Hypofractionated Proton Beam Therapy for Localized Prostate Cancer

Stage II Prostate Adenocarcinoma AJCC v7 Clinical Trial

Official title:

Phase II Trial of Hypofractionated Proton Beam Therapy in Men With Localized Prostate Adenocarcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01950351
• Other study ID #: 2012-1003
• Secondary ID: NCI-2013-0234720
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 10, 2013
• Est. completion date: June 1, 2025

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 241
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostatic Neoplasms
• Stage I Prostate Adenocarcinoma AJCC v7
• Stage II Prostate Adenocarcinoma AJCC v7

Intervention

Other:
• Laboratory Biomarker Analysis
Correlative studies

Radiation:
• Proton Beam Radiation Therapy
Undergo proton beam radiation therapy

Other:
• Quality-of-Life Assessment
Ancillary studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence of late grade 2 or greater gastrointestinal (GI) toxicity	The cumulative incidence of late grade 2 or greater GI toxicity will be estimated with a 95% confidence interval.	Up to 2 years post-treatment
Secondary	Rates of acute toxicity	Rates of acute toxicity will be assessed.	Within 90 days of treatment initiation
Secondary	Rate of late toxicity	Rate of late toxicity will be determined.	Up to 5 years post-treatment
Secondary	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	Change in HRQOL will be evaluated.	Baseline to up to 5 years
Secondary	Incidence of rising prostate-specific antigen (PSA)	Incidence of rising PSA will be assessed.	At 5 years
Secondary	Rate of local failure by biopsy	Rate of local failure by biopsy will be evaluated.	Up to 5 years

External Links

•   University of Texas MD Anderson Cancer Center Website