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

University of Michigan Rogel Cancer Center

Status and phase

Completed

Phase 1

Conditions

Prostate Cancer

Treatments

Procedure: Radical Prostatectomy

Radiation: Stereotactic Body Radiation Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02946008

UMCC 2016.106

HUM00120414 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.