RECRUITING

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

Conditions

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

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-05-16

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06970847

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. At least 18 years of age. 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. 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.	1. Participants who received investigational agent within 5 biological half-lives prior to Day 1. 2. Participants administered any high energy (\>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1. 3. Previous systemic therapy for PC (with the exception of neoadjuvant and adjuvant systemic therapy as part of the definitive therapy). 4. 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. 5. Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components. 6. 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.

Inclusion Criteria

Exclusion Criteria

1. At least 18 years of age.
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.
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.

1. Participants who received investigational agent within 5 biological half-lives prior to Day 1.
2. Participants administered any high energy (\>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1.
3. Previous systemic therapy for PC (with the exception of neoadjuvant and adjuvant systemic therapy as part of the definitive therapy).
4. 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.
5. Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
6. 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.

Contacts and Locations

Study Contact

Clarity Pharmaceuticals Clarity Clinical Trials Contact

CONTACT

+61 (0) 2 9209 4037

clinicaltrials@claritypharmaceuticals.com

Study Locations (Sites)

XCancer

Omaha, Nebraska, 68130

United States

Collaborators and Investigators

Sponsor: Clarity Pharmaceuticals Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-16

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2025-05-16

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

Prostate Cancer
Prostate
Biochemical Recurrence

Additional Relevant MeSH Terms

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