A Study to Evaluate Hypofractionated Proton Therapy or IMRT for Recurrent, Oligometastatic Prostate Cancer
- Conditions
- Metastatic Prostate AdenocarcinomaOligometastatic Prostate CarcinomaProstate AdenocarcinomaRecurrent Prostate CarcinomaStage IV Prostate Cancer AJCC v8
- Interventions
- Radiation: Intensity-Modulated Radiation TherapyRadiation: Proton Beam Radiation TherapyOther: Quality-of-Life AssessmentProcedure: Computed TomographyOther: Questionnaire AdministrationProcedure: Magnetic Resonance ImagingProcedure: Biospecimen Collection
- Registration Number
- NCT04190446
- Lead Sponsor
- Mayo Clinic
- Brief Summary
This phase II trial studies the side effects of radiation therapy (hypofractionated proton beam therapy or IMRT) for the treatment of prostate cancer that has come back (recurrent) or that has spread to a limited number of sites (oligometastatic) following primary localized treatment. Hypofractionated proton beam radiation therapy delivers smaller doses of radiation therapy over time and may kill more tumor cells and have fewer side effects. IMRT uses high energy x-rays to kill tumor cells and shrink tumors. This trial is being done to find out if a shorter course of radiation therapy is better with fewer side effects for patients with recurrent prostate cancer.
- Detailed Description
PRIMARY OBJECTIVE:
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 84
-
Male; age >= 18 years
-
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
- Bone or visceral metastases present
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I (proton beam radiation therapy) Magnetic Resonance Imaging 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. Arm II (IMRT) Intensity-Modulated Radiation Therapy Patients undergo IMRT 5 days a week over 5 weeks. Patients undergo PET scan, CT scan, MRI, and blood sample collection throughout the study. Arm II (IMRT) Biospecimen Collection Patients undergo IMRT 5 days a week over 5 weeks. Patients undergo PET scan, CT scan, MRI, and blood sample collection throughout the study. Arm I (proton beam radiation therapy) 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. Arm II (IMRT) Computed Tomography Patients undergo IMRT 5 days a week over 5 weeks. Patients undergo PET scan, CT scan, MRI, and blood sample collection throughout the study. Arm I (proton beam radiation therapy) Quality-of-Life Assessment 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. Arm I (proton beam radiation therapy) Questionnaire Administration 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. Arm II (IMRT) Magnetic Resonance Imaging Patients undergo IMRT 5 days a week over 5 weeks. Patients undergo PET scan, CT scan, MRI, and blood sample collection throughout the study. Arm I (proton beam radiation therapy) Computed Tomography 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. Arm I (proton beam radiation therapy) Biospecimen Collection 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. Arm II (IMRT) Questionnaire Administration Patients undergo IMRT 5 days a week over 5 weeks. Patients undergo PET scan, CT scan, MRI, and blood sample collection throughout the study.
- Primary Outcome Measures
Name Time Method Incidence of late > grade 3 GI and/or GU toxicity Up to 24 months after RT Assessed by the number of patients who experience a late (≥ 90 days after RT start date) grade 3 or higher gastrointestinal (GI) and/or genitourinary (GU) adverse event (AE) defined as possibly, probably, or definitely related to radiation therapy (RT). Adverse events will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
- Secondary Outcome Measures
Name Time Method Incidence of acute adverse events Up to 3 months after the completion of RT Assessed by the number of patients with \>= grade 3 GI or GU acute adverse events. Acute AEs are defined as those that occur from day 1, or commencement of RT, through 3 months after the completion of protocol treatment.
Incidence of late adverse events Between 3 months and 2 years after completion of proton beam therapy Assessed by the number of ≥ grade 2 GI or GU late adverse events per CTCAE v 4.0 will be recorded. A late AE is defined as an adverse event that occurs any time between 3 months and 2 years after completion of proton beam therapy.
Incidence of grade 3 or higher GI or GU adverse events per treatment schedule Up to 60 months Assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Rates of late ≥ grade 3 GI and/or GU toxicity will be compared between the treatment schedules.
Incidence of adverse events Incidence of adverse events Incidence of adverse events Up to 60 months Assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The maximum grade for each type of adverse event will be recorded for each patient.
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States