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A Phase III Trial to Evaluate the Duration of Neoadjuvant Total Androgen Suppression (TAS) and Radiation Therapy (RT) in Intermediate-Risk Prostate Cancer

Phase 3
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

A Phase III Trial to Evaluate the Duration of Neoadjuvant Total Androgen Suppression (TAS) and Radiation Therapy (RT) in Intermediate-Risk Prostate Cancer


- Compare the efficacy of moderate-duration (28 weeks) neoadjuvant total androgen
suppression (TAS) and radiotherapy (RT) with short-duration (8 weeks) neoadjuvant TAS
and RT, as related to disease-specific survival, in patients with intermediate-risk
adenocarcinoma of the prostate.

- Compare these regimens, in terms of overall survival, disease-free survival, time to
local tumor progression or distant failure, time to first biochemical failure,
hormone-refractory state, and treatment-induced morbidity, in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
prostate-specific antigen level (no greater than 10 ng/mL vs greater than 10 but no greater
than 20 ng/mL vs greater than 20 ng/mL), tumor stage (T1b-2 vs T3-4), Gleason score (2-4 vs
5-6 vs 7-10), and prior hormonal therapy (yes vs no). Patients are randomized to one of two
treatment arms.

- Arm I: Patients receive total androgen suppression for 8 weeks prior to the initiation
of radiotherapy and throughout radiotherapy. A luteinizing hormone-releasing hormone
(LHRH) agonist is administered every 1-3 months AND bicalutamide OR flutamide is given
orally daily for a total duration of 16 weeks. Beginning with week 9, patients undergo
radiotherapy 5 days a week for 8 weeks.

- Arm II: Patients receive total androgen suppression for 28 weeks prior to the
initiation of radiotherapy and throughout radiotherapy. An LHRH agonist AND
bicalutamide OR flutamide are administered as in arm I for a total duration of 36
weeks. Beginning with week 29, patients undergo radiotherapy as in arm I.

Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 1,540 patients (770 per treatment arm) will be accrued for
this study within 4 years.

Inclusion Criteria


- Histologically confirmed adenocarcinoma of the prostate

- Intermediate risk for disease relapse as determined by any of the following
combination of factors:

- T1b-4, Gleason score 2-6, and prostate-specific antigen (PSA) greater than 10
but no greater than 100 ng/mL

- T1b-4, Gleason score 7, and PSA less than 20 ng/mL

- T1b-1c, Gleason score 8-10, and PSA less than 20 ng/mL

- Must have disease confirmation within 180 days of study randomization

- Clinically negative lymph nodes (N0) as established by imaging or negative lymph
nodes by nodal sampling or dissection

- Radiologic or radioimmunoscintigraphy findings suggestive of regional nodal
involvement allowed provided cytologic or histologic evaluation shows no
evidence of a neoplastic process

- Equivocal radiologic findings (i.e., maximum nodal size no greater than 1.5 cm)

- No distant metastases (M0)

- Radionuclide imaging findings suggestive but not diagnostic of metastatic
disease allowed provided radiologic imaging does not confirm metastatic disease



- 18 and over

Performance status:

- Zubrod 0 or 1

Life expectancy:

- At least 10 years


- Not specified


- ALT no greater than 2 times upper limit of normal


- Not specified


- Fertile patients must use effective contraception

- No other concurrent medical illness that would result in a life expectancy of less
than 10 years

- No other invasive malignancy within the past 5 years except localized basal cell or
squamous cell skin cancer

- No other concurrent major medical or psychiatric illness that would preclude study
treatment or follow-up


Biologic therapy:

- Not specified


- No prior chemotherapy for prostate cancer

Endocrine therapy:

- No prior androgen-deprivation therapy except luteinizing hormone-releasing hormone
(LHRH) agonist AND bicalutamide OR flutamide provided:

- LHRH agonist was initiated no more than 30 days before study randomization and
bicalutamide OR flutamide was initiated no more than 14 days before or after
LHRH agonist administration

- No concurrent finasteride for prostatic hypertrophy


- No prior pelvic external beam radiotherapy

- No prior radionuclide prostate brachytherapy

- No concurrent intensity-modulated radiotherapy


- No prior prostatectomy

- No prior prostatic cryosurgery

- No prior bilateral orchiectomy


- No other concurrent medical research study involving prostate cancer treatment

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Michael G. Haddock, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

February 2000

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • Prostatic Neoplasms



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