SBRT Versus Hypofractionated Radiotherapy for Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma
NCT ID: NCT06205316
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
118 participants
INTERVENTIONAL
2024-01-22
2030-01-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Stereotactic Body Radiation Therapy in Treating Patients With Localized Prostate Cancer That Have Undergone Surgery
NCT03541850
Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy
NCT03253744
Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Prostate Cancer Undergoing Surgery
NCT02830165
Adaptive Radiation Therapy (ART) Stereotactic Ablative Body Radiotherapy (SABR) for Primary Localized Prostate Cancer
NCT06325046
SBRT for Oligometastatic Castration-Refractory Prostate Cancer
NCT02816983
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
I. 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:
I. 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.
X. 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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group I (SBRT)
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.
Antiandrogen Therapy
Receive ADT
Biospecimen Collection
Undergo blood sample collection
Positron Emission Tomography
Undergo PET scan
Stereotactic Body Radiation Therapy
Undergo SBRT
Survey Administration
Ancillary study
Magnetic Resonance Imaging
Undergo MRI
Group II (Hypofractionated radiation therapy)
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.
Antiandrogen Therapy
Receive ADT
Biospecimen Collection
Undergo blood sample collection
Hypofractionated Radiation Therapy
Undergo hypofractionated radiation therapy
Positron Emission Tomography
Undergo PET scan
Survey Administration
Ancillary study
Magnetic Resonance Imaging
Undergo MRI
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Antiandrogen Therapy
Receive ADT
Biospecimen Collection
Undergo blood sample collection
Hypofractionated Radiation Therapy
Undergo hypofractionated radiation therapy
Positron Emission Tomography
Undergo PET scan
Stereotactic Body Radiation Therapy
Undergo SBRT
Survey Administration
Ancillary study
Magnetic Resonance Imaging
Undergo MRI
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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)
* 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
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mayo Clinic
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Carlos E. Vargas, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, United States
Mayo Clinic Health System - Mankato
Mankato, Minnesota, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin, United States
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Related Links
Access external resources that provide additional context or updates about the study.
Mayo Clinic Clinical Trials
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2023-10897
Identifier Type: REGISTRY
Identifier Source: secondary_id
22-009244
Identifier Type: OTHER
Identifier Source: secondary_id
GMROA2255
Identifier Type: OTHER
Identifier Source: secondary_id
GMROA2255
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.