Metastatic Prostate Adenocarcinoma, Oligometastatic Prostate Carcinoma, Prostate Adenocarcinoma, Recurrent Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8
Conditions
Brief summary
This phase II trial studies the side effects of radiation therapy \[hypofractionated proton beam radiation therapy (PBRT) or intensity-modulated radiation therapy (IMRT)\] 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 PBRT 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 within each treatment arm, moderate hypofractionation (MHF) and conventional fractionation (CF), delivered with PBRT or 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 protocol treatment, using 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 treatment, using 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 IMRT or PBRT 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 or PBRT 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.
Interventions
RADIATIONIntensity-Modulated Radiation Therapy
Undergo IMRT
RADIATIONProton Beam Radiation Therapy
Undergo proton beam radiation therapy
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
PROCEDUREComputed Tomography
Undergo CT scan
PROCEDUREMagnetic Resonance Imaging
Undergo MRI
PROCEDUREBiospecimen Collection
Undergo blood sample collection
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male; age \>= 18 years * Histological confirmation of prostate adenocarcinoma * Recurrent prostate cancer after prior receipt of primary radiotherapy to the prostate \[can also include treatment of seminal vesicles (SVs) and lymph nodes (LNs)\] 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
* Bone or visceral metastases present at the time of treatment (consolidative radiotherapy allowed) * Lymph node metastases beyond the pelvis and/or retroperitoneum * Contraindications to RT (e.g., uncontrolled inflammatory bowel disease) * Contraindications to androgen suppression * Concurrent cytotoxic 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 protocol treatment. |
| 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 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBrian J. Davis, M.D.
Mayo Clinic in Rochester
Outcome results
None listed