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 @ 6:54 PM
Ignite Modification Date:
2025-12-24 @ 6:54 PM
NCT ID:
NCT07291557
Eligibility Criteria:
Inclusion Criteria:
PSMA-N0M0 patients who have a documented history of High Risk localized adenocarcinoma of the prostate are eligible to participate if they meet the following eligibility criteria:
1. Participants capable of giving written informed consent.
2. Male.
3. Age ≥18 years.
4. ECOG ≤2.
5. Patient has histologically proven adenocarcinoma of prostate gland with an assigned Gleason score and Gleason Grade Group.
6. ≥NCCN High-Risk localized disease as per standard imaging investigations including pelvic imaging (CT, MRI) and 99Tc bone scan. High Risk prostate cancer defined as any of the following: cT3-T4 disease OR PSA ≥20 ng/ml OR Gleason grade group 4 or 5.
7. No documentation of regional nodal (N1) or metastatic (M1) prostate cancer on standard imaging (CT, MRI, or 99Tc bone scan).
8. In the opinion of the treating oncologist, patient is fit to undergo radical external beam radiotherapy to the prostate.
9. Patient commits to androgen suppression treatment as per standard of care. 10. Patient is willing to complete symptom and patient reported outcome questionnaires.
11\. Patients of childbearing / reproductive potential should use highly effective birth control methods, as defined by the investigator, during the study treatment period and for a period of 6 months after the last dose of radiation therapy. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly. Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard.
Male patients should agree to not donate sperm during the study and for 6 months after completion of radiation therapy.
Exclusion Criteria:
1. Inability to complete the investigational imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.).
2. Any additional medical condition, serious inter-current illness or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study performance, interpretation, or compliance with radiation
3. Patients who have initiated therapy (ADT, systemic therapy, or radiation) for their prostate cancer prior to PSMA-PET imaging.
4. History of inflammatory bowel disease, anal stenosis, colorectal surgery, or repeated endoscopic examinations/interventions related to anorectal diseases.
5. History of prostatectomy or previous pelvic radiotherapy.
6. Previous malignancy within the last five years, except BCC or SCC skin or a malignancy treated curatively with no evidence of disease for ≥5 years.
7. Bilateral hip prostheses will be ineligible for study
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT07291557
Study Brief:
Protocol Section:
NCT07291557