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Hypofractionated Proton Beam Therapy for Localized Prostate Cancer

Primary Purpose

Stage I Prostate Adenocarcinoma AJCC v7, Stage II Prostate Adenocarcinoma AJCC v7

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Laboratory Biomarker Analysis

Proton Beam Radiation Therapy

Quality-of-Life Assessment

About this trial

This is an interventional treatment trial for Stage I Prostate Adenocarcinoma AJCC v7

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (proton beam radiation therapy)

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Rates of acute toxicity

Rates of acute toxicity will be assessed.

Rate of late toxicity

Rate of late toxicity will be determined.

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.

Incidence of rising prostate-specific antigen (PSA)

Incidence of rising PSA will be assessed.

Rate of local failure by biopsy

Rate of local failure by biopsy will be evaluated.

Full Information

NCT ID

NCT01950351

First Posted

September 23, 2013

Last Updated

October 4, 2023

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT01950351

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 10, 2013 (Actual)

Primary Completion Date

June 1, 2025 (Anticipated)

Study Completion Date

June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stage I Prostate Adenocarcinoma AJCC v7, Stage II Prostate Adenocarcinoma AJCC v7

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

241 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment (proton beam radiation therapy)

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Laboratory Biomarker Analysis

Intervention Description

Correlative studies

Intervention Type

Radiation

Intervention Name(s)

Proton Beam Radiation Therapy

Other Intervention Name(s)

PBRT, Proton Radiation Therapy

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

Primary Outcome Measure Information:

Title

Cumulative incidence of late grade 2 or greater gastrointestinal (GI) toxicity

Description

The cumulative incidence of late grade 2 or greater GI toxicity will be estimated with a 95% confidence interval.

Time Frame

Up to 2 years post-treatment

Secondary Outcome Measure Information:

Title

Rates of acute toxicity

Description

Rates of acute toxicity will be assessed.

Time Frame

Within 90 days of treatment initiation

Title

Rate of late toxicity

Description

Rate of late toxicity will be determined.

Time Frame

Up to 5 years post-treatment

Title

Description

Change in HRQOL will be evaluated.

Time Frame

Baseline to up to 5 years

Title

Incidence of rising prostate-specific antigen (PSA)

Description

Incidence of rising PSA will be assessed.

Time Frame

At 5 years

Title

Rate of local failure by biopsy

Description

Rate of local failure by biopsy will be evaluated.

Time Frame

Up to 5 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven J Frank

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

M D Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mdanderson.org

Description

University of Texas MD Anderson Cancer Center Website

Learn more about this trial

Hypofractionated Proton Beam Therapy for Localized Prostate Cancer

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