Comparing two types of radiation therapy for prostate cancer after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.