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

Launched by UNIVERSITY OF MICHIGAN ROGEL CANCER CENTER · Aug 31, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring two different types of radiation therapy for men with prostate cancer who have undergone surgery to remove their prostate (called radical prostatectomy). The main goal is to find out how each type of treatment affects patients' quality of life two years after the therapy. One approach being studied is called ultra-hypofractionated radiation therapy, which delivers higher doses of radiation in fewer sessions. The other method is moderately hypo-fractionated radiation therapy, which is a standard treatment option.

To participate in this trial, men must be at least 18 years old, have had surgery for prostate cancer, and have a small amount of prostate-specific antigen (PSA) in their blood after surgery. They should also be able to answer questions about their quality of life and provide tissue samples from their surgery for further analysis. Participants can expect to receive either type of radiation therapy and will be monitored for their experiences and side effects throughout the study. This trial is currently recruiting, so interested individuals should discuss it with their healthcare provider for more information.

Gender

MALE

Eligibility criteria

• 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