Positron Emission Tomography (PET) Imaging of Participants With Confirmed Prostate Cancer Using 64Cu-SAR-bisPSMA (PROPELLER)

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

The aim of this study is to determine the safety and tolerability of 64Cu-SARbisPSMA in participants with untreated, confirmed Prostate Cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clarity Pharmaceuticals Ltd

Criteria

Inclusion Criteria:

• Signed informed consent;

• ≥18 years of age;

• Life expectancy >3 months;

• Confirmation of Prostate Cancer by histopathology and planned radical prostatectomy;

• Have ≥1 of the following intermediate- to high-risk features:

1. PSA level greater than or equal to 10.0 ng/ml within 12 weeks prior to enrolment;

2. International Society of Urological Pathology (ISUP) Grade Group 3 (i.e. Gleason score of 7 (4+3) or above;

3. Clinical stage greater than or equal to T2b;

• Participants must have adequate renal function;

• Sexually active participants who have female partners of childbearing potential:

Partner and/or participant must agree to use an acceptable form of contraception. Further participants must refrain from donating sperm;

• A 68Ga-PSMA-11 PET/CT scan performed within 4 weeks, but not closer than 6 hours prior to the administration of 64Cu-SAR-bisPSMA.

Exclusion Criteria:

• Prior prostatectomy or any other treatment for Prostate Cancer, including Androgen Deprivation Therapy and radiation therapy;

• Previous treatment with PSMA-targeted therapy within 3 months prior to enrolment, and administration of other investigational agents within 4 weeks prior to entering the study (except 68Ga-PSMA-11);

• Known hypersensitivity to the components of 64Cu-SAR-bisPSMA;

• Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated and who have been disease free for more than 3 years are eligible, as are participants with adequately treated non-melanoma skin cancer, superficial bladder cancer;

• Any serious medical condition which the Investigator feels may interfere with the procedures or evaluations of the study;

• Patients unwilling or unable to comply with protocol or with a history of noncompliance or inability to grant informed consent.