Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer - Full Text View

Sponsors and Collaborators:	Radiation Therapy Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00004054

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 III

MedlinePlus related topics: Cancer Prostate Cancer Radiation Therapy

Drug Information available for: Flutamide Paclitaxel Etoposide Estramustine phosphate sodium Bicalutamide Etoposide phosphate Estramustine Estramustine phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
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

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	1440
Study Start Date:	January 2000

Detailed Description:

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004054

Show 54 Study Locations

Sponsors and Collaborators

Radiation Therapy Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Howard M. Sandler, MD

University of Michigan Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Rosenthal SA, Bae K, Pienta KJ, Sobczak ML, Asbell SO, Rajan R, Kerlin KJ, Michalski JM, Sandler HM. Phase III Multi-Institutional Trial of Adjuvant Chemotherapy with Paclitaxel, Estramustine, and Oral Etoposide Combined with Long-Term Androgen Suppression Therapy and Radiotherapy Versus Long-Term Androgen Suppression Plus Radiotherapy Alone For High-Risk Prostate Cancer: Preliminary Toxicity Analysis of RTOG 99-02. Int J Radiat Oncol Biol Phys. 2008 Nov 4; [Epub ahead of print]

Sandler HM, DeSilvio M, Pienta KJ, et al.: Preliminary analysis of RTOG 9902: increased toxicity observed with the use of adjuvant chemotherapy. [Abstract] 2006 Prostate Cancer Symposium, February 24-26, 2006, San Francisco, CA. A-190, 2006.

Study ID Numbers:	CDR0000067250, RTOG-9902, RTOG-DEV-1020
Study First Received:	December 10, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00004054 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer

Study placed in the following topic categories:

Antineoplastic Agents, Hormonal
Genital Neoplasms, Male
Prostatic Diseases
Hormone Antagonists
Estramustine
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Antimitotic Agents
Genital Diseases, Male
Flutamide
Etoposide phosphate

Hormones
Androgen Antagonists
Paclitaxel
Tubulin Modulators
Bicalutamide
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Alkylating Agents
Prostatic Neoplasms
Etoposide
Androgens

Additional relevant MeSH terms:

Prostatic Diseases
Genital Neoplasms, Male
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Hormone Antagonists
Estramustine
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Hormones
Neoplasms by Site
Therapeutic Uses
Etoposide
Alkylating Agents

Antineoplastic Agents, Hormonal
Mitosis Modulators
Antimitotic Agents
Genital Diseases, Male
Pharmacologic Actions
Androgen Antagonists
Neoplasms
Paclitaxel
Tubulin Modulators
Bicalutamide
Antineoplastic Agents, Alkylating
Prostatic Neoplasms
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 07, 2009