MDACC Study Summary 2005-0956

Study Summary
No. 2005-0956:.......Prostate......Andrew K. Lee......Radiation Oncology

Study Summary Title



Study Summary Number:	2005-0956

Study Title:	Prospective evaluation of quality of life after proton therapy for prostate cancer

Physician

New Patient Referral



Name:	Andrew K. Lee	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Radiation Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-563-2348 Contact us about clinical trials

General Information



Disease Group:	Prostate	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Patients should return to M.D. Anderson at three months after their treatment and subsequently thereafter at the discretion of the treating physician.

Treatment Agents:	Casodex Flutamide Goserelin Acetate Leuprolide Acetate Radiation	Home Care:	N/A

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	NA

Description/
Intervention:

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.

Study Objectives / Outcomes

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:

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

Study Status Information



Study Activation / Registration Date:	05/24/2006

IRB Review and Approval Date:	04/27/2006

Study Type:	Observational

Recruitment Status:	Closed

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

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

2) 1992 AJCC clinical stage T1-T3c on digital rectal exam.

3) PSA within 4 weeks of study entry.

4) Zubrod performance status of 0-1 with a life expectancy of at least 10 years.

5) Prior hormonal therapy allowed if began no more than three months prior to registration.

6) Patient must be able to adhere to follow-up schedule either personally or via mail or phone.

7) Patient must be able to speak, read and understand English.

8) Patient must give informed consent.

Exclusion Criteria:

1) Histology other than adenocarcinoma.

2) Evidence of distant or nodal metastasis.

3) Prior pelvic radiotherapy or chemotherapy.

4) Prior or planned radical prostate surgery.

5) Prior local therapy for prostate cancer.

6) 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.

7) History of inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis).

8) Patients with metallic devices in the hip/pelvis (e.g. hip prostheses) that may interfere with proton dosimetry will not be eligible.

Links

Registration Number: NCT00489814
Study Information on Clinical Trials Registry (clinicaltrials.gov)