Study of Quality of Life for Prostate Proton Therapy

Status unconfirmed

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00489814

Run by

M.D. Anderson Cancer Center

People needed

1125

Starts

2006-05-24

Expected to finish

2020-05-24

Last updated by the study team

2020-01-07

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

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.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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