Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer
Recruitment status was Active, not recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
RATIONALE: Hormones can stimulate the production of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy plus radiation therapy is more effective with or without combination chemotherapy for prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy plus radiation therapy with or without combination chemotherapy in treating patients who have prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: bicalutamide Drug: estramustine phosphate sodium Drug: etoposide Drug: flutamide Drug: paclitaxel Drug: releasing hormone agonist therapy Radiation: radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A Phase III Protocol of Androgen Suppression (AS) and Radiation Therapy (RT) vs AS and RT Followed by Chemotherapy With Paclitaxel, Estramustine, and Etoposide (TEE) for Localized, High-Risk, Prostate Cancer |
| Estimated Enrollment: | 1440 |
| Study Start Date: | January 2000 |
OBJECTIVES:
- Compare the efficacy of androgen suppression and radiotherapy with or without subsequent paclitaxel, estramustine, and etoposide, in terms of overall and disease-free survival, biochemical and local control, and freedom from distant metastasis, in patients with localized high-risk prostate cancer.
- Compare the toxic effects of these regimens in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to prostate-specific antigen level (≤ 10 ng/mL vs 11-100 ng/mL), tumor stage (T1-2 vs T3-4), Gleason score (7 vs 8-10), and prior hormone use (yes vs no). Patients are randomized to one of two treatment arms.
All patients receive androgen suppression comprising a luteinizing hormone-releasing hormone (LHRH) agonist AND bicalutamide OR flutamide for 4 months. Beginning 8 weeks after the initiation of androgen suppression, all patients undergo radiotherapy once daily, 5 days a week, for 7-8 weeks. Patients who received prior androgen suppression therapy count time to radiotherapy from start date of prior hormonal therapy.
- Arm I: Patients continue androgen suppression therapy (LHRH agonist only) for approximately 20 more months after radiotherapy is completed.
- Arm II: Patients continue therapy as in arm I and receive chemotherapy beginning 28 days after completing radiotherapy. Chemotherapy comprises oral estramustine 3 times daily and oral etoposide twice daily on days 1-14 and paclitaxel IV over 1 hour on day 2. Chemotherapy repeats every 21 days for 4 courses.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,440 patients will be accrued for this study within 6 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven prostate cancer at high risk for relapse as determined by either of the following:
- Prostate-specific antigen (PSA) 20-100 ng/mL and Gleason score at least 7 (any T stage)
- Clinical stage at least T2, Gleason score at least 8, and PSA no greater than 100 ng/mL
- Negative lymph nodes
- No metastatic disease
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- Zubrod 0 or 1
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm^3
- Platelet count at least 130,000/mm^3
- Hemoglobin at least 11.4 g/dL
Hepatic:
- AST no greater than 2 times upper limit of normal
Renal:
- Creatinine no greater than 2.5 mg/dL
Other:
- No other invasive cancer within the past 5 years except superficial nonmelanomatous skin cancer
- No major medical or psychiatric illness that would preclude study participation
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 5 years since prior chemotherapy
Endocrine therapy:
- At least 60 days since prior finasteride for prostatic hypertrophy
- At least 90 days since prior testosterone
- No more than 30 days since initiation of prior pharmacologic androgen ablation for prostate cancer
Radiotherapy:
- No prior pelvic radiotherapy
- No concurrent intensity-modulated radiotherapy
Surgery:
- No prior radical prostatectomy
- No prior cryosurgery for prostate cancer
- No prior orchiectomy
Contacts and Locations
Show 54 Study Locations| Study Chair: | Howard M. Sandler, MD | University of Michigan Cancer Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00004054 History of Changes |
| Other Study ID Numbers: | CDR0000067250, RTOG-9902, RTOG-DEV-1020 |
| Study First Received: | December 10, 1999 |
| Last Updated: | February 18, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage IIB prostate cancer stage IIA prostate cancer stage III prostate cancer stage IV prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Estramustine Flutamide Etoposide phosphate Bicalutamide Etoposide Paclitaxel Hormones Sodium phosphate |
Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Androgen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Cathartics Gastrointestinal Agents Tubulin Modulators |
ClinicalTrials.gov processed this record on May 16, 2013