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:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07393867
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age and older.
* Eastern Oncology Group Status 0 to 1.
* Histologic diagnosis of prostate cancer.
* Prior screening MRI with at least one PI-RADS4 or PI-RADS 5 lesion, obtained within 180 days of screening.
* NCCN intermediate-risk or high-risk prostate cancer (Appendix B). All patients will be staged by MRI.
* Prior PSMA PET scan with at least one focal avid lesion greater than background prostate that is concordant with a lesion on MRI, obtained within 180 days of screening.
* Intention for SBRT (36.25 Gy/5 fraction) with focal boost (up to 50 Gy) to one MRI/PET-concordant lesion34.
Exclusion Criteria:
* Prior imaging (CT, bone scan, MRI, PSMA-PET/CT) showing nodal or distant disease.
* Intention to receive treatment intensification with secondary androgen receptor signaling inhibitors or chemotherapy.
* Clinical T4 disease.
* Prior ADT.
* Prior pelvic RT.
* Prior prostate surgery, including TURP.
* International prostate symptom score \> 20.
* Prior urethral stricture.
* Prostate volume \> 80 cc on MRI.
* Hip implants that cause artifacts over the prostate gland.
* Inability to discontinue anti-coagulation for fiducial marker placement.
* Active Crohn's disease or scleroderma.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT07393867
Study Brief:
Protocol Section:
NCT07393867