Post-prostatectomy Radiation Therapy--Moderate Versus Ultra-hypofractionated (Also Known as Stereotactic Body Radiation Therapy [SBRT])

A Phase II Randomized Trial of Moderate Versus Ultra-hypofractionated Post-prostatectomy Radiation Therapy

The primary purpose of this study is to compare the quality of life (QOL) reported by prostate cancer patients 2 years after treatment with ultra-hypofractionated post-prostatectomy radiation therapy (also known as stereotactic body radiation therapy [SBRT]) versus the self-reported QOL of those treated with moderately hypo-fractionated post-prostatectomy radiation (a current standard of care option).

Conventional or moderately hypo-fractionated radiation therapy are the current standard of care treatment options for men receiving post-prostatectomy radiation therapy. These treatment regimens typically span 4-8 weeks, representing a high burden of therapy, which may result in decreased utilization of salvage radiotherapy, the only potentially curable treatment for men with relapsed disease following prostatectomy. Ultra-hypofractionated radiation therapy (also known as stereotactic body radiation therapy [SBRT]) would decrease the total number of treatments to 5, delivered over 2 weeks, which would greatly reduce treatment burden.

Inclusion Criteria:

• Men age ≥ 18 with histologically confirmed prostate cancer after radical prostatectomy with a PSA ≥ 0.1 ng/mL
• Interval between prostatectomy and planned radiation therapy start date ≥ 6 months
• KPS ≥ 70
• Patients with equivocal pelvic lymph nodes on imaging are eligible if the nodes are ≤ 1.5 cm in the short axis (equivocal evidence of metastatic disease outside of the pelvis on standard imaging requires documented negative biopsy)
• Ability to complete the EPIC-26 quality of life questionnaire
• Ability to obtain tissue from radical prostatectomy specimen for review by Michigan Medicine Pathology
• Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

• Prior history of pelvic radiation therapy
• History of moderate/severe or active Crohn's disease or ulcerative colitis
• History of bladder neck or urethral stricture
• Evidence of distant metastatic disease or nodal involvement beyond the common iliac vessels
• Initiation of androgen deprivation therapy with a LHRH / GnRH agonist or antagonist greater than 6 months prior to enrollment or receipt of any non-LHRH / GnRH agonist or antagonist androgen deprivation or anti-androgen therapy
• History of another invasive malignancy within the previous 3 years except for adequately treated squamous or basal cell skin cancer
• Any condition that in the opinion of the investigator would preclude participation in this study