MDACC Study Summary 2003-0819 (Archived)

Study Summary
No. 2003-0819:.......Prostate......Andrew K. Lee......Radiation Oncology

Study Summary Title



Study Summary Number:	2003-0819

Study Title:	Randomized trial of external beam radiation with or without short-course hormonal therapy in intermediate risk prostate cancer patients

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:	713-792-5905 Contact us about clinical trials

General Information



Disease Group:	Prostate	Supported By:	N/A

Phase of Study:	Phase III	Return Visit:	Initial visit at three months post-radiation and then a minimum of six months for the initial two years and annually thereafter.

Treatment Agents:	Casodex Flutamide Goserelin Acetate Leuprolide Acetate 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 look at the medical benefit of adding hormone therapy to high-dose radiation therapy, compared to giving high-dose radiation therapy alone, in the treatment of prostate cancer.

Study Objectives / Outcomes

1. The primary objective will be to assess the possible improvement in PSA outcome of short course androgen suppression therapy in conjunction with dose-escalation intensity modulated radiation therapy (IMRT), 3D conformal radiation therapy (3D-CRT), or proton therapy over IMRT, 3D-CRT, or proton therapy alone in prostate cancer patients traditionally considered at intermediate risk for PSA failure following conventional local therapy. PSA failure will be the primary endpoint . Secondary objectives include local control, freedom from distant metastasis, and overall survival.
2. To study the impact of radiation therapy and/or hormone therapy on health-related quality of life measures using the Expanded Prostate Cancer Index Composite-Short Form 12-American Urological Association Symptom Index (EPIC-SF12-AUASI,http://roadrunner.cancer.med.umich.edu/epic/).
3. To assess prognostic value of pretreatment serum testoserone as well as the decrease in hemoglobin from neoadjuvant hormone therapy.
4. To assess prognostic value of pretreatment biomarkers on subsequent post-treatment clinical outcomes.

Study Status Information



Study Activation / Registration Date:	02/16/2005

IRB Review and Approval Date:	10/06/2004

Study Type:	Therapeutic

Recruitment Status:	Terminated

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) Biopsy proven prostate cancer within last 12 months. Pathology must be reviewed at MDACC.

2) 1992 AJCC clinical stage T1c-2b on digital rectal exam with biopsy Gleason sum of 7 and PSA <20 ng/mL (i.e. PSA 19.99 ng/mL or less), or

3) 1992 AJCC clinical stage T2b on physical exam with biopsy Gleason sum 7 or less and/or PSA <20 ng/ml, or

4) 1992 AJCC clinical stage T1c-2b on digital rectal exam with biopsy Gleason sum of 7 or less and PSA >10 but less than 20ng/ml (i.e. 10.01-19.99 ng/mL). PSA used for protocol eligibility should be obtained within 30 days of protocol enrollment.

5) No evidence of metastatic disease on bone scan within 3 months of study enrollment.

6) No evidence of metastatic disease on pelvic CT or MRI within 3 months of study enrollment.

7) Zubrod performance status < 2.

8) Must be able to understand protocol and adhere to follow-up initially at 3 months post-radiation and then at 6 month intervals for first two years and annually thereafter.

9) Patient must be able to undergo adequate daily trans-abdominal ultrasound localization (B.A.T.) or other image-guided localization of the prostate during radiation course.

10) Patients will be allowed to participate in other protocols if they are eligible and the other protocols do not interfere with participation in this protocol.

Exclusion Criteria:

1) Patients who do not meet the inclusion criteria. Specifically, patients with all the following features: clinical T1c-2a and Gleason sum 6 and PSA </=10 ng/ml. Patients with one or more of the following features: clinical T2c, or Gleason 8-10, or PSA > 20 ng/ml are not eligible.

2) Prior androgen suppression therapy. (Prior finasteride and saw palmetto allowed but must be discontinued prior to enrollment. Biopsy and PSA must be documented prior to finasteride use.)

3) Previous or concurrent malignancies other than basal or squamous cell skin cancers unless disease-free for 5 years or more.

4) Prior pelvic radiation or chemotherapy. Patients who received chemotherapy for non-prostate cancer malignancies over 5 years prior will be eligible.

5) Prior or planned radical prostate surgery.

6) Patients with clinical evidence or biopsy-proven extracapsular extension, seminal vesicle involvement, or lymph node involvement will be excluded. Patients with radiographic evidence of nodal or bone metastasis will be excluded.

7) Other histologies such as small cell carcinoma, sarcomatoid or ductal variants are not eligible.

8) Patients with any Gleason grade 5 disease on biopsy will not be eligible.

Links

Registration Number: NCT00388804
Study Information on Clinical Trials Registry (clinicaltrials.gov)