Description:
This phase II trial studies the side effects and how well hypofractionated proton beam
radiation therapy works in treating patients with prostate cancer that has not spread to
nearby lymph nodes or to other parts of the body. Specialized radiation therapy, such as
proton beam radiation therapy, that delivers a high dose of radiation directly to the tumor
may kill more tumor cells and cause less damage to normal tissue.
Title
- Brief Title: Hypofractionated Proton Beam Therapy for Localized Prostate Cancer
- Official Title: Phase II Trial of Hypofractionated Proton Beam Therapy in Men With Localized Prostate Adenocarcinoma
Clinical Trial IDs
- ORG STUDY ID:
2012-1003
- SECONDARY ID:
NCI-2013-02347
- SECONDARY ID:
2012-1003
- NCT ID:
NCT01950351
Conditions
- Stage I Prostate Adenocarcinoma AJCC v7
- Stage II Prostate Adenocarcinoma AJCC v7
Purpose
This phase II trial studies the side effects and how well hypofractionated proton beam
radiation therapy works in treating patients with prostate cancer that has not spread to
nearby lymph nodes or to other parts of the body. Specialized radiation therapy, such as
proton beam radiation therapy, that delivers a high dose of radiation directly to the tumor
may kill more tumor cells and cause less damage to normal tissue.
Detailed Description
PRIMARY OBJECTIVES:
I. Estimate the incidence of grade 2 gastrointestinal toxicity following the proposed
treatment regimens at 2 years post-treatment.
SECONDARY OBJECTIVES:
I. Estimate the change in health related quality of life (HRQOL) following the proposed
treatment regimen compared to pre-treatment assessment as defined by Expanded Prostate Cancer
Index Composite (EPIC), Utilization of Sexual Medications/Devices, and Medical
history/conditions questionnaire.
II. Estimate the rates of acute toxicity of the treatment regimens. III. Estimate the rates
of late toxicity at 3, 4, and 5 years post-treatment. IV. Assess the efficacy of
hypo-fractionated proton beam therapy, defined by the incidence of a rising prostate-specific
antigen (PSA) at 5 years.
V. Determine the rate of local failure by biopsy of the prostate when objective tests,
prostate-specific antigen (PSA), magnetic resonance imaging (MRI), digital rectal exam (DRE),
suggest relapse.
OUTLINE:
Patients undergo proton beam radiation therapy in 15 fractions over 5-6 weeks.
After completion of study treatment, patients are followed up every 6-12 months for 24 months
and then annually until month 60.
Trial Arms
Name | Type | Description | Interventions |
---|
Treatment (proton beam radiation therapy) | Experimental | Patients undergo proton beam radiation therapy in 15 fractions over 5-6 weeks. | |
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed diagnosis of adenocarcinoma of the prostate within one year
of study entry; evaluation can happen outside of MD Anderson as long as histological
confirmation takes place at MD Anderson
- History/physical examination with digital rectal examination of the prostate within 90
days prior to registration
- Histological evaluation of prostate biopsy with assignment of a Gleason score to the
biopsy material demonstrating Gleason score 2-7 within 365 days of registration
- Clinical stage T1-2b (American Joint Committee on Cancer [AJCC] 7th edition) and PSA <
20 ng/mL within 90 days prior to registration; PSA should not be obtained within 10
days after prostate biopsy
- Zubrod performance status 0-1 within 90 days prior to registration
- Patient must be able to provide study-specific informed consent prior to study entry
- Willingness and ability to complete the EPIC questionnaire
Exclusion Criteria:
- Prior or concurrent invasive malignancy (except non-melanomatous skin cancer or
lymphomatous/hematogenous malignancy) unless continually disease free for a minimum of
5 years
- Evidence of distant metastases
- Regional lymph node involvement
- Previous prostatectomy, cryosurgery, or high intensity focused ultrasound (HIFU) for
prostate cancer
- Previous pelvic radiation or prostate brachytherapy
- Active and severe medical co-morbidity defined as follows: unstable angina and/or
congestive heart failure requiring hospitalization within the last 6 months,
transmural myocardial infarction within the last 6 months, acute bacterial or fungal
infection requiring intravenous antibiotics at the time of registration, chronic
obstructive pulmonary disease exacerbation or other respiratory illness requiring
hospitalization or precluding study therapy at the time of registration, hepatic
insufficiency resulting in clinical jaundice, active inflammatory bowel disease
(Crohn's disease or ulcerative colitis), diagnosed connective tissue disorder, or
congenital coagulation defects (patients on medical therapy with Coumadin or other
blood thinning agents are eligible for participation)
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Cumulative incidence of late grade 2 or greater gastrointestinal (GI) toxicity |
Time Frame: | Up to 2 years post-treatment |
Safety Issue: | |
Description: | The cumulative incidence of late grade 2 or greater GI toxicity will be estimated with a 95% confidence interval. |
Secondary Outcome Measures
Measure: | Rates of acute toxicity |
Time Frame: | Within 90 days of treatment initiation |
Safety Issue: | |
Description: | Rates of acute toxicity will be assessed. |
Measure: | Rate of late toxicity |
Time Frame: | Up to 5 years post-treatment |
Safety Issue: | |
Description: | Rate of late toxicity will be determined. |
Measure: | Change in health related quality of life (HRQOL) as assessed by the Expanded Prostate Cancer Index Composite (EPIC) Utilization of Sexual Medications/Devices, and Medical history/conditions questionnaire |
Time Frame: | Baseline to up to 5 years |
Safety Issue: | |
Description: | Change in HRQOL will be evaluated. |
Measure: | Incidence of rising prostate-specific antigen (PSA) |
Time Frame: | At 5 years |
Safety Issue: | |
Description: | Incidence of rising PSA will be assessed. |
Measure: | Rate of local failure by biopsy |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | Rate of local failure by biopsy will be evaluated. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | M.D. Anderson Cancer Center |
Last Updated
July 22, 2020