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

NCT05038332 | Recruiting Phase 2 FDA Device

• 2 other identifiers: UMCC 2021.046HUM00200905
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

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

Prostate Cancer

Keywords

Stereotactic Body Radiation Therapy (SBRT); Ultra-hypofractionated Radiation Therapy; Post-prostatectomy

Outcome Measures

Primary Outcomes (1)

• Change in patient reported GI and GU quality of life (QOL) at 2-years post-treatment from baseline

  GI and GU QOL assessed with the EPIC-26 questionnaire, bowel and urinary domains. Change scores will be calculated as baseline score subtracted from 2-year score. All patients with EPIC bowel and urinary domain scores will be included in the primary endpoint analysis. The EPIC scoring manual will be followed which requires ≥ 80% of items in a domain to be completed in order to obtain a score for that domain. High bowel score \>96, low bowel score \<= 96, high urinary score \> 84, low urinary score \<=84.

  2-years post-treatment

Secondary Outcomes (9)

• Patient reported GU quality of life (QOL) up to 60 months

  60 months post-treatment

• Patient reported GI quality of life (QOL) up to 60 months

  60 months post-treatment

• Treatment related toxicity - acute

  ≤ 90 days after treatment completion

• Treatment related toxicity - late

  >90 days after treatment completion, up to 5 years

• Time to progression

  up to 5 years

Study Arms (2)

Moderately Hypo-fractionated Radiation Therapy

ACTIVE COMPARATOR

20 fractions of moderately hypofractionated radiation therapy over no more than 5-6 weeks.

Radiation: Moderately Hypo-fractionated Radiation Therapy

Ultra-Hypofractionated Radiation Therapy

EXPERIMENTAL

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

Radiation: Ultra-hypofractionated radiation therapy

Interventions

Moderately Hypo-fractionated Radiation Therapy RADIATION

55 Gy in 20 fractions to prostate bed, daily, M-F, 4 weeks (42 Gy in 20 fractions to pelvic lymph nodes if included)

Moderately Hypo-fractionated Radiation Therapy

Ultra-hypofractionated radiation therapy RADIATION

34 Gy in 5 fractions to prostate bed, every other day, M-F, \~2 weeks (25 Gy in 5 fractions to pelvic lymph nodes if included)

Also known as: stereotactic body radiation therapy [SBRT]

Ultra-Hypofractionated Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 98107, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• William Jackson, M.D.

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cancer AnswerLine

CONTACT

1-800-865-1125; CancerAnswerLine@med.umich.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 9, 2021
• Study Start: November 12, 2021
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2029
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)