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 @ 3:28 PM
Ignite Modification Date:
2025-12-24 @ 3:28 PM
NCT ID:
NCT07115992
Eligibility Criteria:
Inclusion Criteria:
* Provided signed and dated informed consent form.
* Be male aged 18-80 years at consent.
* Commit to protocol compliance and complete all study procedures.
* Medically fit to tolerate interventions, including PSMA PET imaging, RARP, pelvic radiotherapy.
* Diagnosis of localized intermediate/high-risk prostate cancer (miN0M0):
i. Confirmed by: systematic biopsy + PSA + PSMA PET/MRI. ii. Briganti nomogram (2017)≥7%. iii. Candidate for radical prostatectomy. iv. D'Amico:
1. Intermediate-risk: PSA 10-20ng/mL OR Gleason 7 (ISUP Grade 2/3) OR cT2b;
2. High-risk: PSA\>20ng/mL OR Gleason\>7 (ISUP Grade 4/5) OR cT2c.
Exclusion Criteria:
* Prior treatments for prostate cancer, including radiotherapy, chemotherapy or endocrine therapy.
* Non-acinar adenocarcinoma histology on biopsy.
* Preoperative evidence of metastasis: nodal(N1), locally advanced(T3-4), or distant(M1) disease on imaging.
* History of pelvic lymphadenectomy or radiotherapy.
* Other malignancies within 5 years.
* Contraindications to radical prostatectomy or being deemed surgically inoperable upon clinical assessment.
* Contraindications to radiotherapy or intolerance determined by radiation oncologists.
* Severe allergy to PSMA PET ligands or excipients.
* Any other conditions precluding PSMA PET examination.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07115992
Study Brief:
Protocol Section:
NCT07115992