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| Sponsored by: |
Saint Luke's Hospital |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003734 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: flutamide Drug: triptorelin Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| Official Title: | A Randomised Comparison of Short and Protracted Neoadjuvant Hormonal Therapy Prior to Radiation Therapy of High Risk Localized Prostate Cancer |
| Estimated Enrollment: | 276 |
| Study Start Date: | December 1998 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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| Ireland | |
| Adelaide and Meath Hospital | |
| Dublin, Ireland, 8 | |
| Beaumont Hospital | |
| Dublin, Ireland, 9 | |
| Bon Secours Hospital | |
| Galway, Ireland | |
| Letterkenny Hospital | |
| Donnegal, Ireland | |
| Galway University Hospital | |
| Galway, Ireland | |
| Cork University Hospital | |
| Cork, Ireland | |
| Mater Misericordiae Hospital | |
| Dublin, Ireland, 7 | |
| Regional Hospital - Limerick | |
| Limerick, Ireland | |
| Saint Luke's Hospital | |
| Dublin, Ireland, 6 | |
| Sligo General | |
| Sligo, Ireland | |
| St. Vincent's Hospital | |
| Dublin, Ireland, 4 | |
| United Kingdom, Northern Ireland | |
| Belfast City Hospital Trust Incorporating Belvoir Park Hospital | |
| Belfast, Northern Ireland, United Kingdom, BT8 8JR | |
| Study Chair: | John Gerard Armstrong, MD, MB, MRCPI | Saint Luke's Hospital |
More Information
| Study ID Numbers: | CDR0000066849, ICORG-97-01, EU-98060 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003734 History of Changes |
| Health Authority: | United States: Federal Government |
|
adenocarcinoma of the prostate stage I prostate cancer stage II prostate cancer stage III prostate cancer stage IV prostate cancer |
|
Antineoplastic Agents, Hormonal Prostatic Diseases Genital Neoplasms, Male Contraceptive Agents Triptorelin Contraceptive Agents, Female |
Urogenital Neoplasms Flutamide Genital Diseases, Male Adenocarcinoma Hormones Prostatic Neoplasms |
|
Antineoplastic Agents, Hormonal Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Contraceptive Agents Physiological Effects of Drugs Contraceptive Agents, Female Urogenital Neoplasms Reproductive Control Agents |
Genital Diseases, Male Luteolytic Agents Pharmacologic Actions Neoplasms Neoplasms by Site Triptorelin Therapeutic Uses Prostatic Neoplasms |
