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

January 15, 2026 updated by: University of Michigan Rogel Cancer Center

A Phase II Randomized Trial of Moderate Versus Ultra-hypofractionated Post-prostatectomy Radiation Therapy

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
136

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 98107
        • Recruiting
        • University of Michigan Rogel Cancer Center
        • Principal Investigator:
          • William Jackson, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Moderately Hypo-fractionated Radiation Therapy
20 fractions of moderately hypofractionated radiation therapy over no more than 5-6 weeks.
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)
Experimental: 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
Radiation: 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)
Other Names:
  • stereotactic body radiation therapy [SBRT]

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in patient reported GI and GU quality of life (QOL) at 2-years post-treatment from baseline
Time Frame: 2-years post-treatment
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient reported GU quality of life (QOL) up to 60 months
Time Frame: 60 months post-treatment
GU QOL assessed with the EPIC-26 questionnaire, urinary domain; at the end of radiation, 3, 6, 12, and 60 months post-treatment. 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 urinary score > 84, low urinary score <=84. A longitudinal analysis incorporating all follow-up time points, will be conducted separately for each domain score.
60 months post-treatment
Patient reported GI quality of life (QOL) up to 60 months
Time Frame: 60 months post-treatment
GI QOL assessed with the EPIC-26 questionnaire, bowel domain; at the end of radiation, 3, 6, 12, and 60 months post-treatment. 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. A longitudinal analysis incorporating all follow-up time points, will be conducted separately for each domain score.
60 months post-treatment
Treatment related toxicity - acute
Time Frame: ≤ 90 days after treatment completion
Treatment related toxicity (adverse events) assessed with CTCAE version 5.0
≤ 90 days after treatment completion
Treatment related toxicity - late
Time Frame: >90 days after treatment completion, up to 5 years
Treatment related toxicity (adverse events) assessed with CTCAE version 5.0
>90 days after treatment completion, up to 5 years
Time to progression
Time Frame: up to 5 years
Time to progression (where progression is defined as the first occurrence of biochemical failure, local failure, regional failure, distant metastasis, start of salvage therapy, or death from prostate cancer)
up to 5 years
Rate of biochemical failure
Time Frame: up to 5 years
Biochemical failure will be assessed using two definitions. Definition one is a PSA ≥ 0.4 ng/mL followed by a second higher value. Definition two is the post-radiation PSA nadir + 2ng/mL
up to 5 years
Local failure, Regional failure, Distant metastases
Time Frame: up to 5 years

Descriptive statistics will be used to describe the number of local, regional and distant metastases.

  • Local failure is defined as development of a new biopsy-proven mass or prostate specific PET avid mass in the prostate bed after completion of protocol treatment
  • Regional failure is defined as radiographic evidence of pelvic lymphadenopathy (lymph node size ≥ 1.5 cm in short axis) or PET avid lymph nodes within the pelvis following protocol treatment
  • Distant metastases is defined as any clinical or radiographic evidence of lymph node, bone, or visceral involvement of prostate cancer
up to 5 years
Prostate cancer specific survival
Time Frame: up to 5 years
Prostate cancer specific survival defined as the duration of time from the start of treatment to death attributable to prostate cancer. Patients who have not died or die of non-prostate cancer related causes will be censored at the date of last known follow-up or date of death, respectively.
up to 5 years
Overall survival
Time Frame: up to 5 years
Overall survival defined as the duration of time from the start of treatment to death from any cause. Patients who have not died will be censored at the date of last known follow-up.
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Michigan Rogel Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: William Jackson, M.D., University of Michigan Rogel Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 12, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UMCC 2021.046
  • HUM00200905 (Other Identifier: University of Michigan)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings