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Intermittent Androgen Deprivation in Patients With Stage D2 Prostate Cancer, Phase III

Phase 3
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

Intermittent Androgen Deprivation in Patients With Stage D2 Prostate Cancer, Phase III



- Compare the survival of patients with metastatic stage IV prostate cancer responsive to
combined androgen-deprivation therapy (CAD) treated with intermittent vs continuous

- Compare the effects of these treatment regimens on impotence, libido, and
vitality/fatigue as well as the physical and emotional well-being of these patients.


- Compare general symptoms, role functioning, global perception of quality of life, and
social functioning of patients treated with these regimens.

- Assess prostate-specific antigen (PSA) levels after continuous CAD administered before
randomization and evaluate PSA changes throughout randomized treatment of these

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to SWOG
performance status (0-1 vs 2), severity of disease (minimal vs extensive), and prior
hormonal therapy (neoadjuvant hormonal therapy vs finasteride vs neither).

- Induction therapy: Patients receive combined androgen-deprivation (CAD) therapy
comprising goserelin subcutaneously once a month and oral bicalutamide once daily for 8
courses (7 months).

- Consolidation therapy: Patients are randomized to 1 of 2 consolidation regimens.

- Arm I (continuous CAD therapy): Patients continue CAD therapy as in induction
therapy. Treatment continues in the absence of disease progression.

- Arm II (intermittent CAD therapy): Patients undergo observation in the absence of
rising prostate-specific antigen (PSA) or clinical symptoms of progressive
disease. Patients with rising PSA or progressive disease begin CAD therapy as in
induction therapy. Patients whose PSA normalizes after 8 courses return to
observation. Patients whose PSA does not normalize after 8 courses continue CAD

Quality of life is assessed before induction therapy, at 3 months (before consolidation
therapy), and then at 9 and 15 months.

Patients are followed every 6-12 months for at least 10 years.

PROJECTED ACCRUAL: Approximately 1,500 patients will be accrued for this study.

Inclusion Criteria


- Histologically or cytologically confirmed adenocarcinoma of the prostate

- Metastatic stage IV (stage D2)

- Any number of bone metastases by bone scan allowed

- Unequivocal visceral organ metastases (liver, brain, or lung) allowed

- No suspected second primary tumors unless metastases are histologically
confirmed, including special stains (e.g., prostate specific antigen [PSA] and
prostatic alkaline phosphatase [PAP])

- For entry into late induction therapy:

- No more than 1 month from the beginning of antiandrogen therapy to the beginning
of luteinizing hormone-releasing hormone (LHRH) agonist therapy

- No more than 6 months since initiation of current combined androgen-deprivation
therapy (LHRH agonist and antiandrogen)

- The effectiveness of the current depot LHRH agonist would not extend beyond 8
months after initiation of combined androgen therapy

- PSA at least 5 ng/mL

- No acute spinal cord compression



- Adult

Performance status:

- SWOG 0-2


- Not specified


- Not specified


- Not specified


- Recovered from any major infection

- No active medical illness that would preclude study or limit survival

- No other malignancy within the past 5 years except:

- Adequately treated basal cell or squamous cell skin cancer

- Adequately treated carcinoma in situ of the bladder

- Adequately treated other superficial cancer


Biologic therapy:

- No concurrent biological response modifier therapy


- No concurrent chemotherapy

Endocrine therapy:

- See Disease Characteristics

- More than 1 year since any prior neoadjuvant or adjuvant hormonal therapy for a
duration of no more than 4 months

- Single or combination therapy allowed

- More than 1 year since prior finasteride for prostate cancer for a duration of no
more than 9 months (less than 6 months for benign prostatic hypertrophy)

- Prior or concurrent megestrol for hot flashes allowed

- No other concurrent hormonal therapy


- No concurrent radiotherapy other than palliation of painful bone metastases


- No prior bilateral orchiectomy

- Recovered from any prior major surgery

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Treatment-specific symptoms as measured on the four-item Medical Outcomes Study Short Form-36 (SF-36) and Vitality scale

Safety Issue:


Principal Investigator

Maha Hadi A. Hussain, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Michigan Cancer Center



Study ID:




Start Date:

May 1995

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms