Back to resultsRadiation Therapy (Hypofractionated Proton Beam Therapy or IMRT) for the Treatment of Recurrent, Oligometastatic Prostate Cancer Following Primary Localized Treatment
Primary Purpose
Metastatic Prostate Adenocarcinoma, Oligometastatic Prostate Carcinoma, Prostate Adenocarcinoma
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Intensity-Modulated Radiation Therapy
Proton Beam Radiation Therapy
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Prostate Adenocarcinoma
Eligibility Criteria
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 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:
- 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
Sites / Locations
- Mayo Clinic in RochesterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm I (proton beam radiation therapy)
Arm II (IMRT)
Arm Description
Patients undergo proton beam radiation therapy 5 days a week over 3 weeks.
Patients undergo IMRT 5 days a week over 5 weeks.
Outcomes
Primary Outcome Measures
Proportion of patients who experience a late (>= 90 days after radiation therapy [RT] start date) grade 3 or higher gastrointestinal (GI) and/or genitourinary (GU) adverse event (AE)
Toxicity will be defined as an adverse event possibly, probably, or definitely related to proton beam therapy. The proportion of grade 3 or higher GI or GU toxicities will be estimated by the number of patients with a late grade 3 or higher GI or GU toxicity divided by the total number of evaluable patients. Exact binomial 90% confidence intervals for the toxicity proportion will be calculated.
Secondary Outcome Measures
Incidence of acute adverse events
The rate of >= grade 3 GI or GU acute adverse events will be estimated by the number of patients with a >= grade 3 GI or GU acute adverse event divided by the total number of evaluable patients. Exact binomial 90% confidence intervals for the true rate of >= grade 3 GI or GU acute adverse events will be calculated.
Incidence of late adverse events
The rate of >= grade 2 GI or GU late adverse events will be estimated by the number of patients with a >= grade 2 GI or GU late adverse event divided by the total number of evaluable patients. Exact binomial 90% confidence intervals for the true rate of >= grade 2 GI or GU late adverse events will be calculated.
Proportion of grade 3 or higher GI or GU adverse events
The difference between the 2 treatment arm proportions will be determined and exact binomial 90% confidence intervals for the difference in grade 3 or higher GI or GU toxicity rates will be calculated.
Incidence of adverse events
All eligible patients that have initiated treatment will be considered evaluable for assessing adverse event rate(s). The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. Acute and late adverse events will be summarized separately.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04190446
Brief Title
Radiation Therapy (Hypofractionated Proton Beam Therapy or IMRT) for the Treatment of Recurrent, Oligometastatic Prostate Cancer Following Primary Localized Treatment
Official Title
A Randomized, Parallel Phase II Trial of Hypofractionated Proton Therapy or IMRT for Recurrent, Oligometastatic Prostate Cancer Involving Only Pelvic and/or Para-Aortic Lymph Nodes Following Primary Localized Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 6, 2020 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
ARM II: Patients undergo IMRT 5 days a week over 5 weeks.
After completion of study, patients are followed up at 3-6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Prostate Adenocarcinoma, Oligometastatic Prostate Carcinoma, Prostate Adenocarcinoma, Recurrent Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
83 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm I (proton beam radiation therapy)
Arm Type
Experimental
Arm Description
Patients undergo proton beam radiation therapy 5 days a week over 3 weeks.
Arm Title
Arm II (IMRT)
Arm Type
Experimental
Arm Description
Patients undergo IMRT 5 days a week over 5 weeks.
Intervention Type
Radiation
Intervention Name(s)
Intensity-Modulated Radiation Therapy
Other Intervention Name(s)
IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated Radiotherapy
Intervention Description
Undergo IMRT
Intervention Type
Radiation
Intervention Name(s)
Proton Beam Radiation Therapy
Other Intervention Name(s)
PBRT, Proton, Proton EBRT, Proton External Beam Radiotherapy, Proton Radiation Therapy, Radiation, Proton Beam
Intervention Description
Undergo proton beam radiation therapy
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Proportion of patients who experience a late (>= 90 days after radiation therapy [RT] start date) grade 3 or higher gastrointestinal (GI) and/or genitourinary (GU) adverse event (AE)
Description
Toxicity will be defined as an adverse event possibly, probably, or definitely related to proton beam therapy. The proportion of grade 3 or higher GI or GU toxicities will be estimated by the number of patients with a late grade 3 or higher GI or GU toxicity divided by the total number of evaluable patients. Exact binomial 90% confidence intervals for the toxicity proportion will be calculated.
Time Frame
Up to 24 months after RT
Secondary Outcome Measure Information:
Title
Incidence of acute adverse events
Description
The rate of >= grade 3 GI or GU acute adverse events will be estimated by the number of patients with a >= grade 3 GI or GU acute adverse event divided by the total number of evaluable patients. Exact binomial 90% confidence intervals for the true rate of >= grade 3 GI or GU acute adverse events will be calculated.
Time Frame
Up to 3 months after the completion of RT
Title
Incidence of late adverse events
Description
The rate of >= grade 2 GI or GU late adverse events will be estimated by the number of patients with a >= grade 2 GI or GU late adverse event divided by the total number of evaluable patients. Exact binomial 90% confidence intervals for the true rate of >= grade 2 GI or GU late adverse events will be calculated.
Time Frame
Between 3 months and 2 years after completion of proton beam therapy
Title
Proportion of grade 3 or higher GI or GU adverse events
Description
The difference between the 2 treatment arm proportions will be determined and exact binomial 90% confidence intervals for the difference in grade 3 or higher GI or GU toxicity rates will be calculated.
Time Frame
Up to 60 months
Title
Incidence of adverse events
Description
All eligible patients that have initiated treatment will be considered evaluable for assessing adverse event rate(s). The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. Acute and late adverse events will be summarized separately.
Time Frame
Up to 60 months
Other Pre-specified Outcome Measures:
Title
Expanded Prostate Cancer Index Composite short form (EPIC-26) questionnaire
Description
Subdomains for urinary, bowel, and sexual function will be evaluated at each time point and summarized descriptively. Changes across time will be evaluated to assess patient function and quality of life after study treatment.
Time Frame
Up to 60 months
Title
Disease-free survival
Description
The distribution of disease-free survival will be estimated using the method of Kaplan-Meier.
Time Frame
From registration until the time of the first occurrence of biochemical failure, local recurrence, regional recurrence, distant metastases, or death due to any cause, assessed at 2 and 5 years
Title
Disease-specific survival
Description
The distribution of disease-specific survival will be estimated using the method of Kaplan-Meier.
Time Frame
From registration until the date of death due to prostate cancer, assessed up to 2 and 5 years
Title
Overall survival
Description
The distribution of overall survival will be estimated using the method of Kaplan-Meier.
Time Frame
From registration until the death due to any cause, assessed at 2 and 5 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian J Davis
Organizational Affiliation
Mayo Clinic in Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Brian J. Davis, M.D.
12. IPD Sharing Statement
Learn more about this trial
Radiation Therapy (Hypofractionated Proton Beam Therapy or IMRT) for the Treatment of Recurrent, Oligometastatic Prostate Cancer Following Primary Localized Treatment
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