MDACC Study Summary 2006-0038

Study Summary
No. 2006-0038:.......Prostate......Steven J. Frank......Radiation Oncology

Study Summary Title



Study Summary Number:	2006-0038

Study Title:	Transperineal Interstitial Permanent Brachytherapy Alone for Selected Patients with Intermediate Risk Prostatic Carcinoma

Physician

New Patient Referral



Name:	Steven J. Frank	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:	713-563-2300 Contact us about clinical trials

General Information



Disease Group:	Prostate	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Follow-up/Monitoring Plan:

Treatment Agents:	Radiation	Home Care:	n/a

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	n/a


Description/ Intervention:	The goal of this clinical research study is to learn if a prostate implant (brachytherapy) can help to control intermediate risk prostate cancer. The safety of this procedure will also be studied.

Study Objectives / Outcomes

Primary Objective

1. The primary goal of this study is to evaluate interstitial brachytherapy alone as related to biochemical (PSA) progression

Secondary Objectives

1. The secondary endpoints are to evaluate interstitial brachytherapy alone as related to: (a) overall survival, (b) disease-free survival, (c) disease-specific survival, (d) local progression, and (e) distant metastases.

2. To evaluate morbidity/quality of life with interstitial brachytherapy alone.

Study Status Information



Study Activation / Registration Date:	08/01/2006

IRB Review and Approval Date:	06/07/2006

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Open

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) Histologically confirmed adenocarcinoma of the prostate, clinical stage T1c - T2b (AJCC 6th Edition), N0, M0. Lymph node evaluation by either CT or MRI.

2) Zubrod performance status 0-1.

3) Patient must be greater than or equal to 18 years of age.

4) Patients with intermediate risk prostate cancer as determined by one of the following combinations: Gleason < 7, PSA 10-15; Gleason 7, PSA must be < 10.

5) Prostate specific antigen (PSA) prior to study entry must be less than or equal to 15 ng/ml.

6) Hormone naive.

7) Prostate volumes by TRUS less than or equal to 60 cc.

8) AUA voiding symptom scores </= 15 (alpha blockers allowed); this is completed by the patient.

9) Patients must sign a study-specific informed consent form prior to study entry.

Exclusion Criteria:

1) Stage < T1c, T2c, T3 or T4 disease (AJCC 6th Edition).

2) Lymph node involvement (N1).

3) Evidence of distant metastases (M1).

4) Radical surgery for carcinoma of the prostate, prior pelvic radiation, prior chemotherapy for prostate cancer, prior TURP, prior cryosurgery, TUNA, TUMT of the prostate.

5) Active prostatitis.

Links

Registration Number: NCT00525720
Study Information on Clinical Trials Registry (clinicaltrials.gov)