High Dose Rate Brachytherapy Prior to Robotic Assisted Laparoscopic Prostatectomy With Selective Adjuvant Androgen Blockade for Localized High-risk Prostate Cancer (NEOHDR-B)
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.
• 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
⁃ At least two out of four of the following: PSA (Prostate Specific Antigen) 10-19.9, GS (Gleason Score) = 4+3, clinical stage = T2b/T2c, ≥50% positive biopsy cores.
• Subjects must freely sign informed consent to enroll in the study.
• Subjects must be medically fit to undergo surgery and HDR-B as determined by the PI.
• Age ≥ 40
• ECOG Performance Status (performance status is an attempt to quantify cancer patients\' general well-being and activities of daily life, scores range from 0 to 5 where 0 represents perfect health and 5 represents death): 0-1.
• No prior invasive malignancy in the past 3-years, except non-melanomatous skin cancer unless disease free for a minimum of 2 years. Carcinoma in-situ of the bladder or head and neck region is permissible.
• Subjects must not have had prior androgen deprivation therapy in the past 6 months.