Radiation Therapy and Hormone Therapy in Treating Patients With Prostate Cancer

NCT ID: NCT00769548

Last Updated: 2017-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1322 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1995-04-30
• Study Completion Date: 2016-12-31

Brief Summary

RATIONALE: Radiation therapy uses high energy x-rays to damage tumor cells. Hormone therapy combined with radiation therapy may be a more effective treatment for prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of four different combinations of radiation and hormone therapy in treating patients with prostate cancer.

Detailed Description

OBJECTIVES: I. Examine whether total androgen suppression (TAS) with flutamide/goserelin and whole-pelvic irradiation followed by a cone-down boost to the prostate improves progression-free survival at 5 years by at least 10% compared to TAS and prostate-only irradiation in patients with adenocarcinoma of the prostate at significant risk of nodal involvement. II. Examine whether induction and concurrent (neoadjuvant) TAS and radiotherapy improves the progression-free survival at 5 years by at least 10% compared to adjuvant TAS and radiotherapy. III. Compare treatments with regard to local control, time to distant failure, and overall survival.

OUTLINE: Randomized study. Arm I: Neoadjuvant Antiandrogen Therapy with Radiotherapy. Flutamide, FLUT, NSC-147834; Goserelin, Zoladex, ZDX, NSC-606864; with irradiation of the whole pelvis followed by a boost to the prostate using photons of at least 6 MV. Arm II: Neoadjuvant Antiandrogen Therapy with Radiotherapy; FLUT; ZDX; with irradiation of the prostate using equipment as in Arm I. Arm III: Radiotherapy followed by Adjuvant Antiandrogen Therapy. Irradiation as in Arm I; followed by FLUT; ZDX. Arm IV: Radiotherapy followed by Adjuvant Antiandrogen Therapy. Irradiation as in Arm II; followed by FLUT; ZDX.

PROJECTED ACCRUAL: 1,200 patients will be accrued over 2.5 years.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Neoadjuvant total androgen suppression (TAS) given 2 months before and during radiation therapy (RT) to the whole pelvis followed by a prostate boost.

Group Type: EXPERIMENTAL

flutamide

Intervention Type: DRUG

Drug used for TAS.

goserelin acetate

Intervention Type: DRUG

Drug used for TAS.

low-LET photon therapy

Intervention Type: RADIATION

radiation therapy

Arm 2

Neoadjuvant TAS given 2 months before and during RT to the prostate only.

Group Type: EXPERIMENTAL

flutamide

Intervention Type: DRUG

Drug used for TAS.

goserelin acetate

Intervention Type: DRUG

Drug used for TAS.

low-LET photon therapy

Intervention Type: RADIATION

radiation therapy

Arm 3

RT to the whole pelvis followed by a boost to the prostate followed by 4 months of TAS.

Group Type: EXPERIMENTAL

flutamide

Intervention Type: DRUG

Drug used for TAS.

goserelin acetate

Intervention Type: DRUG

Drug used for TAS.

low-LET photon therapy

Intervention Type: RADIATION

radiation therapy

Arm 4

RT to the prostate only followed by 4 months of TAS.

Group Type: EXPERIMENTAL

flutamide

Intervention Type: DRUG

Drug used for TAS.

goserelin acetate

Intervention Type: DRUG

Drug used for TAS.

low-LET photon therapy

Intervention Type: RADIATION

radiation therapy

Interventions

flutamide

Drug used for TAS.

Intervention Type: DRUG

goserelin acetate

Drug used for TAS.

Intervention Type: DRUG

low-LET photon therapy

radiation therapy

Intervention Type: RADIATION

Other Intervention Names

radiation therapy

Eligibility Criteria

Inclusion Criteria

PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 70-100% Hematopoietic: Not specified Hepatic: Liver function tests no greater than 1.2 times normal Renal: Not specified Other: No major medical or psychiatric illness that would prevent completion of treatment or interfere with follow-up No second malignancy within 5 years except superficial nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: At least 90 days since testosterone At least 60 days since finasteride Radiotherapy: No prior radiotherapy Surgery: No more than 60 days since surgical staging No radical surgery or cryosurgery

• Maximum Eligible Age: 120 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Radiation Therapy Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mack Roach, MD

Role: STUDY_CHAIR

University of California, San Francisco

References

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Reference Type: BACKGROUND

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Other Identifiers

CDR0000063822

Identifier Type: -

Identifier Source: secondary_id

RTOG-9413

Identifier Type: -

Identifier Source: org_study_id