AzTrials
AzTrials

Prostate CancerPhase 2NCT05038332

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

A Phase 2 study testing Ultra-hypofractionated radiation therapy and Moderately Hypo-fractionated Radiation Therapy in people with Prostate Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Ultra-hypofractionated radiation therapy and Moderately Hypo-fractionated Radiation Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
1 siteUnited States
Study dates
12 Nov 2021to Nov 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Cancer AnswerLine contact

1-800-865-1125

CancerAnswerLine@med.umich.edu

United States1 site, 1 recruiting

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 98107

    William Jackson, MD

    Recruiting

Other trials in United States

About this study

Official title: 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).

Read the 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
Being tested
Ultra-hypofractionated radiation therapy, Moderately Hypo-fractionated Radiation Therapy
Keywords
Stereotactic Body Radiation Therapy (SBRT), Ultra-hypofractionated Radiation Therapy, Post-prostatectomy
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultra-hypofractionated radiation therapyRadiation

    Also called stereotactic body radiation therapy [SBRT]

    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)

  • Moderately Hypo-fractionated Radiation TherapyRadiation

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

Study groups in NCT05038332
Study groupRoleWhat they receive
Moderately Hypo-fractionated Radiation TherapyActive comparator20 fractions of moderately hypofractionated radiation therapy over no more than 5-6 weeks.
Receives: Radiation: Moderately Hypo-fractionated Radiation Therapy
Ultra-Hypofractionated Radiation TherapyExperimental5 fractions of ultra-hypofractionated radiation therapy with at least one day between each treatment over the course of no more than 3-4 weeks
Receives: Radiation: Ultra-hypofractionated radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2-years post-treatment

Secondary outcomes (9)

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

    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.

    Measured: 60 months post-treatment

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

    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.

    Measured: 60 months post-treatment

  3. Treatment related toxicity - acute

    Treatment related toxicity (adverse events) assessed with CTCAE version 5.0

    Measured: ≤ 90 days after treatment completion

  4. Treatment related toxicity - late

    Treatment related toxicity (adverse events) assessed with CTCAE version 5.0

    Measured: >90 days after treatment completion, up to 5 years

  5. Time to progression

    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)

    Measured: up to 5 years

  6. Rate of biochemical failure

    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

    Measured: up to 5 years

  7. Local failure, Regional failure, Distant metastases

    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

    Measured: up to 5 years

  8. Prostate cancer specific survival

    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.

    Measured: up to 5 years

  9. Overall survival

    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.

    Measured: up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2021
  2. Study start12 Nov 2021
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
136 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05038332
Sponsor's protocol ID
UMCC 2021.046
Other IDs
HUM00200905
Status last verified
Jan 2026
First submitted
31 Aug 2021
Last updated
16 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ultra-hypofractionated radiation therapy and Moderately Hypo-fractionated Radiation Therapy in people with Prostate Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cancer AnswerLine (1-800-865-1125, CancerAnswerLine@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in patient reported GI and GU quality of life (QOL) at 2-years post-treatment from baseline (time frame: 2-years post-treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05038332.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in