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:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
NCT ID:
NCT03553212
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed prostate adenocarcinoma (a diagnostic biopsy with at least 10 cores is needed)
* Low and intermediate-risk NCCN risk categories: low-risk ( cT1-2a, Gleason Score ≤ 6 PSA \<10 ng/ml) and among those with intermediate-risk features (clinical stage T2b-c or GS 7 or PSA 10-20 ng/ml) those patients with favorable ones (a single factor for intermediate risk and GLS 3 + 4 and \<50% of biopsy cores containing cancer) will be selected. (30).
* Age ≥18 years
* Good performance status , Eastern Cooperative Oncology Group (ECOG) \< 2) or Karnofsky performance status (KPS) \> 70
* No previous pelvic RT
* Patient not eligible to prostatectomy or patient's refusal to undergo surgery.
* NO previous prostatectomy or TURP
* Good urinary flow (peak flow ≥ 10 ml/s)
* Previous ADT is permitted
* Prostate size ≤ 60 cc
* International Prostate Symptom Score ≤ 15
* Male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Nodal involvement or distant metastases (cN1 or cM1)
* Extracapsular tumor or locally advanced disease (cT3-cT4)
* IPSS questionnaire \> 20
* Concomitant inflammatory bowel
* Prior history of chronic prostatitis
* Prior history of urethral stricture
* Important systemic diseases or oral anticoagulant therapy ongoing
* Non-conformity to dose constraints at the treatment planning
* Other invasive cancer (apart from non-melanoma skin), unless the patient has been free from disease for at least 3 years;
* Abnormal complete blood count. Any of the following: platelet count less than 75,000/ml, Hb level less than 10 gm/dl, WBC less than 3.5/ml, abnormal renal function tests (creatinine \> 1.5), severe renal impairment (GFR less than 30)
* Placement of pacemakers and metallic vascular clips (all contraindication to performing prostate mpMRI).
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03553212
Study Brief:
Protocol Section:
NCT03553212