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1.
3. Participants with known predominant small cell or neuroendocrine PC.
4. 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).
5. 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.
6. 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.
7. Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
8. 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.
18 Years
MALE
No
Sponsors
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Clarity Pharmaceuticals Ltd
INDUSTRY
Responsible Party
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Locations
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East Valley Urology Center of Arizona
Mesa, Arizona, United States
Arkansas Urology Research Center
Little Rock, Arkansas, United States
UC Irvine
Irvine, California, United States
Comprehensive Urology Medical Group
Los Angeles, California, United States
Alarcon Urology Center
Montebello, California, United States
University of Florida Health- Jacksonville
Jacksonville, Florida, United States
Biogenix Molecular
Miami, Florida, United States
Endeavor Health
Evanston, Illinois, United States
Indiana University Health-IU Simon Cancer Center
Indianapolis, Indiana, United States
Wichita Urology Group
Wichita, Kansas, United States
XCancer Research Network / LCMC Health EJGH
Metairie, Louisiana, United States
St. Louis University
St Louis, Missouri, United States
XCancer
Omaha, Nebraska, United States
New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico, United States
Albany Medical College
Albany, New York, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Urology Associates, P.C.
Nashville, Tennessee, United States
Urology Clinics of North Texas
Dallas, Texas, United States
Houston Metro Urology-SW
Houston, Texas, United States
The Urology Place
San Antonio, Texas, United States
Summit Urology
Murray, Utah, United States
Intermountain Medical Center
Salt Lake City, Utah, United States
St. Vincent's Hospital, Sydney
Darlinghurst, New South Wales, Australia
Sydney Adventist Hospital
Wahroonga, New South Wales, Australia
Westmead Private Hosptial
Westmead, New South Wales, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Countries
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Central Contacts
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Clarity Pharmaceuticals Clarity Clinical Trials Contact
Role: CONTACT
Facility Contacts
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Other Identifiers
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CLP10
Identifier Type: -
Identifier Source: org_study_id