Hypofractionated Proton Beam Therapy for Localized Prostate Cancer

NCT01950351 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: 2012-1003NCI-2013-02347
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stage I Prostate Adenocarcinoma AJCC v7; Stage II Prostate Adenocarcinoma AJCC v7

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Rates of acute toxicity

  Within 90 days of treatment initiation

• Rate of late toxicity

  Up to 5 years post-treatment

• 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

  Baseline to up to 5 years

• Incidence of rising prostate-specific antigen (PSA)

  At 5 years

• Rate of local failure by biopsy

  Up to 5 years

Study Arms (1)

Treatment (proton beam radiation therapy)

EXPERIMENTAL

Patients undergo proton beam radiation therapy in 15 fractions over 5-6 weeks.

Other: Laboratory Biomarker Analysis; Radiation: Proton Beam Radiation Therapy; Other: Quality-of-Life Assessment

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (proton beam radiation therapy)

Proton Beam Radiation Therapy RADIATION

Undergo proton beam radiation therapy

Also known as: PBRT, Proton Radiation Therapy

Treatment (proton beam radiation therapy)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (proton beam radiation therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Interventions

Proton Therapy; Protons

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics; Cations, Monovalent; Cations; Ions; Electrolytes; Inorganic Chemicals; Hydrogen; Elements; Gases; Nucleons; Elementary Particles; Physical Phenomena

Study Officials

• Steven J Frank

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2013
• First Posted: September 25, 2013
• Study Start: October 10, 2013
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

US (1)