Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Moderately Hypo-fractionated Radiation Therapy | Radiation | — | UNRESOLVED |
| Ultra-hypofractionated radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Moderately Hypo-fractionated Radiation Therapy
- description
- 20 fractions of moderately hypofractionated radiation therapy over no more than 5-6 weeks.
- interventionNames
- Radiation: Moderately Hypo-fractionated Radiation Therapy
- type
- EXPERIMENTAL
- label
- Ultra-Hypofractionated Radiation Therapy
- description
- 5 fractions of ultra-hypofractionated radiation therapy with at least one day between each treatment over the course of no more than 3-4 weeks
- interventionNames
- Radiation: Ultra-hypofractionated radiation therapy
Primary outcomes (1)
- measure
- Change in patient reported GI and GU quality of life (QOL) at 2-years post-treatment from baseline
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available