Combination Hormone Therapy Followed by Radiation Therapy in Treating Patients With Prostate Cancer

Sponsor

St. Luke's Hospital, Ireland (Other)

Overall Status

Unknown status

CT.gov ID

NCT00003734

Collaborator

(none)

276

Enrollment

Locations

Patients Per Site

Study Details

Study Description

Brief Summary

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using triptorelin and flutamide may fight cancer by reducing the production of androgens. It is not yet known whether giving hormone therapy for 4 months is more effective than giving therapy for 8 months prior to radiation therapy for prostate cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of combination hormone therapy for 4 or 8 months followed by radiation therapy in treating patients with prostate cancer.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: flutamide Drug: triptorelin Radiation: radiation therapy	Phase 3

Detailed Description

OBJECTIVES: I. Compare the efficacy of 4 months vs 8 months of luteinizing hormone-releasing hormone (LHRH) agonist therapy combined with antiandrogen therapy prior to radiotherapy, in terms of disease-free survival and overall survival, in patients with stage I-IV localized invasive prostate cancer.

OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. All patients receive triptorelin IM once a month and oral flutamide three times daily with meals. Patients randomized to arm I receive this therapy regimen for 4 months. Patients randomized to arm II receive this therapy regimen for 8 months. All patients then undergo radiotherapy 5 days a week for 7 weeks within 2 months of the last injection of triptorelin and within 1 month of the last oral flutamide tablet. Patients are followed every 3 months after radiotherapy.

PROJECTED ACCRUAL: A total of 276 patients (138 per treatment arm) will be accrued for this study.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

276 participants

Allocation:

Randomized

Primary Purpose:

Treatment

Official Title:

A Randomised Comparison of Short and Protracted Neoadjuvant Hormonal Therapy Prior to Radiation Therapy of High Risk Localized Prostate Cancer

Study Start Date :

Dec 1, 1998

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS: Histologically confirmed invasive adenocarcinoma of the prostate Stage I or II (PSA greater than 20 or Gleason score at least 7) OR Stage III or IV (any PSA, any Gleason) Histologically confirmed benign nodal status No distant metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other prior malignancy except nonmelanoma skin cancer No other uncontrolled illness that would prevent compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: No prior or other concurrent hormonal therapy Radiotherapy: Not specified Surgery: No prior treatment other than transurethral prostatectomy No prior orchiectomy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cork University Hospital	Cork		Ireland
2	Letterkenny Hospital	Donnegal		Ireland
3	St. Vincent's Hospital	Dublin		Ireland	4
4	Saint Luke's Hospital	Dublin		Ireland	6
5	Mater Misericordiae Hospital	Dublin		Ireland	7
6	Adelaide and Meath Hospital	Dublin		Ireland	8
7	Beaumont Hospital	Dublin		Ireland	9
8	Bon Secours Hospital	Galway		Ireland
9	Galway University Hospital	Galway		Ireland
10	Regional Hospital - Limerick	Limerick		Ireland
11	Sligo General	Sligo		Ireland
12	Belfast City Hospital Trust Incorporating Belvoir Park Hospital	Belfast	Northern Ireland	United Kingdom	BT8 8JR