A Study to Evaluate Hypofractionated Proton Therapy or IMRT for Recurrent, Oligometastatic Prostate Cancer
NCT ID: NCT04190446
Last Updated: 2025-11-26
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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ACTIVE_NOT_RECRUITING
PHASE2
84 participants
INTERVENTIONAL
2020-01-06
2028-11-22
Brief Summary
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Detailed Description
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I. To assess late \>= grade 3 gastrointestinal (GI) and/or genitourinary (GU) toxicity of interest with the hypofractionated regimen with proton beam therapy or intensity-modulated radiation therapy (IMRT) (late defined as 3 to 24 months after protocol radiation therapy \[RT\]).
SECONDARY OBJECTIVES:
I. Late grade \>= 2 GI and/or GU toxicities of interest within 24 months after the protocol RT, using the Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0.
II. Acute grade \>= 3 GI and/or GU toxicities of interest during and within 3 months after the protocol RT, using the CTCAE v4.0.
III. Compare the rates of late \>= grade 3 GI and/or GU toxicity between the 2 treatment schedules.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo proton beam radiation therapy 5 days a week over 3 weeks. Patients undergo positron emission tomography (PET) scan, computed tomography (CT) scan, magnetic resonance imaging (MRI), and blood sample collection throughout the study.
ARM II: Patients undergo IMRT 5 days a week over 5 weeks. Patients undergo PET scan, CT scan, MRI, and blood sample collection throughout the study.
After completion of study, patients are followed up at 3-6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I (proton beam radiation therapy)
Patients undergo proton beam radiation therapy 5 days a week over 3 weeks. Patients undergo PET scan, CT scan, MRI, and blood sample collection throughout the study.
Proton Beam Radiation Therapy
Undergo proton beam radiation therapy
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Computed Tomography
Undergo CT scan
Magnetic Resonance Imaging
Undergo MRI
Biospecimen Collection
Undergo blood sample collection
Arm II (IMRT)
Patients undergo IMRT 5 days a week over 5 weeks. Patients undergo PET scan, CT scan, MRI, and blood sample collection throughout the study.
Intensity-Modulated Radiation Therapy
Undergo IMRT
Questionnaire Administration
Ancillary studies
Computed Tomography
Undergo CT scan
Magnetic Resonance Imaging
Undergo MRI
Biospecimen Collection
Undergo blood sample collection
Interventions
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Intensity-Modulated Radiation Therapy
Undergo IMRT
Proton Beam Radiation Therapy
Undergo proton beam radiation therapy
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Computed Tomography
Undergo CT scan
Magnetic Resonance Imaging
Undergo MRI
Biospecimen Collection
Undergo blood sample collection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histological confirmation of prostate adenocarcinoma
* Recurrent prostate cancer after prior receipt of primary radiotherapy to the prostate (can also include treatment of splenic vessels \[SVs\] and lymph nodes \[LNs\]) or salvage RT to the prostate fossa (can also include prior pelvic RT)
* Oligometastatic extent of disease
* Recurrent disease involving lymph nodes as diagnosed with choline positron emission tomography (PET)/computed tomography (CT) or other advanced PET imaging (prostate-specific membrane antigen \[PSMA\] or flucyclovine)
* Limited to pelvic and/or retroperitoneal/para-aortic lymph nodes
* Zubrod performance score (PS) =\< 1
* Signed informed consent
Exclusion Criteria
* Lymph node metastases beyond the pelvis and/or retroperitoneum
* Contraindications to RT (e.g., uncontrolled inflammatory bowel disease)
* Contraindications to androgen suppression
* Concurrent antineoplastic agents (chemotherapy)
* Previous or concurrent malignancy other than non-melanoma skin cancer within 5 years of diagnosis of prostate cancer
* Inability to start the radiation portion of the protocol treatment within 6 months after study enrollment
* Medical or psychiatric conditions that preclude informed decision-making or compliance with the protocol treatment or follow-up
18 Years
MALE
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Brian J. Davis, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2019-07705
Identifier Type: REGISTRY
Identifier Source: secondary_id
MC1851
Identifier Type: OTHER
Identifier Source: secondary_id
19-000708
Identifier Type: OTHER
Identifier Source: secondary_id
MC1851
Identifier Type: -
Identifier Source: org_study_id
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