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

NCT ID: NCT05038332

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-12
• Study Completion Date: 2029-11-30

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).

Detailed Description

Conventional or moderately hypo-fractionated radiation therapy are the current standard of care treatment options for men receiving post-prostatectomy radiation therapy. These treatment regimens typically span 4-8 weeks, representing a high burden of therapy, which may result in decreased utilization of salvage radiotherapy, the only potentially curable treatment for men with relapsed disease following prostatectomy. Ultra-hypofractionated radiation therapy (also known as stereotactic body radiation therapy [SBRT]) would decrease the total number of treatments to 5, delivered over 2 weeks, which would greatly reduce treatment burden.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Moderately Hypo-fractionated Radiation Therapy

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

Group Type: ACTIVE_COMPARATOR

Moderately Hypo-fractionated Radiation Therapy

Intervention Type: 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)

Ultra-Hypofractionated Radiation Therapy

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

Group Type: EXPERIMENTAL

Ultra-hypofractionated radiation therapy

Intervention Type: 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)

Interventions

Ultra-hypofractionated radiation therapy

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)

Intervention Type: RADIATION

Moderately Hypo-fractionated Radiation Therapy

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

Intervention Type: RADIATION

Other Intervention Names

stereotactic body radiation therapy [SBRT]

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Jackson, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Cancer AnswerLine

Role: CONTACT

CancerAnswerLine@med.umich.edu

1-800-865-1125

Other Identifiers

HUM00200905

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2021.046

Identifier Type: -

Identifier Source: org_study_id