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.
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.
PSA ≥20 and/or
Gleason score ≥8 and/or
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.
Parallel
Brachytherapy
DrugAll patients will receive a single fraction of HDR-B (15Gy) 4-8 weeks prior to RALP. Patients with high genomic risk or node positivity will receive short course adjuvant AAB.
Incidence of Adverse Events
to assess the feasibility and safety of neoadjuvant HDR-B prior to RALP
Treatment Completion
to assess rate of treatment completion per protocol
Change From Baseline in International Prostate Symptom Score (IPSS)
Urinary health-related quality of life will be assessed using the International Prostate Symptom Score (IPSS). The IPSS questionnaire consists of 7 questions evaluating urinary symptoms. Total scores range from 0 to 35, with higher scores indicating more severe urinary symptoms. Change from baseline will be calculated at each follow-up time point.
Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC-26) Score
Health-related quality of life will be assessed using the Expanded Prostate Cancer Index Composite (EPIC-26), a validated questionnaire that evaluates urinary, bowel, sexual, and hormonal domains in patients with prostate cancer. Scores range from 0 to 100, with higher scores indicating better quality of life. Change from baseline will be calculated at each follow-up time point.
Change in Prostate-Specific Antigen (PSA)
Clinical response will be assessed by the change in serum prostate-specific antigen (PSA) levels from baseline to immediately prior to robot-assisted laparoscopic prostatectomy (RALP).
Radiologic Tumor Response on Multiparametric MRI (mpMRI)
Radiologic response will be evaluated using multiparametric MRI of the prostate performed at baseline and immediately prior to RALP to assess changes in tumor characteristics.
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