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 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 12:53 AM
NCT ID:
NCT02615067
Eligibility Criteria:
INCLUSION CRITERIA:
* Ability to provide informed consent and willingness to comply with protocol requirements
* Life expectancy ≥ 6 months
Cohort A only:
* A diagnostic trans-rectal ultrasound (TRUS)-guided biopsy within 12 months of enrollment showing adenocarcinoma of the prostate gland
* Within 90 days of consent, serum PSA ≤ 15.0 ng/mL or ≤ 7.5 ng/mL if on 5 α-reductase inhibitors.
* Candidates for active surveillance and/or a Gleason score ≤3+4
* Scheduled to undergo radical prostatectomy (RP) with or without pelvic lymph node dissection (PLND)
Cohort B only:
* Very low risk (VLR) prostate cancer defined by 2016 NCCN Guideline criteria:
* T1c stage, and
* PSA \< 10 ng/mL, and
* Gleason score ≤ 6 with \< 3 biopsy cores cancer positive and ≤ 50% cancer in any core based on prior prostate biopsy within 24 months of enrollment, and
* PSA density \< 0.15 mg/mL/g
* Scheduled to undergo a reassessment of prostate cancer staging that includes prostate biopsy as part of routine follow-up
EXCLUSION CRITERIA:
1. Subjects administered a radioisotope within 5 physical half-lives prior to study drug injection.
2. Previous treatment with hormonal therapy, surgery (except biopsy), radiation therapy, LHRH analogs, and non-steroidal anti-androgens, for the treatment of prostate cancer or benign prostatic hyperplasia (BPH)
3. Planned androgen or anti-androgen therapy prior to RP surgery or biopsy
4. Subjects with any medical condition or other circumstances that, in the opinion of the investigator, would significantly interfere with obtaining reliable data, achieving study objectives, or completing the study
5. Malignancy (not including curatively treated basal or squamous cell carcinoma of the skin) within the previous 5 years. (Ta stage transitional cell carcinoma bladder cancer with negative surveillance cystoscopy within the past 2 years may be included).
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02615067
Study Brief:
Protocol Section:
NCT02615067