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 @ 10:54 PM
Ignite Modification Date:
2025-12-24 @ 10:54 PM
NCT ID:
NCT06171269
Eligibility Criteria:
Inclusion Criteria:
* Adult (≥ 18 years old) male patients with an ECOG Performance Status 0-2
* Histologically-confirmed, MRI-visible prostate adenocarcinoma with NCCN intermediate- or high-risk disease1 without extra-pelvic metastasis.
Exclusion Criteria:
* Distant metastases
* Prior active treatment for prostate cancer including radical prostatectomy, high-intensity focused ultrasound (HIFU), cryosurgery, ADT, or cytotoxic chemotherapy for treatment of prostate cancer. Patients with prostate cancer on active surveillance prior to the study are not excluded if they have not received active treatment.
* Prior pelvic radiotherapy including brachytherapy.
* Additional active concurrent malignancies (except localized cutaneous squamous or basal cell carcinomas).
* Comorbid conditions that, in the opinion of the treating radiation oncologist, preclude the patient from safely receiving the protocol-specified treatment including RT and/or ADT.
* Patients with contraindications to MRI including patients with ferromagnetic materials in their body (e.g. bioimplants, surgical hardware, shrapnel), patients who are unable to receive contrast due to history of allergy or impaired renal function (glomerular filtration rate \< 30 mil/min), and patients unable to tolerate MRI for other reasons (e.g. significant claustrophobia).
* Patients for whom hydrogel or hyaluronic acid spacer will be placed.
* Patients incapable of giving informed consent.
* Patients who are unable to adhere to the experimental protocols for any reason.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT06171269
Study Brief:
Protocol Section:
NCT06171269