CompletedPhase 2

64Cu-SAR-BBN for Identification of Participants With Recurrence of Prostate Cancer (SABRE)

United States53 participantsStarted 2022-09-19

Plain-language summary

The aim of this study is to determine the safety and efficacy of 64Cu-SAR-BBN and determine the ability of 64Cu-SAR-BBN Positron emission tomography (PET)/computed tomography (CT) to correctly detect the recurrence of prostate cancer in participants with prostate-specific membrane antigen (PSMA)-negative biochemical recurrence of prostate cancer following definitive therapy.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. At least 18 years of age.
. Signed informed consent.
. Life expectancy ≥ 12 weeks as determined by the Investigator.
. Histologically confirmed adenocarcinoma of prostate per original diagnosis and completed subsequent definitive therapy.
. Suspected recurrence of PC based on rising PSA after definitive therapy on the basis of:
. Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL (per American Urological Association recommendation) or
. Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir (per American Society for Therapeutic Radiology and Oncology-Phoenix consensus definition).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety and Tolerability

Timeframe: Up to 7 days post injection

Participant-level Correct Detection Rate (CDR) - Day 0

Timeframe: Day 0 (1-4 hours) post injection

Participant-level CDR - Day 1.

Timeframe: Day 1 (24+/-6 Hours) post injection

Region-level Positive Predictive Value (PPV) - Day 0.

Timeframe: Day 0 (1-4 hours) post injection

Region-level PPV - Day 1.

Timeframe: Day 1 (24 +/- 6 hours) post injection

Trial details

NCT IDNCT05407311

SponsorClarity Pharmaceuticals Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-05-13

Results submitted2025-08-13

View on ClinicalTrials.gov More Biochemical Recurrence of Malignant Neoplasm of Prostate trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. At least 18 years of age.
. Signed informed consent.
. Life expectancy ≥ 12 weeks as determined by the Investigator.
. Histologically confirmed adenocarcinoma of prostate per original diagnosis and completed subsequent definitive therapy.
. Suspected recurrence of PC based on rising PSA after definitive therapy on the basis of:
. Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL (per American Urological Association recommendation) or
. Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir (per American Society for Therapeutic Radiology and Oncology-Phoenix consensus definition).

What they're measuring

Safety and Tolerability

Timeframe: Up to 7 days post injection

Participant-level Correct Detection Rate (CDR) - Day 0

Timeframe: Day 0 (1-4 hours) post injection

Participant-level CDR - Day 1.

Timeframe: Day 1 (24+/-6 Hours) post injection

Region-level Positive Predictive Value (PPV) - Day 0.

Timeframe: Day 0 (1-4 hours) post injection

Region-level PPV - Day 1.

Timeframe: Day 1 (24 +/- 6 hours) post injection

64Cu-SAR-BBN for Identification of Participants With Recurrence of Prostate Cancer (SABRE)

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

64Cu-SAR-BBN for Identification of Participants With Recurrence of Prostate Cancer (SABRE)

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria