Clinical trial NCT00003734: Combination Hormone Therapy Followed by Radiation Therapy in Treating Patients With Prostate Cancer
Official title: A Randomised Comparison of Short and Protracted Neoadjuvant Hormonal Therapy Prior to Radiation Therapy of High Risk Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-12-09
Enrollment: 276
Sex: MALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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.

Eligibility 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

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Cork University Hospital
city: Donnegal
country: Ireland
facility: Letterkenny Hospital
city: Dublin
country: Ireland
facility: St. Vincent's Hospital
city: Dublin
country: Ireland
facility: Saint Luke's Hospital
city: Dublin
country: Ireland
facility: Mater Misericordiae Hospital
city: Dublin
country: Ireland
facility: Adelaide and Meath Hospital
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Galway
country: Ireland
facility: Bon Secours Hospital
city: Galway
country: Ireland
facility: Galway University Hospital
city: Limerick
country: Ireland
facility: Regional Hospital - Limerick
city: Sligo
country: Ireland
facility: Sligo General
city: Belfast
country: United Kingdom
facility: Belfast City Hospital Trust Incorporating Belvoir Park Hospital
state: Northern Ireland
Study officials:
affiliation: Saint Luke's Hospital
name: John Gerard Armstrong, MD, MB, MRCPI
role: STUDY_CHAIR
References:
citation: Armstrong JG, Gillham CM, Dunne MT, Fitzpatrick DA, Finn MA, Cannon ME, Taylor JC, O'Shea CM, Buckney SJ, Thirion PG. A randomized trial (Irish clinical oncology research group 97-01) comparing short versus protracted neoadjuvant hormonal therapy before radiotherapy for localized prostate cancer. Int J Radiat Oncol Biol Phys. 2011 Sep 1;81(1):35-45. doi: 10.1016/j.ijrobp.2010.04.065. Epub 2010 Aug 25.