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:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT07302451
Eligibility Criteria:
Inclusion Criteria:
* Male sex. (This criterion is required for the patient population being studied and for the correct data structuring in CTIS.)
* Age \> 18 years;
* Diagnosis of prostate cancer via transperineal core biopsy;
* Classified as unfavorable intermediate-risk (T2b-2c, PSA ≤ 20 ng/mL, and Gleason score 7(4+3); ISUP grade 3);
* Signed informed consent for REDI-CaP protocol;
* Signed consent for REDI-CaP data processing;
* Prostate volume \< 80 cc;
* No evidence of prostate capsule invasion (documented by multiparametric MRI of the prostate);
* Performance status: 0-1;
* Negative total-body CT with contrast and bone scan for metastases;
* Negative PSMA PET for secondary lesions;
* IIEF-5 score: \> 8;
* Patient compliance with completing periodic questionnaires and attending regular follow-ups as required by the study.
Exclusion Criteria:
* Have prostate cancer classified as low-risk, favorable intermediate-risk, or high-risk;
* Exhibit erectile dysfunction at baseline (IIEF-5 score: \< 8);
* Show positive PSMA PET results for metastases or pelvic lymph nodes;
* Have capsular involvement documented by multiparametric prostate MRI;
* Have contraindications to radiotherapy and/or hormone therapy;
* Are unable to undergo MRI;
* Cannot adhere to periodic tests and follow-ups;
* Refuse or have contraindications to the implantation of intraprostatic fiducials.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT07302451
Study Brief:
Protocol Section:
NCT07302451