Hormone Therapy in Treating Patients With Advanced Prostate Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer
Intervention: bicalutamide (Drug); flutamide (Drug); triptorelin (Drug); radiation therapy (Procedure)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: European Organization for Research and Treatment of Cancer Official(s) and/or principal investigator(s):
Michel Bolla, MD, Study Chair, Affiliation: CHU de Grenoble - Hopital de la Tronche
T. M. de Reijke, MD, PhD, Study Chair, Affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Summary
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using
triptorelin may fight prostate cancer by reducing the production of androgens.
PURPOSE: Randomized phase III trial to compare the effectiveness of long-term hormone therapy
and triptorelin with no further treatment in treating patients who have advanced prostate
cancer previously treated with radiation therapy and 6 months of androgen suppression.
Clinical Details
Official title: Long Term Adjuvant Hormonal Treatment With LHRH Analogue Versus No Further Treatment in Locally Advanced Prostatic Carcinoma Treated by External Irradiation and a Six Months Combined Androgen Blockade - A Phase III Study
Study design: Treatment, Randomized, Active Control
Detailed description:
OBJECTIVES:
- Determine the best hormonal scheme to be associated with pelvic radiotherapy in the
curative management of prostatic carcinoma for hormonal treatment with regards to
treatment outcome (overall survival, clinical disease free survival, local regional
control), quality of life (treatment side effects, sexual function), and health economy
(cost effectiveness ratio).
OUTLINE: This is a randomized, multicenter study.
Patients receive external radiation for 5 weeks, followed by a pelvic boost given for 2 weeks
and a 6 month combined androgen blockage initiated at the onset of external irradiation.
Flutamide (Eulexin) or bicalutamide (Casodex) may be used as the antiandrogens. Antiandrogen
treatment starts 1 week before the first injection of triptorelin.
Patients are then randomized to one of two treatment arms.
- Arm I: Patients receive no further treatment.
- Arm II: Patients receive antiandrogen for 2. 5 years plus and LHRH analogue (triptorelin)
administered every 3 months. Patients then continue the LHRH analogue alone for an
additional 2. 5 years in the absence of disease progression.
Patients are followed every 6 months for 5 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 966 patients will be accrued over 5 years.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- T1c-T2a-b, N1-2 or pN1-2 (after pelvic lymphadenectomy)
- T2c-T4, N0-2
- Prior external radiotherapy for locally advanced prostatic carcinoma required
- Prior hormone therapy (6 months of combined androgen blockade) for locally advanced
prostatic carcinoma required with PSA no greater than 150 ng/mL before administration
- No progressive disease after the 6 months of combined androgen blockage
- No stages T1c/T2a-b with a negative pelvic lymph nodes status that is assessed
clinically or surgically
- No lymph node involvement to common iliac and/or periaortic lymph nodes (M1a)
- No external iliac lymph node metastasis more than 5 cm in greatest dimension (N3)
- No distant metastases
PATIENT CHARACTERISTICS:
Age:
- Any age
Performance status:
- WHO 0-2
Life expectancy:
- At least 5 years
Hematopoietic:
- Hemoglobin at least 10 g/dL
- WBC at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No prior or concurrent cancers other than basal cell skin cancer
- No serious nonmalignant disease resulting in a life expectancy of less than 5 years
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior biologic therapy for prostate cancer
Chemotherapy
- No prior chemotherapy for prostate cancer
Endocrine therapy
- See Disease Characteristics
Radiotherapy
- See Disease Characteristics
Surgery
- See Disease Characteristics
Locations and Contacts
Academisch Ziekenhuis der Vrije Universiteit Brussel, Brussels 1090, Belgium
Institut Jules Bordet, Brussels (Bruxelles) 1000, Belgium
U.Z. Gasthuisberg, Leuven B-3000, Belgium
Universitair Ziekenhuis Antwerpen, Edegem B-2650, Belgium
Universitair Ziekenhuis Gent, Ghent B-9000, Belgium
Virga Jesse Hospital, Hasselt 3500, Belgium
Rambam Medical Center, Haifa 31096, Israel
St. Luke's Hospital and Medical School, Guardamangia MSD 07, Malta
Academisch Medisch Centrum, Amsterdam 1105 AZ, Netherlands
Academisch Ziekenhuis Groningen, Groningen 9700 RB, Netherlands
Academisch Ziekenhuis Maastricht, Maastricht 6202 AZ, Netherlands
Groot Ziekengasthuis 's-Hertogenbosch, 's-Hertogenbosch 5200 ME, Netherlands
Onze Lieve Vrouwe Gasthuis, Amsterdam 1091 HA, Netherlands
St. Elisabeth Ziekenhuis, Tilburg 5022 GC, Netherlands
Medical Radiological Research Center, Obninsk, Russian Federation
Marmara University Hospital, Istanbul 81190, Turkey
City General Hospital, Stoke-On-Trent, England ST4 6QG, United Kingdom
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: April 1997
Last updated: May 23, 2008
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