Risk Stratified De-escalated Hormone Therapy With Radiation Therapy for the Treatment of Prostate Cancer
NCT ID: NCT06369610
Last Updated: 2025-11-14
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
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RECRUITING
PHASE2
110 participants
INTERVENTIONAL
2024-04-22
2027-04-22
Brief Summary
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Detailed Description
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I. Recovery of the Expanded Prostate Cancer Index Composite (EPIC) hormonal domain to baseline levels at 2-years.
EXPLORATORY OBJECTIVES:
I. After completion of radiation therapy, determine the incidence of:
Ia. Grade 2 or greater genitourinary (GU) and gastrointestinal (GI) toxicity at 6 months (Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0); Ib. Grade 3 or greater GU and GI toxicity at 6 months (CTCAE version 5.0); Ic. Patient-reported quality of life; Id. Impotence after the use of radiation therapy at 3 years; Ie. Freedom from biochemical failure (FFBF) at 5 years; If. Clinical failure: local and/or distant at 5 years; Ig. Salvage androgen deprivation use (SAD) at 5 years; Ih. Progression free survival: using clinical, biochemical and SAD as events at 5 years; Ij. Overall survival at 5 years; Ik. Disease-specific survival at 5 years. II. Determine overall GI and GU toxicity.
OUTLINE: Patients are assigned to 1 of 3 risk groups.
GROUP I (LOW RISK): Patients undergo radiation therapy to the prostate bed over 2 - 6 weeks.
GROUP II (INTERMEDIATE RISK): Patients receive ADT subcutaneously (SC) or intramuscularly (IM) for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy to the prostate bed over 2 - 6 weeks starting on week 8-10 of ADT hormone therapy.
GROUP III: (HIGH RISK): Patients receive ADT SC or IM with or without abiraterone acetate for up to 18 months in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy to identified areas over 2 - 6 weeks starting on week 8-10 of ADT hormone therapy.
Additionally, patients undergo positron emission tomography (PET), computed tomography (CT) or magnetic resonance imaging (MRI), and blood sample collection throughout the trial.
After completion of study treatment, patients are followed up at months 3 and 12, then yearly for up to year 5 followed by every 2 years.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group I (radiation therapy)
Patients undergo radiation therapy to the prostate bed over 2 - 6 weeks. Additionally, patients undergo PET, CT or MRI and blood sample collection throughout the study.
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT
Magnetic Resonance Imaging
Undergo MRI
Positron Emission Tomography
Undergo PET
Questionnaire Administration
Ancillary studies
Radiation Therapy
Undergo radiation therapy
Group II (ADT, radiation therapy)
Patients receive ADT SC or IM for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy to the prostate bed over 2 - 6 weeks starting on week 8-10 of ADT hormone therapy. Additionally, patients undergo PET, CT or MRI and blood sample collection throughout the study.
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT
Gonadotropin-releasing Hormone Analog
Given SC or IM
Magnetic Resonance Imaging
Undergo MRI
Positron Emission Tomography
Undergo PET
Questionnaire Administration
Ancillary studies
Radiation Therapy
Undergo radiation therapy
Group III (ADT, radiation therapy, abiraterone acetate)
Patients receive ADT SC or IM with or without abiraterone acetate for up to 18 months in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy to identified areas over 2 - 6 weeks starting on week 8-10 of ADT hormone therapy. Additionally, patients undergo PET, CT or MRI and blood sample collection throughout the study.
Abiraterone Acetate
Given abiraterone acetate
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT
Gonadotropin-releasing Hormone Analog
Given SC or IM
Magnetic Resonance Imaging
Undergo MRI
Positron Emission Tomography
Undergo PET
Questionnaire Administration
Ancillary studies
Radiation Therapy
Undergo radiation therapy
Interventions
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Abiraterone Acetate
Given abiraterone acetate
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT
Gonadotropin-releasing Hormone Analog
Given SC or IM
Magnetic Resonance Imaging
Undergo MRI
Positron Emission Tomography
Undergo PET
Questionnaire Administration
Ancillary studies
Radiation Therapy
Undergo radiation therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pathologic stages T1c-T4, N0-Nx-N1, M0-1 as staged by the pathology report (AJCC Criteria 8th Edition \[Ed\].)
* One or more high risk features including Gleason 8-10, T3-T4, prostate specific antigen (PSA) ≥ 20
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Patients must sign institutional review board (IRB) approved study specific informed consent
* Patients must complete all required pre-entry tests
* Patients must be at least 18 years old
* Oligometastatic prostate cancer defined as disease in up to 5 distant or regional areas (group 3 only)
Exclusion Criteria
* 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)
* 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
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Carlos E. Vargas, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Countries
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Central Contacts
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Facility Contacts
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Clinical Trials Referral Office
Role: primary
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2024-03020
Identifier Type: REGISTRY
Identifier Source: secondary_id
22-012591
Identifier Type: OTHER
Identifier Source: secondary_id
GMROA2256
Identifier Type: OTHER
Identifier Source: secondary_id
GMROA2256
Identifier Type: -
Identifier Source: org_study_id