Study of Quality of Life for Prostate Proton Therapy - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00489814

Purpose

Primary Objective:

-Estimate the incidence of acute and late side effects of proton radiation therapy for prostate cancer including the development of second malignancies.

Secondary Objectives:

Estimate the health-related-quality of life of prostate cancer patients following proton radiation therapy.
Correlate dosimetric parameters of normal tissue to subsequent side-effects.

Condition	Intervention
Prostate Cancer	Behavioral: Questionnaire

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Prospective Evaluation of Quality of Life After Proton Therapy for Prostate Cancer

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To collect information on the side effects of proton radiation therapy given for the treatment of prostate cancer as well as the effect of proton therapy on quality of life. [ Time Frame: 4 Years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	600
Study Start Date:	May 2006
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Patients who are planned to undergo local proton radiotherapy for biopsy-proven, untreated, prostate adenocarcinoma.	Behavioral: Questionnaire Questionnaires administered within 3 weeks before the beginning of the radiation treatment course, twice during radiation therapy, and upon completion of radiation therapy.

Detailed Description:

Prostate cancer tends to be better controlled with higher doses of radiation. These high doses may lead to more side effects. Standard radiation therapy uses x-rays, which are effective but may cause extra radiation dose to be given to tissues beyond the tumor, such as the rectum and bladder. Unlike x-rays, protons (small positively-charged particles) can deliver radiation dose to a specific target but then suddenly deliver much less dose beyond the target. This minimizes the dose to normal tissues and may lead to fewer side effects, even when high doses are delivered to the tumor.

If you agree to take part in this study, it will involve completing quality of life questionnaires before, during, and after proton therapy. You will be asked how you tolerated the proton therapy, what (if any) side effects you experienced, and how the treatment impacts the quality of your life. The questionnaires should each take about 15 minutes to complete. They may be done in person, by mail, or by phone.

You will complete the questionnaires before the proton therapy begins, and twice during the therapy (mid-way through therapy and during the last week of therapy). You will also repeat the questionnaires at 3, 6, 9, and 12 months after the proton therapy, every 6 months for the next 3 years, and every year for the next 6 years after that. If you are receiving hormone therapy, you will also be asked to fill out a questionnaire before or at the beginning of hormone therapy. During your radiation course, you will have a brief weekly clinic visit and assessed for any side effects during that visit as part of normal standard practice. Your information will be compiled with the information from other people who were treated similarly, to better understand the effects of prostate proton radiation therapy.

Throughout the course of your radiation therapy, you will have brief clinic visits once a week as part of your standard care. You will be checked for any side effects.

Your participation in the study will be over after you mail back the last questionnaire.

This is an investigational study. Up to 600 patients will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Study participants who are planned to undergo local proton radiotherapy for biopsy-proven, untreated, prostate adenocarcinoma.

Criteria

Inclusion Criteria:

Patients who are planned to undergo local proton radiotherapy for biopsy-proven, untreated, prostate adenocarcinoma with Gleason scoring.
1992 AJCC clinical stage T1-T3c on digital rectal exam.
PSA within 4 weeks of study entry.
Zubrod performance status of 0-1 with a life expectancy of at least 10 years.
Prior hormonal therapy allowed if began no more than three months prior to registration.
Patient must be able to adhere to follow-up schedule either personally or via mail or phone.
Patient must be able to speak, read, and understand English.
Patient must give informed consent.

Exclusion Criteria:

Histology other than adenocarcinoma.
Evidence of distant or nodal metastasis.
Prior pelvic radiotherapy or chemotherapy.
Prior or planned radical prostate surgery.
Prior local therapy for prostate cancer.
Previous and/or concurrent malignancy unless disease free for > 5 years. Basal cell and non-invasive squamous cell carcinoma of the skin will not exclude patient from eligibility.
History of inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis).
Patients with metallic devices in the hip/pelvis (e.g. hip prostheses) that may interfere with proton dosimetry will not be eligible.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00489814

Contacts

Contact: Andrew K. Lee, MD

713-563-2348

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Andrew K. Lee, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Andrew K. Lee, MD

U.T.M.D. Anderson Cancer Center

More Information

UT MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	U.T. M.D. Anderson Cancer Center ( Andrew K. Lee, MD/Assoc. Professor )
Study ID Numbers:	2005-0956
Study First Received:	June 19, 2007
Last Updated:	December 29, 2008
ClinicalTrials.gov Identifier:	NCT00489814
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Prostate Cancer
Prostate Proton Therapy
Proton Radiation Therapy
Proton Radiotherapy

Quality of Life
QOL
Questionnaire

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Quality of Life

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009