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Adjuvant Androgen Deprivation Versus Mitoxantrone Plus Prednisone Plus Androgen Deprivation in Selected High-Risk Prostate Cancer Patients Following Radical Prostatectomy

Phase 3
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

Adjuvant Androgen Deprivation Versus Mitoxantrone Plus Prednisone Plus Androgen Deprivation in Selected High-Risk Prostate Cancer Patients Following Radical Prostatectomy


- Compare the overall and disease-free survival of patients with high-risk adenocarcinoma
of the prostate treated with adjuvant androgen deprivation therapy with or without
mitoxantrone and prednisone after radical prostatectomy.

- Compare the qualitative and quantitative toxic effects of these regimens in this
patient population.

- Compare the prostate-specific antigen (PSA) progression-free survival rate in patient
treated with these regimens.

- Determine whether PSA progression is a surrogate endpoint for survival or disease-free
survival in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
surgical extent of disease (organ confined vs not organ confined, but N0 vs N1), Gleason's
sum (less than 7 vs 7 vs greater than 7), and planned radiotherapy (yes vs no). Patients are
randomized to one of two treatment arms.

- Arm I:Patients receive goserelin subcutaneously once every 13 weeks (8 injections
total) and oral bicalutamide once daily for 2 years in the absence of disease
progression or unacceptable toxicity.

- Arm II:Patients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone
twice daily on days 1-21. Treatment repeats every 3 weeks for 6 courses in the absence
of disease progression or unacceptable toxicity. Patients also receive hormonal therapy
as in arm I beginning concurrently with the initiation of mitoxantrone and prednisone.

Patients may undergo radiotherapy 5 days a week for 6.5-7.8 weeks beginning anytime (arm I)
or after completion of chemotherapy (arm II), at the discretion of the physician, in the
absence of disease progression or unacceptable toxicity.

Patients are offered the possibility to participate in biomarker research by allowing their
tissue/blood to be studied.

Patients are followed every 6 months for 2 years and then annually for up to 13 years.

PROJECTED ACCRUAL: A total of 1,360 patients (680 per treatment arm) will be accrued for
this study within 9.5 years.

Inclusion Criteria


- Histologically confirmed stage T1-T3 adenocarcinoma of the prostate before radical
prostatectomy and lymph node dissection

- Must have undergone prostatectomy within the past 120 days

- Must meet at least 1 of the following pathologic criteria:

- Gleason sum at least 8

- pT3b (seminal vesicle), pT4, or N1

- Gleason sum of 7 and positive margin

- Preoperative PSA greater than 15 ng/mL, Gleason score greater than 7, or PSA
level greater than 10 ng/mL and Gleason score greater than 6

- Must have an undetectable PSA (no greater than 0.2 ng/mL) documented after surgery or
prior to adjuvant hormonal therapy (for patients initiating adjuvant hormonal therapy
prior to study)

- No evidence of metastatic disease on bone scan if PSA is 20 ng/mL or greater at
clinical diagnosis

- No distant metastatic disease


Performance status:

- SWOG 0-1

Life expectancy:

- Not specified


- Not specified


- Not specified


- Not specified


- No uncontrolled congestive heart failure

- If history of cardiac disease, LVEF at least 50% by MUGA scan or 2-D echocardiogram


- No HIV positivity

- No other prior malignancy within the past 5 years except adequately treated basal
cell or squamous cell skin cancer or stage I or II cancer that is currently in
complete remission


Biologic therapy:

- Not specified


- Not specified

Endocrine therapy:

- Prior neoadjuvant hormonal therapy of no more than 4 months duration before radical
prostatectomy allowed

- Other concurrent adjuvant hormonal therapy allowed if initiated prior to study

- Concurrent low-dose megestrol (less than 40 mg/day) for hot flashes allowed


- No prior radiotherapy

- No concurrent whole pelvis irradiation

- Concurrent radiotherapy allowed at the discretion of the physician


- See Disease Characteristics

- See Endocrine therapy

- Recovered from prior surgery


- No other prior or concurrent therapy for adenocarcinoma of the prostate

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

at month 4 and every 3 months for 2 years

Safety Issue:


Principal Investigator

L. Michael Glode, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Colorado, Denver


United States: Federal Government

Study ID:




Start Date:

October 1999

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage I prostate cancer
  • stage II prostate cancer
  • stage III prostate cancer
  • Prostatic Neoplasms



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