Biochemically Recurrent Prostate CarcinomaPhase 3NCT06205316
SBRT Versus Hypofractionated Radiotherapy for Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma
A Phase 3 study testing Antiandrogen Therapy, Biospecimen Collection and Hypofractionated Radiation Therapy in people with Biochemically Recurrent Prostate Carcinoma and Oligometastatic Prostate Carcinoma, run by Mayo Clinic at 6 sites in United States.
Trial summary
This phase III trial tests the side effects of stereotactic body radiation therapy (SBRT) compared to hypofractionated radiotherapy for treating patients with prostate adenocarcinoma that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to a limited… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Biochemically Recurrent Prostate Carcinoma, Oligometastatic Prostate Carcinoma, Recurrent Prostate Adenocarcinoma
- What is being tested?
- Antiandrogen Therapy, Biospecimen Collection and Hypofractionated Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 6 sitesUnited States
- Study dates
- 4 Apr 2024to 25 Sep 2028
- Phase
- Phase 3
- 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
- Histologically confirmed prostate adenocarcinoma at the time of surgery
- Pathologic stages T2-T3b, Nx or N0-1, M0-1 as staged by the pathology report (American Joint Committee on Cancer [AJCC] Criteria 8th edition [Ed.])
- PSA post radical prostatectomy ≥ 0.1 and < 2.0 ng/mL ≤ 90 days prior to enrollment, obtained ≥ 6 weeks after surgery
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 assessed ≤ 90 days of enrollment
- Patients must sign institutional review board (IRB) approved study specific informed consent
- Patients must complete all required pre-entry tests within the specified time frames
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- Patients must be able to start treatment (ADT or radiation) ≤ 120 days of study registration
- Patients must be ≥ 18 years old
- Prostate cancer up to oligometastatic disease, up to 5 sites
Who cannot join
- Previous pelvic radiation
- Prior androgen deprivation therapy for prostate cancer and PSA ≥ 0.1 ng/mL
- 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
- 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)
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- History of myocardial infarction or decompensated congestive heart failure (CHF) within the last 6 months
- On a transplant list
- More than oligometastatic disease > 5 metastatic sites
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, 56007
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin, 54701
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, 54601
Mayo Clinic Health System - Mankato
Mankato, Minnesota, 56001
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
About this study
Official title: Randomized Phase III Trial of SBRT Versus Hypofractionated Radiotherapy for Salvage of Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma After Radical Prostatectomy
This phase III trial tests the side effects of stereotactic body radiation therapy (SBRT) compared to hypofractionated radiotherapy for treating patients with prostate adenocarcinoma that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to a limited number of sites (oligometastatic). SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumors cells and have fewer side effects. SBRT may work just as well as hypofractionated radiation therapy at treating patients with biochemically recurrent or oligometastatic prostate cancer, but with a shorter treatment time and possibly fewer side effects.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine if salvage SBRT is non-inferior to moderately hypofractionated radiation therapy regarding treatment related rates of genitourinary (GU) and gastrointestinal (GI) grade 3 or higher within 2-years.
EXPLORATORY OBJECTIVES:
- After completion of radiation therapy, determine the incidence of:
Ia. Disease free survival (DFS), defined as the first occurrence of new clinical failure (local recurrence, regional recurrence, or distant metastasis) after salvage radiation therapy (RT); Ib. Grade 2 or greater GU and GI toxicity at 3 years [Common Terminology Criteria for Adverse Events (CTCAE) version 5]; Ic. Grade 3 or greater GU and GI toxicity at 3 years (CTCAE version 5); Id. Quality of life following completion of radiation therapy; Ie. Impotence after the use of radiation therapy at 3 years; If. Freedom from biochemical failure (FFBF) at 5 years; Ig. Local failure at 5 years; Ih. Regional failure at 5 years; Ii. Distant failure at 5 years; Ij. Salvage androgen deprivation therapy (ADT) use (SAD) at 5 years; Ik. Progression free survival: using clinical, biochemical and SAD as events at 5 years; Il. Overall survival at 5 years; Im. Disease-specific survival at 5 years. II. Determine the impact of salvage SBRT and hypofractionated radiation therapy (HFRT) on quality of life.
III. Determine prostate and normal structure movement during RT with the use of scans.
IV. Correlate pathologic and radiologic findings with outcomes. V. Correlate pre-RT prostate specific antigen (PSA) levels with outcomes. VI. Prospectively collect information that will help to define dose-volume relationships of normal structures with acute and chronic toxicity.
VII. 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.
VIII. Prospectively record contours that were manually drawn versus (vs.) edited from artificial intelligence (AI)-generated contours.
IX. Determine the impact of using artificial intelligence (AI) tools for automatic segmenting prostate bed and other organs at risk, in terms of toxicities and outcome.
- Determine if there are any significant differences in dose-volumes results for cases that involved AI-autosegmentation vs. cases without.
XI. Determine the relationship between the use of AI-autosegmentation tools with toxicities and outcome.
XII. Different online daily imaging guidance systems are allowed in this trial, including x-rays, conventional Feldkamp-Davis-Kress (FDK)-based cone beam computed tomography (CBCT), and iterative CBCT. Subgroup analysis will be performed to determine patient alignment accuracy and toxicities rates with respect to different online daily imaging systems.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients undergo SBRT over 15-20 minutes every other day for a total of 5 treatments over 1-2 weeks in the absence of disease progression or unacceptable toxicity. Patients may receive androgen deprivation therapy for up to 18 months, as clinically indicated. Patients undergo positron emission tomography (PET) at screening and treatment failure, and blood sample collection throughout the study. Patients may also undergo magnetic resonance imaging (MRI) as clinically indicated at screening and treatment failure.
GROUP II: Patients undergo hypofractionated radiation therapy over 15-20 minutes once per day for a total of 20 treatments over 4-6 weeks in the absence of disease progression or unacceptable toxicity. Patients may receive androgen deprivation therapy for up to 18 months, as clinically indicated. Patients undergo PET at screening and treatment failure, and blood sample collection throughout the study. Patients may also undergo MRI as clinically indicated at screening and treatment failure.
After completion of study treatment, patients follow up at 3 months, 12 months, annually until year 5, and then optionally and per physician guidance every other year until death.
- Conditions
- Biochemically Recurrent Prostate Carcinoma, Oligometastatic Prostate Carcinoma, Recurrent Prostate Adenocarcinoma, Stage IIB Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8
- Being tested
- Antiandrogen Therapy, Biospecimen Collection, Hypofractionated Radiation Therapy, Positron Emission Tomography, Stereotactic Body Radiation Therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiandrogen TherapyDrug
Also called ADT, Androgen Deprivation Therapy, Androgen Deprivation Therapy (ADT), Anti-androgen Therapy
Receive ADT
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Hypofractionated Radiation TherapyRadiation
Also called Hypofractionated, Hypofractionated Radiotherapy, hypofractionation, Radiation, Hypofractionated
Undergo hypofractionated radiation therapy
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)
Undergo PET scan
Stereotactic Body Radiation TherapyRadiation
Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Undergo SBRT
Survey AdministrationOther
Ancillary study
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance Imaging (MRI), MRI, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
| Study group | Role | What they receive |
|---|---|---|
| Group I (SBRT) | Experimental | Patients undergo SBRT over 15-20 minutes every other day for a total of 5 treatments over 1-2 weeks in the absence of disease progression or unacceptable toxicity. Patients may receive androgen deprivation therapy for up to 18 months, as clinically indicated. Patients undergo PET at screening and treatment failure, and blood sample collection throughout the study. Patients may also undergo MRI as clinically indicated at screening and treatment failure. Receives: Drug: Antiandrogen Therapy; Procedure: Biospecimen Collection; Procedure: Positron Emission Tomography; Radiation: Stereotactic Body Radiation Therapy; Other: Survey Administration; Procedure: Magnetic Resonance Imaging |
| Group II (Hypofractionated radiation therapy) | Experimental | Patients undergo hypofractionated radiation therapy over 15-20 minutes once per day for a total of 20 treatments over 4-6 weeks in the absence of disease progression or unacceptable toxicity. Patients may receive androgen deprivation therapy for up to 18 months, as clinically indicated. Patients undergo PET at screening and treatment failure, and undergo blood sample collection throughout the study. Patients may also undergo MRI as clinically indicated at screening and treatment failure. Receives: Drug: Antiandrogen Therapy; Procedure: Biospecimen Collection; Radiation: Hypofractionated Radiation Therapy; Procedure: Positron Emission Tomography; Other: Survey Administration; Procedure: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of grade 3 or higher genitourinary (GU)/gastrointestinal (GI) radiation treatment-related adverse events
Defined as the proportion of patients experiencing an increase in GU/GI Common Terminology Criteria for Adverse Events version 5.0 to grade 3+ compared to pre-radiation therapy GU/GI toxicity over the number of patients eligible for toxicity evaluation at 2 years from the start of radiation therapy. This endpoint will be compared between patients treated with stereotactic body radiation therapy and hypofractionated radiation therapy.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start4 Apr 2024
- Primary completion25 Sep 2028 (estimated)
- Study completion25 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biochemically Recurrent Prostate CarcinomaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos E. Vargas, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205316
- Sponsor's protocol ID
- GMROA2255
- Other IDs
- 22-009244
- Status last verified
- Sep 2026
- First submitted
- 4 Jan 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase III Trial of SBRT Versus Hypofractionated Radiotherapy for Salvage of Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma After Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT06205316
- Acronym / sponsor ID
- GMROA2255
- Conditions
- Biochemically Recurrent Prostate Carcinoma, Oligometastatic Prostate Carcinoma, Recurrent Prostate Adenocarcinoma, Stage IIB Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 25 Sep 2028 (estimated)
- Study completion
- 25 Sep 2028 (estimated)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase III trial tests the side effects of stereotactic body radiation therapy (SBRT) compared to hypofractionated radiotherapy for treating patients with prostate adenocarcinoma that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to a limited number of sites (oligometastatic). SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumors cells and have fewer side effects. SBRT may work just as well as hypofractionated radiation therapy at treating patients with biochemically recurrent or oligometastatic prostate cancer, but with a shorter treatment time and possibly fewer side effects.
Detailed description
PRIMARY OBJECTIVE:
- To determine if salvage SBRT is non-inferior to moderately hypofractionated radiation therapy regarding treatment related rates of genitourinary (GU) and gastrointestinal (GI) grade 3 or higher within 2-years.
EXPLORATORY OBJECTIVES:
- After completion of radiation therapy, determine the incidence of:
Ia. Disease free survival (DFS), defined as the first occurrence of new clinical failure (local recurrence, regional recurrence, or distant metastasis) after salvage radiation therapy (RT); Ib. Grade 2 or greater GU and GI toxicity at 3 years [Common Terminology Criteria for Adverse Events (CTCAE) version 5]; Ic. Grade 3 or greater GU and GI toxicity at 3 years (CTCAE version 5); Id. Quality of life following completion of radiation therapy; Ie. Impotence after the use of radiation therapy at 3 years; If. Freedom from biochemical failure (FFBF) at 5 years; Ig. Local failure at 5 years; Ih. Regional failure at 5 years; Ii. Distant failure at 5 years; Ij. Salvage androgen deprivation therapy (ADT) use (SAD) at 5 years; Ik. Progression free survival: using clinical, biochemical and SAD as events at 5 years; Il. Overall survival at 5 years; Im. Disease-specific survival at 5 years. II. Determine the impact of salvage SBRT and hypofractionated radiation therapy (HFRT) on quality of life.
III. Determine prostate and normal structure movement during RT with the use of scans.
IV. Correlate pathologic and radiologic findings with outcomes. V. Correlate pre-RT prostate specific antigen (PSA) levels with outcomes. VI. Prospectively collect information that will help to define dose-volume relationships of normal structures with acute and chronic toxicity.
VII. 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.
VIII. Prospectively record contours that were manually drawn versus (vs.) edited from artificial intelligence (AI)-generated contours.
IX. Determine the impact of using artificial intelligence (AI) tools for automatic segmenting prostate bed and other organs at risk, in terms of toxicities and outcome.
- Determine if there are any significant differences in dose-volumes results for cases that involved AI-autosegmentation vs. cases without.
XI. Determine the relationship between the use of AI-autosegmentation tools with toxicities and outcome.
XII. Different online daily imaging guidance systems are allowed in this trial, including x-rays, conventional Feldkamp-Davis-Kress (FDK)-based cone beam computed tomography (CBCT), and iterative CBCT. Subgroup analysis will be performed to determine patient alignment accuracy and toxicities rates with respect to different online daily imaging systems.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients undergo SBRT over 15-20 minutes every other day for a total of 5 treatments over 1-2 weeks in the absence of disease progression or unacceptable toxicity. Patients may receive androgen deprivation therapy for up to 18 months, as clinically indicated. Patients undergo positron emission tomography (PET) at screening and treatment failure, and blood sample collection throughout the study. Patients may also undergo magnetic resonance imaging (MRI) as clinically indicated at screening and treatment failure.
GROUP II: Patients undergo hypofractionated radiation therapy over 15-20 minutes once per day for a total of 20 treatments over 4-6 weeks in the absence of disease progression or unacceptable toxicity. Patients may receive androgen deprivation therapy for up to 18 months, as clinically indicated. Patients undergo PET at screening and treatment failure, and blood sample collection throughout the study. Patients may also undergo MRI as clinically indicated at screening and treatment failure.
After completion of study treatment, patients follow up at 3 months, 12 months, annually until year 5, and then optionally and per physician guidance every other year until death.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (SBRT) | Experimental | Drug: Antiandrogen Therapy, Procedure: Biospecimen Collection, Procedure: Positron Emission Tomography, Radiation: Stereotactic Body Radiation Therapy, Other: Survey Administration, Procedure: Magnetic Resonance ImagingPatients undergo SBRT over 15-20 minutes every other day for a total of 5 treatments over 1-2 weeks in the absence of disease progression or unacceptable toxicity. Patients may receive androgen deprivation therapy for up to 18 months, as clinically indicated. Patients undergo PET at screening and treatment failure, and blood sample collection throughout the study. Patients may also undergo MRI as clinically indicated at screening and treatment failure. |
| Group II (Hypofractionated radiation therapy) | Experimental | Drug: Antiandrogen Therapy, Procedure: Biospecimen Collection, Radiation: Hypofractionated Radiation Therapy, Procedure: Positron Emission Tomography, Other: Survey Administration, Procedure: Magnetic Resonance ImagingPatients undergo hypofractionated radiation therapy over 15-20 minutes once per day for a total of 20 treatments over 4-6 weeks in the absence of disease progression or unacceptable toxicity. Patients may receive androgen deprivation therapy for up to 18 months, as clinically indicated. Patients undergo PET at screening and treatment failure, and undergo blood sample collection throughout the study. Patients may also undergo MRI as clinically indicated at screening and treatment failure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed prostate adenocarcinoma at the time of surgery
- Pathologic stages T2-T3b, Nx or N0-1, M0-1 as staged by the pathology report (American Joint Committee on Cancer [AJCC] Criteria 8th edition [Ed.])
- PSA post radical prostatectomy ≥ 0.1 and < 2.0 ng/mL ≤ 90 days prior to enrollment, obtained ≥ 6 weeks after surgery
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 assessed ≤ 90 days of enrollment
- Patients must sign institutional review board (IRB) approved study specific informed consent
Key exclusion criteria (9 listed)
- Previous pelvic radiation
- Prior androgen deprivation therapy for prostate cancer and PSA ≥ 0.1 ng/mL
- 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 |
|---|---|---|
| Antiandrogen TherapyAlso: ADT, Androgen Deprivation Therapy, Androgen Deprivation Therapy (ADT), Anti-androgen TherapyReceive ADT | Drug | Group I (SBRT), Group II (Hypofractionated radiation therapy) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Group I (SBRT), Group II (Hypofractionated radiation therapy) |
| Hypofractionated Radiation TherapyAlso: Hypofractionated, Hypofractionated Radiotherapy, hypofractionation, Radiation, HypofractionatedUndergo hypofractionated radiation therapy | Radiation | Group II (Hypofractionated radiation therapy) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)Undergo PET scan | Procedure or surgery | Group I (SBRT), Group II (Hypofractionated radiation therapy) |
| Stereotactic Body Radiation TherapyAlso: SABR, SBRT, Stereotactic Ablative Body Radiation TherapyUndergo SBRT | Radiation | Group I (SBRT) |
| Survey AdministrationAncillary study | Other | Group I (SBRT), Group II (Hypofractionated radiation therapy) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging (MRI), MRI, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging ScanUndergo MRI | Procedure or surgery | Group I (SBRT), Group II (Hypofractionated radiation therapy) |
Primary outcome
Incidence of grade 3 or higher genitourinary (GU)/gastrointestinal (GI) radiation treatment-related adverse events
Time frame: Up to 2 years
Defined as the proportion of patients experiencing an increase in GU/GI Common Terminology Criteria for Adverse Events version 5.0 to grade 3+ compared to pre-radiation therapy GU/GI toxicity over the number of patients eligible for toxicity evaluation at 2 years from the start of radiation therapy. This endpoint will be compared between patients treated with stereotactic body radiation therapy and hypofractionated radiation therapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- 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, MD principal investigator
Mayo Clinic
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Antiandrogen Therapy, Biospecimen Collection and Hypofractionated Radiation Therapy in people with Biochemically Recurrent Prostate Carcinoma and Oligometastatic Prostate Carcinoma, run by Mayo Clinic at 6 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 9 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: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
Incidence of grade 3 or higher genitourinary (GU)/gastrointestinal (GI) radiation treatment-related adverse events (time frame: Up to 2 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 17 Sep 2026.