|
Combination Hormone Therapy Followed by Radiation Therapy in Treating Patients With Prostate Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Combination Hormone Therapy Followed by Radiation Therapy in Treating Patients With Prostate Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Combination Hormone Therapy Followed by Radiation Therapy in Treating Patients With Prostate Cancer Clinical research trials and Combination Hormone Therapy Followed by Radiation Therapy in Treating Patients With Prostate Cancer health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Combination Hormone Therapy Followed by Radiation Therapy in Treating Patients With Prostate Cancer. Combination Hormone Therapy Followed by Radiation Therapy in Treating Patients With Prostate Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Combination Hormone Therapy Followed by Radiation Therapy in Treating Patients With Prostate Cancer clinical trial. Subjects frequently get the best healthcare possible for their Combination Hormone Therapy Followed by Radiation Therapy in Treating Patients With Prostate Cancer condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Combination Hormone Therapy Followed by Radiation Therapy in Treating Patients With Prostate Cancer Combination Hormone Therapy Followed by Radiation Therapy in Treating Patients With Prostate Cancer
Combination Hormone Therapy Followed by Radiation Therapy in Treating Patients With Prostate Cancer
For Condition: stage 3 prostate cancer,adenocarcinoma of the prostate,stage 4 prostate cancer,stage 1 prostate cancer,stage 2 prostate cancer
Status: No longer recruiting
Sponsor(s): St. Luke's Hospital ,
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnArmstrong, Study Chair, St. Luke's Hospital
Cork University Hospital
Cork, ,
Ireland
Beaumont Hospital
Dublin, , 9
Ireland
St. Vincent's Hospital
Dublin, , 4
Ireland
Mater Misericordiae Hospital
Dublin, , 7
Ireland
Sligo General
Sligo, ,
Ireland
Galway University Hospital
Galway, ,
Ireland
Regional Hospital - Limerick
Limerick, ,
Ireland
Letterkenny Hospital
Donnegal, ,
Ireland
Belfast City Hospital Trust Incorporating Belvoir Park Hospital
Belfast, Northern Ireland, BT8 8JR
United Kingdom
Adelaide and Meath Hospital
Dublin, , 8
Ireland
Bon Secours Hospital
Galway, ,
Ireland
Saint Luke's Hospital
Dublin, , 6
Ireland
Additional Information:
Study ID Numbers: CDR0000066849; ICORG-97-01,EU-98060
Study Start Date: December 1998
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003734
Other Stage 4 Prostate Cancer Studies:
1. Calcitriol and Zoledronate in Treating Patients With Progressive Prostate Cancer
2. Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer
3. MLN2704 in Treating Patients With Progressive Metastatic Prostate Cancer
4. Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer
5. Combination Chemotherapy Plus Filgrastim in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy
Related Studies:
Other stage 4 prostate cancer Clinical Trials
Other Clinical Trials
Other Galway Clinical Trials
Combination Hormone Therapy Followed by Radiation Therapy in Treating Patients With Prostate Cancer
|
|
|
|
|
|
|
|