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

Status: Recruiting
Location: See all (27) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arkansas
Arkansas Urology Research Center
RECRUITING
Little Rock
Arizona
East Valley Urology Center of Arizona
RECRUITING
Mesa
California
UC Irvine
RECRUITING
Irvine
Comprehensive Urology Medical Group
RECRUITING
Los Angeles
Alarcon Urology Center
RECRUITING
Montebello
Florida
University of Florida Health- Jacksonville
RECRUITING
Jacksonville
Biogenix Molecular
RECRUITING
Miami
Illinois
Endeavor Health
RECRUITING
Evanston
Indiana
Indiana University Health-IU Simon Cancer Center
NOT_YET_RECRUITING
Indianapolis
Kansas
Wichita Urology Group
RECRUITING
Wichita
Louisiana
XCancer Research Network / LCMC Health EJGH
RECRUITING
Metairie
Missouri
St. Louis University
RECRUITING
St Louis
Nebraska
XCancer
RECRUITING
Omaha
New Mexico
New Mexico Oncology Hematology Consultants
NOT_YET_RECRUITING
Albuquerque
New York
Albany Medical College
RECRUITING
Albany
Pennsylvania
University of Pittsburgh Medical Center
NOT_YET_RECRUITING
Pittsburgh
South Carolina
Carolina Urologic Research Center
RECRUITING
Myrtle Beach
Tennessee
Urology Associates, P.C.
RECRUITING
Nashville
Texas
Urology Clinics of North Texas
NOT_YET_RECRUITING
Dallas
Houston Metro Urology-SW
RECRUITING
Houston
The Urology Place
RECRUITING
San Antonio
Utah
Summit Urology
NOT_YET_RECRUITING
Murray
Intermountain Medical Center
NOT_YET_RECRUITING
Salt Lake City
Other Locations
Australia
St. Vincent's Hospital, Sydney
ACTIVE_NOT_RECRUITING
Darlinghurst
Royal Brisbane and Women's Hospital
RECRUITING
Herston
Sydney Adventist Hospital
RECRUITING
Wahroonga
Westmead Private Hosptial
RECRUITING
Westmead
Contact Information
Primary
Clarity Pharmaceuticals Clarity Clinical Trials Contact
clinicaltrials@claritypharmaceuticals.com
+61 (0) 2 9209 4037
Time Frame
Start Date: 2025-05-16
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 220
Treatments
Experimental: 64Cu-SAR-bisPSMA 200MBq 64Cu-SAR-bisPSMA.
Related Therapeutic Areas
Sponsors
Leads: Clarity Pharmaceuticals Ltd

This content was sourced from clinicaltrials.gov