Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT04839367
Eligibility 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 5 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.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT04839367
Study Brief:
Protocol Section:
NCT04839367