Prostate AdenocarcinomaPhase 2NCT03570827
Hypofractionated Radiation Therapy for Treating Prostate Cancer High-Risk Features Following Radical Prostatectomy
A Phase 2 study testing Androgen Suppression, Hypofractionated Radiation Therapy and Quality-of-Life Assessment in people with Prostate Adenocarcinoma and Stage IIB Prostate Cancer AJCC v8, run by Mayo Clinic at 2 sites in United States.
Trial summary
This phase II trial studies how well hypofractionated radiation therapy works in treating participants with prostate cancer high-risk features following radical prostatectomy. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma, Stage IIB Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8
- What is being tested?
- Androgen Suppression, Hypofractionated Radiation Therapy and Quality-of-Life Assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 May 2018to 15 May 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histologically confirmed prostate adenocarcinoma at the time of surgery
- Pathologic stages T2-T3b, N0-Nx-N1, M0-1 as staged by the pathology report (American Joint Committee on Cancer [AJCC] criteria 8th edition [Ed.])
- One or more high risk features including: seminal vesicle invasion, extracapsular extension, positive margins, or a PSA post surgery between 0.2 and < 2.0
- PSA values < 2 ng/ml within 90 days prior to enrollment. Obtained at least 6 weeks after surgery
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 assessed within 90 days of enrollment
- Patients must sign Institutional Review Board (IRB) approved study specific informed consent
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- Patients must complete all required pre-entry tests within the specified time frames
- Patients must be able to start treatment (androgen suppression [AS] or radiation) within 120 days of study registration
- Members of all races and ethnic groups are eligible for this trial
- Patients from outside of the United States may participate in the study
Who cannot join
- Previous pelvic radiation
- Prior androgen suppression therapy for prostate cancer for more than 6 months
- Active rectal diverticulitis, Crohn's disease affecting the rectum or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed)
- Prior systemic chemotherapy for prostate cancer
- History of proximal urethral stricture requiring dilatation
- Current and continuing anticoagulation with warfarin sodium (coumadin), heparin, low- molecular weight heparin, Clopidogrel bisulfate (plavix), or equivalent (unless it can be stopped to manage treatment related toxicity, to have a biopsy if needed, or place markers)
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- Major medical, addictive or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (Consent by legal authorized representative is not permitted for this study)
- Evidence of any other cancer within the past 5 years and < 50% probability of a 5 year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed)
- History of myocardial infarction or decompensated congestive heart failure (CHF) within the last 6 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
About this study
Official title: A Phase II Trial of Hypofractionated Radiation Therapy for Prostate Cancer With High Risk Features After Radical Prostatectomy
This phase II trial studies how well hypofractionated radiation therapy works in treating participants with prostate cancer high-risk features following radical prostatectomy. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine if stereotactic body radiation therapy (SBRT) would result in similar freedom from failure (FFF) than standard fractionation photon therapy.
EXPLORATORY OBJECTIVES:
- After completion of radiation therapy, determine the incidence of grade 2 or greater genitourinary (GU) and gastrointestinal (GI) toxicity at 6 months (Common Terminology Criteria for Adverse Events [CTCAE] version 4).
II. After completion of radiation therapy, determine the incidence of grade 3 or greater GU and GI toxicity at 6 months (CTCAE version 4).
III. After completion of radiation therapy, determine the incidence of quality of life issues following completion of radiation therapy.
IV. After completion of radiation therapy, determine the incidence of impotence after the use of radiation therapy at 3 years.
- After completion of radiation therapy, determine the incidence of freedom from biochemical failure (FFBF) at 5 years.
VI. After completion of radiation therapy, determine the incidence of clinical failure: local and/or distant at 5 years.
VII. After completion of radiation therapy, determine the incidence of salvage androgen deprivation use (SAD) at 5 years.
VIII. After completion of radiation therapy, determine the incidence of progression free survival: using clinical, biochemical and SAD as events at 5 years.
IX. After completion of radiation therapy, determine the incidence of overall survival at 5 years.
- After completion of radiation therapy, determine the incidence of disease-specific survival at 5 years.
XI. Determine the impact of radiation therapy on quality of life. XII. Determine overall GI and GU toxicity. XIII. Determine prostate and normal structure movement during radiation therapy (RT) with the use of scans.
XIV. Correlate pathologic and radiologic findings with outcomes. XV. Correlate pre-RT prostate specific antigen (PSA) levels with outcomes. XVI. Correlate variation in proton therapy or x-ray dosimetry and outcomes. XVII. Develop a quality assurance process for prostate proton therapy. XVIII. Prospectively collect information that will help to define dose-volume relationships of normal structures with acute and chronic toxicity.
XIX. Allow for future research of pathologic risk factors that may influence prognosis; this information will help us to attempt to characterize their presence in prostate cancer with high risk features after prostatectomy and their potential effect on outcomes.
XX. Possibly compare dosimetric parameters of an IMRT plan with the proton therapy radiation plan.
OUTLINE: Participants are assigned to 1 of 3 groups.
GROUP I: Participants undergo hypofractionated radiation therapy over 15-30 minutes every other day over 2 weeks, for 5 treatments.
GROUP II: Beginning 8-10 weeks before radiation therapy, participants receive androgen suppression therapy subcutaneously (SC) or intramuscularly (IM) for up to 6 months (at the discretion of the treating physician). Participants then undergo hypofractionated radiation therapy as Group I.
GROUP III: Participants receive androgen suppression therapy as Group II for up to 18 months (at the discretion of the treating physician), then undergo hypofractionated radiation therapy over 15-30 minutes every other day over 1-2 weeks, for 1-5 treatments.
After completion of study treatment, participants are followed up at 3 and 12 months, annually for 4 years, then every 2 years thereafter.
- Conditions
- Prostate Adenocarcinoma, Stage IIB Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8
- Being tested
- Androgen Suppression, Hypofractionated Radiation Therapy, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Androgen SuppressionDrug
Also called Androgen Ablation, androgen deprivation
Given androgen suppression therapy
Hypofractionated Radiation TherapyRadiation
Also called Hypofractionated Radiotherapy, hypofractionation, Radiation, Hypofractionated
Undergo hypofractionated radiation therapy
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (hypofractionated radiation therapy) | Experimental | Participants undergo hypofractionated radiation therapy over 15-30 minutes every other day over 2 weeks, for 5 treatments. Receives: Radiation: Hypofractionated Radiation Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Group II (radiation therapy, androgen suppression therapy) | Experimental | Beginning 8-10 weeks before radiation therapy, participants receive androgen suppression therapy SC or IM for up to 6 months (at the discretion of the treating physician). Participants then undergo hypofractionated radiation therapy as Group I. Receives: Drug: Androgen Suppression; Radiation: Hypofractionated Radiation Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Group III (radiation therapy, androgen suppression therapy) | Experimental | Participants receive androgen suppression therapy as Group II for up to 18 months (at the discretion of the treating physician), then undergo hypofractionated radiation therapy over 15-30 minutes every other day over 1-2 weeks, for 1-5 treatments. Receives: Drug: Androgen Suppression; Radiation: Hypofractionated Radiation Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom From Failure (FFF)
Will be defined as the first occurrence of clinical failure (local recurrence, regional recurrence, or distant metastasis), the start/re-start of salvage therapy including androgen suppression, and biochemical failure (PSA >= 0.5 ng/ml). The count and percentage of patient free from failure will be reported.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start14 May 2018
- Primary completion15 May 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos E. Vargas, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570827
- Sponsor's protocol ID
- MC1754
- Other IDs
- NCI-2018-00943, MC1754, 17-009199
- Status last verified
- Aug 2025
- First submitted
- 5 Jun 2018
- Last updated
- 26 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Hypofractionated Radiation Therapy for Prostate Cancer With High Risk Features After Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT03570827
- Acronym / sponsor ID
- MC1754
- Conditions
- Prostate Adenocarcinoma, Stage IIB Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 14 May 2018 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 27 Jun 2018 (actual)
- Results
- Posted 26 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well hypofractionated radiation therapy works in treating participants with prostate cancer high-risk features following radical prostatectomy. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.
Detailed description
PRIMARY OBJECTIVE:
- To determine if stereotactic body radiation therapy (SBRT) would result in similar freedom from failure (FFF) than standard fractionation photon therapy.
EXPLORATORY OBJECTIVES:
- After completion of radiation therapy, determine the incidence of grade 2 or greater genitourinary (GU) and gastrointestinal (GI) toxicity at 6 months (Common Terminology Criteria for Adverse Events [CTCAE] version 4).
II. After completion of radiation therapy, determine the incidence of grade 3 or greater GU and GI toxicity at 6 months (CTCAE version 4).
III. After completion of radiation therapy, determine the incidence of quality of life issues following completion of radiation therapy.
IV. After completion of radiation therapy, determine the incidence of impotence after the use of radiation therapy at 3 years.
- After completion of radiation therapy, determine the incidence of freedom from biochemical failure (FFBF) at 5 years.
VI. After completion of radiation therapy, determine the incidence of clinical failure: local and/or distant at 5 years.
VII. After completion of radiation therapy, determine the incidence of salvage androgen deprivation use (SAD) at 5 years.
VIII. After completion of radiation therapy, determine the incidence of progression free survival: using clinical, biochemical and SAD as events at 5 years.
IX. After completion of radiation therapy, determine the incidence of overall survival at 5 years.
- After completion of radiation therapy, determine the incidence of disease-specific survival at 5 years.
XI. Determine the impact of radiation therapy on quality of life. XII. Determine overall GI and GU toxicity. XIII. Determine prostate and normal structure movement during radiation therapy (RT) with the use of scans.
XIV. Correlate pathologic and radiologic findings with outcomes. XV. Correlate pre-RT prostate specific antigen (PSA) levels with outcomes. XVI. Correlate variation in proton therapy or x-ray dosimetry and outcomes. XVII. Develop a quality assurance process for prostate proton therapy. XVIII. Prospectively collect information that will help to define dose-volume relationships of normal structures with acute and chronic toxicity.
XIX. Allow for future research of pathologic risk factors that may influence prognosis; this information will help us to attempt to characterize their presence in prostate cancer with high risk features after prostatectomy and their potential effect on outcomes.
XX. Possibly compare dosimetric parameters of an IMRT plan with the proton therapy radiation plan.
OUTLINE: Participants are assigned to 1 of 3 groups.
GROUP I: Participants undergo hypofractionated radiation therapy over 15-30 minutes every other day over 2 weeks, for 5 treatments.
GROUP II: Beginning 8-10 weeks before radiation therapy, participants receive androgen suppression therapy subcutaneously (SC) or intramuscularly (IM) for up to 6 months (at the discretion of the treating physician). Participants then undergo hypofractionated radiation therapy as Group I.
GROUP III: Participants receive androgen suppression therapy as Group II for up to 18 months (at the discretion of the treating physician), then undergo hypofractionated radiation therapy over 15-30 minutes every other day over 1-2 weeks, for 1-5 treatments.
After completion of study treatment, participants are followed up at 3 and 12 months, annually for 4 years, then every 2 years thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (hypofractionated radiation therapy) | Experimental | Radiation: Hypofractionated Radiation Therapy, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationParticipants undergo hypofractionated radiation therapy over 15-30 minutes every other day over 2 weeks, for 5 treatments. |
| Group II (radiation therapy, androgen suppression therapy) | Experimental | Drug: Androgen Suppression, Radiation: Hypofractionated Radiation Therapy, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationBeginning 8-10 weeks before radiation therapy, participants receive androgen suppression therapy SC or IM for up to 6 months (at the discretion of the treating physician). Participants then undergo hypofractionated radiation therapy as Group I. |
| Group III (radiation therapy, androgen suppression therapy) | Experimental | Drug: Androgen Suppression, Radiation: Hypofractionated Radiation Therapy, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationParticipants receive androgen suppression therapy as Group II for up to 18 months (at the discretion of the treating physician), then undergo hypofractionated radiation therapy over 15-30 minutes every other day over 1-2 weeks, for 1-5 treatments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed prostate adenocarcinoma at the time of surgery
- Pathologic stages T2-T3b, N0-Nx-N1, M0-1 as staged by the pathology report (American Joint Committee on Cancer [AJCC] criteria 8th edition [Ed.])
- One or more high risk features including: seminal vesicle invasion, extracapsular extension, positive margins, or a PSA post surgery between 0.2 and < 2.0
- PSA values < 2 ng/ml within 90 days prior to enrollment. Obtained at least 6 weeks after surgery
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 assessed within 90 days of enrollment
Key exclusion criteria (9 listed)
- Previous pelvic radiation
- Prior androgen suppression therapy for prostate cancer for more than 6 months
- Active rectal diverticulitis, Crohn's disease affecting the rectum or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed)
- Prior systemic chemotherapy for prostate cancer
- History of proximal urethral stricture requiring dilatation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Androgen SuppressionAlso: Androgen Ablation, androgen deprivationGiven androgen suppression therapy | Drug | Group II (radiation therapy, androgen suppression therapy), Group III (radiation therapy, androgen suppression therapy) |
| Hypofractionated Radiation TherapyAlso: Hypofractionated Radiotherapy, hypofractionation, Radiation, HypofractionatedUndergo hypofractionated radiation therapy | Radiation | Group I (hypofractionated radiation therapy), Group II (radiation therapy, androgen suppression therapy), Group III (radiation therapy, androgen suppression therapy) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Group I (hypofractionated radiation therapy), Group II (radiation therapy, androgen suppression therapy), Group III (radiation therapy, androgen suppression therapy) |
| Questionnaire AdministrationAncillary studies | Other | Group I (hypofractionated radiation therapy), Group II (radiation therapy, androgen suppression therapy), Group III (radiation therapy, androgen suppression therapy) |
Primary outcome
Freedom From Failure (FFF)
Time frame: 5 years
Will be defined as the first occurrence of clinical failure (local recurrence, regional recurrence, or distant metastasis), the start/re-start of salvage therapy including androgen suppression, and biochemical failure (PSA >= 0.5 ng/ml). The count and percentage of patient free from failure will be reported.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos E. Vargas, M.D. principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Androgen Suppression, Hypofractionated Radiation Therapy and Quality-of-Life Assessment in people with Prostate Adenocarcinoma and Stage IIB Prostate Cancer AJCC v8, run by Mayo Clinic at 2 sites 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 10 inclusion and 9 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: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 26 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom From Failure (FFF) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 May 2026.