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Randomized Phase III Trial Comparing an Association of Hormonal Treatment and Docetaxel Versus the Hormonal Treatment Alone in Metastatic Prostate Cancers


Phase 3
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Randomized Phase III Trial Comparing an Association of Hormonal Treatment and Docetaxel Versus the Hormonal Treatment Alone in Metastatic Prostate Cancers


OBJECTIVES:

- Compare 36-month overall survival of patients with metastatic prostate adenocarcinoma
treated with hormonal therapy and docetaxel vs hormonal therapy alone.

- Compare 24-month progression-free survival (biological progression and/or clinical
progression) in patients treated with these regimens.

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

- Compare costs of these regimens for these patients.

- Compare the tolerability of these regimens in these patients.

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

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
treatment arms.

- Arm I: Patients receive hormonal therapy comprising 1 of the following: goserelin alone
OR goserelin and antiandrogen therapy OR surgical castration. Hormonal therapy
continues until the development of hormone resistance. Within 2 months after initiation
of hormonal therapy, patients receive docetaxel IV every 3 weeks for up to 9 courses in
the absence of disease progression or unacceptable toxicity.

- Arm II: Patients receive hormonal therapy as in arm I. Quality of life is assessed.

PROJECTED ACCRUAL: A total of 378 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed prostate adenocarcinoma

- Metastatic disease

- Measurable or evaluable disease

- No brain metastases

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 3 months

Hematopoietic

- WBC ≥ 2,000/mm^3

- Absolute neutrophil count ≥ 1,000/mm^3

- Platelet count ≥ 100,000/mm^3

Hepatic

- Bilirubin ≤ 1.5 times upper limit of normal (ULN) (2.5 times normal if hepatic
metastases are present)

- AST and ALT ≤ 1.5 times ULN (2.5 times normal if hepatic metastases are present)

Renal

- Creatinine ≤ 150 μmol/L

Cardiovascular

- No symptomatic coronary disease

- No congenital cardiac insufficiency

- No New York Heart Association class III or IV cardiovascular disease

- No other severe cardiovascular disease

Other

- No severe peripheral neuropathy

- No active infection

- No other malignancy within the past 5 years except basal cell skin cancer

- No familial, social, geographical, or psychological situation that would preclude
study compliance and follow-up

- No other serious disease that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior chemotherapy for metastatic prostate cancer

- Prior chemotherapy allowed provided all of the following are true:

- Chemotherapy was completed > 1 year ago

- Prostate-specific antigen level has remained stable

- No development of metastases within 1 year after completion of chemotherapy

Endocrine therapy

- Prior hormonal therapy within the past 2 months allowed for metastatic prostate
cancer

Radiotherapy

- More than 4 weeks since prior radiotherapy to metastatic sites

Surgery

- No prior surgical castration

Other

- No other concurrent investigational drugs

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Overall survival at 36 months

Safety Issue:

No

Principal Investigator

Gwenaelle Gravis, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Institut Paoli-Calmettes

Authority:

United States: Federal Government

Study ID:

CDR0000416096

NCT ID:

NCT00104715

Start Date:

October 2004

Completion Date:

Related Keywords:

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

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