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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

Phase 3
18 Years
Open (Enrolling)
Prostate Cancer

Thank you

Trial Information

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


- 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

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.

Inclusion Criteria


- 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

- Clinical stage at least T2, Gleason score at least 8, and PSA no greater than
100 ng/mL

- Negative lymph nodes

- No metastatic disease



- Over 18

Performance status:

- Zubrod 0 or 1

Life expectancy:

- Not specified


- WBC at least 3,000/mm^3

- Platelet count at least 130,000/mm^3

- Hemoglobin at least 11.4 g/dL


- AST no greater than 2 times upper limit of normal


- Creatinine no greater than 2.5 mg/dL


- 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


Biologic therapy:

- Not specified


- 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


- No prior pelvic radiotherapy

- No concurrent intensity-modulated radiotherapy


- No prior radical prostatectomy

- No prior cryosurgery for prostate cancer

- No prior orchiectomy

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Howard M. Sandler, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Michigan Cancer Center


United States: Federal Government

Study ID:




Start Date:

January 2000

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms



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