Comparing two types of radiation therapy for prostate cancer after surgery
A Phase II Randomized Trial of Moderate Versus Ultra-hypofractionated Post-prostatectomy Radiation Therapy
This study is testing whether a shorter, five-session radiation therapy for prostate cancer after surgery helps patients feel better compared to a longer treatment that takes several weeks.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 136 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of Michigan Rogel Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT05038332 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the quality of life reported by prostate cancer patients two years after receiving either ultra-hypofractionated radiation therapy (SBRT) or moderately hypo-fractionated radiation therapy following prostatectomy. The conventional treatment typically requires 4-8 weeks of therapy, which can be burdensome and may lead to lower utilization of salvage radiotherapy. In contrast, the ultra-hypofractionated approach reduces the treatment duration to just 5 sessions over 2 weeks, potentially easing the treatment burden on patients. The study will assess the impact of these two approaches on patients' quality of life using the EPIC-26 questionnaire.
Who should consider this trial
Good fit: Ideal candidates include men aged 18 and older with confirmed prostate cancer who have undergone radical prostatectomy and have a PSA level of 0.1 ng/mL or higher.
Not a fit: Patients with a history of pelvic radiation therapy or evidence of distant metastatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more efficient and less burdensome radiation therapy option for prostate cancer patients post-surgery.
How similar studies have performed: Other studies have shown promising results with ultra-hypofractionated radiation therapy, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ann Arbor, Michigan
- University of Michigan Rogel Cancer Center — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: William Jackson, M.D. — University of Michigan Rogel Cancer Center
- Study coordinator: Cancer AnswerLine
- Email: CancerAnswerLine@med.umich.edu
- Phone: 1-800-865-1125
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.