Study of Quality of Life for Prostate Proton Therapy

NCT00489814 | Unknown

• 1 other identifier: 2005-0956
• Study Type: observational
• Target: 1,125
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this research study is 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. Information on your treatment and how you react to the treatment will be collected. Researchers will use this information to try to understand how people tolerate proton radiation therapy for prostate cancer.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Prostate Proton Therapy; Proton Radiation Therapy; Proton Radiotherapy; Quality of Life; QOL; Questionnaire

Outcome Measures

Primary Outcomes (1)

• 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.

  4 Years

Study Arms (1)

1

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

Behavioral: Questionnaire

Interventions

Questionnaire BEHAVIORAL

Questionnaires administered within 3 weeks before the beginning of the radiation treatment course, twice during radiation therapy, and upon completion of radiation therapy.

Also known as: Survey

1

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Patients who are planned to undergo local proton radiotherapy for biopsy-proven, untreated, prostate adenocarcinoma with Gleason scoring.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Seungtaek Choi, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2007
• First Posted: June 21, 2007
• Study Start: May 24, 2006
• Primary Completion: May 24, 2020
• Study Completion: May 24, 2020
• Last Updated: January 7, 2020

Record last verified: 2020-01

Locations

US (1)