RecruitingPhase 1/2

64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)

United States54 participantsStarted 2021-08-11

Plain-language summary

The aim of this study is to determine the safety and efficacy of 67Cu-SAR-bisPSMA in participants with PSMA-expressing metastatic castrate resistant prostate cancer.

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

. Serum/plasma prostate specific antigen (PSA) progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal value for study enrollment is 2.0 ng/mL;
. Soft-tissue progression defined as a ≥20% increase in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since the last treatment directed at the metastatic cancer has started (not including hormonal therapy) or the appearance of 1 or more new lesions;
. Progression of bone disease: evaluable disease or new bone lesions(s) by bone scan.

Exclusion criteria

. Participants with known hypersensitivity to enzalutamide or any of its ingredients.
. Participants with a history of seizures.
. Participants with a history of loss of consciousness (unless of cardiac origin) or transient ischemic attack within 12 months prior to enrolment into the study.
. Participants with conditions that increase the risk of seizures include those with a history of traumatic brain injury, stroke or cerebrovascular disease, arteriovenous malformations in the brain, neurodegenerative diseases, primary or metastatic brain tumors, active leptomeningeal disease, uncontrolled hypertension (systolic \>179 or diastolic \>105), patients undergoing alcohol withdrawal.

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

Biodistribution of 64Cu-SAR-bisPSMA

Timeframe: 48 hours

Dosimetry of 64Cu-SAR-bisPSMA

Timeframe: 48 hours

Modelling of 67Cu-SAR-bisPSMA dosimetry utilizing the 64Cu-SAR-bisPSMA PET/CT scans

Timeframe: 48 hours

Maximum Tolerated Dose (MTD) or Maximum Feasible Dose of a single dose of 67Cu-SAR-bisPSMA

Timeframe: 8 weeks

Recommended dose of two doses of 67Cu-SAR-bisPSMA

Timeframe: 14 weeks

Efficacy of 67Cu-SAR-bisPSMA in terms of Prostate specific Antigen (PSA) response

Timeframe: Up to 5 years

Efficacy of 67Cu-SAR-bisPSMA in terms of radiographic response

Timeframe: Up to 5 years

Trial details

NCT IDNCT04868604

SponsorClarity Pharmaceuticals Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09

Contact for this trial

Clarity Pharmaceuticals

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

View on ClinicalTrials.gov More Prostatic Neoplasms, Castration-Resistant trials

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

. Serum/plasma prostate specific antigen (PSA) progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal value for study enrollment is 2.0 ng/mL;
. Soft-tissue progression defined as a ≥20% increase in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since the last treatment directed at the metastatic cancer has started (not including hormonal therapy) or the appearance of 1 or more new lesions;
. Progression of bone disease: evaluable disease or new bone lesions(s) by bone scan.

Exclusion criteria

. Participants with known hypersensitivity to enzalutamide or any of its ingredients.
. Participants with a history of seizures.
. Participants with a history of loss of consciousness (unless of cardiac origin) or transient ischemic attack within 12 months prior to enrolment into the study.
. Participants with conditions that increase the risk of seizures include those with a history of traumatic brain injury, stroke or cerebrovascular disease, arteriovenous malformations in the brain, neurodegenerative diseases, primary or metastatic brain tumors, active leptomeningeal disease, uncontrolled hypertension (systolic \>179 or diastolic \>105), patients undergoing alcohol withdrawal.

What they're measuring

Biodistribution of 64Cu-SAR-bisPSMA

Timeframe: 48 hours

Dosimetry of 64Cu-SAR-bisPSMA

Timeframe: 48 hours

Modelling of 67Cu-SAR-bisPSMA dosimetry utilizing the 64Cu-SAR-bisPSMA PET/CT scans

Timeframe: 48 hours

Maximum Tolerated Dose (MTD) or Maximum Feasible Dose of a single dose of 67Cu-SAR-bisPSMA

Timeframe: 8 weeks

Recommended dose of two doses of 67Cu-SAR-bisPSMA

Timeframe: 14 weeks

Efficacy of 67Cu-SAR-bisPSMA in terms of Prostate specific Antigen (PSA) response

Timeframe: Up to 5 years

Efficacy of 67Cu-SAR-bisPSMA in terms of radiographic response

Timeframe: Up to 5 years