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 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT04861194
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years
* Histologically proven adenocarcinoma of the prostate
* Low-risk or intermediate-risk prostate cancer according to NCCN risk categories (low risk: T1c-T2a, Gleason score ≤6, and PSA \<10 µg/L; intermediate risk: T2b-T2c or Gleason score 7 or PSA 10-20 µg/L)
* Patients with pT1a/b tumor diagnosis after transurethral resection of the prostate (TURP)
* Domain score of 17-25 on the International Index of Erectile Function-5 (IIEF-5) questionnaire
* Karnofsky score of 70-100
* Written informed consent
Exclusion Criteria:
* Use of (neo-)adjuvant androgen deprivation therapy
* High-risk prostate cancer according to NCCN risk categories (T3a or Gleason score 8-10 or PSA \>20 µg/L)
* Patients with "bulky" iT3 tumor diagnosis
* Previous pelvic irradiation or radical prostatectomy
* Clinical evidence of metastatic disease
* Patients who are unable to undergo MRI
* Patients who are incompetent to sign written informed consent
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT04861194
Study Brief:
Protocol Section:
NCT04861194