NCT07182279
Neoadjuvant High Dose Rate Brachytherapy Prior to Radical Prostatectomy in Patients With Prostate Cancer
Recruiting · Phase 1, Phase 2 · The Methodist Hospital Research Institute · registry updated 2026-03-09
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
This is a Phase I/II trial evaluating the effectiveness of adding neoadjuvant HDR-B prior to RALP for HR-PCa patients with selective AAB for decipher high risk or pathologically node positive patients. Patients with newly diagnosed, histologically confirmed, non-metastatic, HR-PCa who are scheduled to receive RALP will be eligible to participate in the study.
Inclusion
- Subjects must have biopsy-confirmed adenocarcinoma of the prostate.
- Subjects must have a negative bone scan and CT scan or PSMA-PET for nodal or metastatic disease.
- Subjects must have one of the following risk factors:
- PSA ≥20 and/or
- Gleason score ≥8 and/or
- Clinical or radiographic stage ≥T3a per AJCC (American Joint Committee on Cancer) 8th Edition Staging Manual and/or
Exclusion
- Metastatic disease as demonstrated by bone scan, CT scan, MRI of the pelvis, or PSMA-PET.
- Declared high-risk for anesthesia by attending cardiologist, or other physician.
- History of prior pelvic radiation therapy.
- Prostate gland \>70 cc as assessed by MRI or TRUS.
- Baseline IPSS \>15 with medical optimization.
- History of androgen deprivation therapy within the past 6 months (except finasteride if discontinued \> 3 mo. prior to enrollment).