Neoadjuvant Stereotactic Body Radiotherapy Prior to Radical Prostatectomy for High Risk Prostate Cancer

A Phase I Trial of Neoadjuvant Stereotactic Body Radiotherapy Prior to Radical Prostatectomy for High Risk Prostate Cancer

This is a single-arm prospective non-randomized, non-blinded trial to assess the safety of neoadjuvant stereotactic body radiation therapy (SBRT) before surgery in high risk prostate cancer patients.

Radiation therapy will be delivered over 5 treatment sessions for approximately 1.5 weeks total.

Inclusion Criteria:

• Subjects must have biopsy-confirmed adenocarcinoma of the prostate.
• Subjects must have a negative bone scan.
• 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) 7th Edition Staging Manual and/or
• Radiographic pelvic lymph node positive disease and/or
• At least two out of four of the following: PSA (Prostate Specific Antigen) 10-19.9, GS (Gleason Score) = 3+4, 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 determined by the PI.
• Age ≥ 18
• KPS Karnofsky Performance Status (performance status is an attempt to quantify cancer patients' general well-being and activities of daily life, scores range from 0 to 100 where 100 represents perfect health and 0 represents death): ≥70.
• 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 pelvic radiation therapy,
• Subjects must not have had prior androgen deprivation therapy in the past 6 months.

Exclusion Criteria:

• Metastatic disease as demonstrated by bone scan, CT scan or MRI (Magnetic Resonance Imaging) of the pelvis, or chest x-ray.
• Declared high-risk for anesthesia by attending anesthesiologist, cardiologist, or other physician.
• History of prior pelvic radiation therapy.
• History of androgen deprivation therapy within the past 6 months.