Hormone Therapy and Docetaxel or Hormone Therapy Alone in Treating Patients With Metastatic Prostate Cancer
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| ClinicalTrials.gov Identifier: NCT00104715 |
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Recruitment Status :
Completed
First Posted : March 4, 2005
Last Update Posted : February 21, 2021
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RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as goserelin, may stop the adrenal glands from making androgens. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving hormone therapy together with docetaxel may be an effective treatment for prostate cancer. It is not yet known whether giving hormone therapy together with docetaxel is more effective than hormone therapy alone in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying hormone therapy and docetaxel to see how well they work compared to hormone therapy alone in treating patients with metastatic prostate cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prostate Cancer | Drug: antiandrogen therapy Drug: docetaxel Drug: goserelin acetate Procedure: orchiectomy | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 385 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Randomized Phase III Trial Comparing an Association of Hormonal Treatment and Docetaxel Versus the Hormonal Treatment Alone in Metastatic Prostate Cancers |
| Actual Study Start Date : | October 18, 2004 |
| Actual Primary Completion Date : | December 4, 2011 |
| Actual Study Completion Date : | December 15, 2015 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Hormonotherapy + chemotherapy |
Drug: antiandrogen therapy Drug: docetaxel Drug: goserelin acetate Procedure: orchiectomy |
| Active Comparator: Hormonotherapy alone |
Drug: antiandrogen therapy Drug: goserelin acetate Procedure: orchiectomy |
- Overall survival at 36 months
- Progression-free survival (biological progression and/or clinical progression) at 24 months
- Quality of life
- Treatment costs
- Toxicity and tolerance
- Tumor profiles of gene expression as measured by biochips with DNA and tissue microarrays
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| Ages Eligible for Study: | 18 Years to 120 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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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
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00104715
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| Study Chair: | Gwenaelle Gravis, MD | Institut Paoli-Calmettes |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | UNICANCER |
| ClinicalTrials.gov Identifier: | NCT00104715 |
| Other Study ID Numbers: |
UC-0160/0403 FRE-FNCLCC-GETUG-15/0403 EU-20505 |
| First Posted: | March 4, 2005 Key Record Dates |
| Last Update Posted: | February 21, 2021 |
| Last Verified: | February 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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adenocarcinoma of the prostate recurrent prostate cancer stage IV prostate cancer |
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Genital Diseases Urogenital Diseases Prostatic Diseases Male Urogenital Diseases Docetaxel |
Goserelin Androgen Antagonists Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |