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Phase III Study of Chemo-Hormonal Therapy Versus Hormonal Therapy Alone in Advanced Hormone-Naives Prostate Cancer Patients.

Phase 3
18 Years
Open (Enrolling)
Pain, Prostate Cancer

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Trial Information

Phase III Study of Chemo-Hormonal Therapy Versus Hormonal Therapy Alone in Advanced Hormone-Naives Prostate Cancer Patients.



- Compare the 2-year progression-free survival rate (biological progression and/or
clinical progression) in patients with advanced prostate cancer treated with androgen
ablation with vs without docetaxel.


- Compare the overall survival of patients treated with these regimens.

- Compare the time to treatment failure in patients treated with these regimens.

- Compare the toxicity profiles of these regimens in these patients.

- Compare the PSA response rate in patients treated with these regimens.

- Compare the response rate in patients with measurable disease treated with these

- Compare the percentage of patients who undergo PSA normalization.

- Compare the quality of life of patients treated with these regimens.

- Compare the efficacy of these regimens in controlling bone pain in these patients.

- Compare the changes in chromogranin A levels in patients treated with these regimens.

- Compare the total cost of care of patients treated with these regimens.

OUTLINE: This is a multicenter study.

Patients receive luteinizing hormone-releasing hormone analogue (LHRH-A) therapy for 6
months. Patients also receive antiandrogen therapy during the first 5 weeks of LHRH-A
therapy. After 6 months of LHRH-A therapy, patients with PSA response are randomized to 1 of
2 treatment arms.

- Arm I: Patients continue to receive LHRH-A therapy until disease progression.

- Arm II:Patients receive LHRH-A therapy as in arm I. Patients also receive docetaxel IV
on day 1. Treatment with docetaxel repeats every 21 days for up to 4 courses in the
absence of disease progression or unacceptable toxicity.

Patients complete questionnaires during treatment to assess bone pain. Quality of life is
also assessed.

After completion to study therapy, patients are followed for ≥ 2 years.

Inclusion Criteria


- Histologically confirmed adenocarcinoma of the prostate

- Meets one of the following criteria

- Metastatic disease

- Systemic progressive disease after locoregional therapy (surgery or

- No metastatic disease AND meets one of the following criteria:

- Circulating PSA levels ≥ 50 ng/mL (confirmed by ≥ 2 subsequent evaluations)

- Biochemical progression with a PSA doubling time < 6 months (with ≥ 3
measurements taken 1 month apart) after primary locoregional treatment
(radical prostatectomy or radiotherapy) with curative intent

- Prostate-confined tumor with high-risk features whose therapy of choice is
androgen deprivation

- No symptomatic brain metastases or leptomeningeal disease


- ECOG or Zubrod performance status 0-2

- Life expectancy ≥ 6 months

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 10 g/dL

- Bilirubin ≤ 2.0 mg/dL

- AST/ALT ≤ 1.5 times upper limit of normal

- Creatinine ≤ 1.5 mg/dL

- No active infection requiring IV antibiotics

- No active ulcer, unstable diabetes mellitus, or other contraindication to

- None of the following cardiovascular conditions:

- Uncompensated heart failure (ejection fraction < 40%)

- Myocardial infarction or revascularization procedure within the past 6 months

- Unstable angina pectoris

- Uncontrolled cardiac arrhythmia

- No other severe clinical condition that, in the judgment of the local investigator,
would place the patient at undue risk or interfere with the study

- Not a prisoner

- No prior malignancy, except for non-melanoma skin cancer, in situ cervical carcinoma,
or other cancer that was curatively treated with no evidence of disease for ≥ 5 years

- No familial, social, or geographical condition or significant neurologic or
psychiatric disorder that would preclude understanding or rendering informed consent
or fully complying with study treatment and follow-up


- At least 5 years since prior radiotherapy outside the prostate

- Prior hormonal therapy allowed provided it was administered for ≤ 6 months

- At least 12 months since prior hormonal therapy

- More than 30 days since prior participation in another clinical trial involving
investigational agents

- No prior surgical castration

- Concurrent androgen deprivation for prostate cancer allowed provided it was started ≤
3 months prior to initiation of study treatment

- Concurrent anticoagulant treatment allowed

- No other concurrent investigational drugs

Type of Study:


Study Design:

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

Outcome Measure:

2-year progression-free survival rate

Safety Issue:


Principal Investigator

Oscar Bertetto, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino



Study ID:




Start Date:

April 2005

Completion Date:

Related Keywords:

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