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 range18 Years

SexMALE

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

Incidence of 67Cu-SAR-bisPSMA Treatment-Emergent Adverse Events [Safety and Tolerability]

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 range18 Years

SexMALE

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

Incidence of 67Cu-SAR-bisPSMA Treatment-Emergent Adverse Events [Safety and Tolerability]

Timeframe: Up to 5 years