Docetaxel and Prednisone in Treating Patients With Hormone-Refractory Metastatic Prostate Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00255606
First received: November 18, 2005
Last updated: June 25, 2013
Last verified: September 2010

November 18, 2005
June 25, 2013
August 2005
May 2009   (final data collection date for primary outcome measure)
Time to treatment failure (TTF) [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00255606 on ClinicalTrials.gov Archive Site
  • Quality of life every 6 weeks until TTF [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]
  • Overall survival [ Designated as safety issue: No ]
  • Response rate [ Designated as safety issue: No ]
  • Use of epoetin beta [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Docetaxel and Prednisone in Treating Patients With Hormone-Refractory Metastatic Prostate Cancer
A Phase III Trial Comparing Docetaxel Every Third Week to Biweekly Docetaxel Monotherapy in Metastatic Hormone Refractory Prostate Cancer Patients - PROSTY Trial

RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which schedule of docetaxel and prednisone is more effective in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying two different schedules of docetaxel and prednisone to compare how well they work in treating patients with metastatic prostate cancer.

OBJECTIVES:

Primary

  • Compare the time to treatment failure in patients with hormone-refractory metastatic prostate cancer treated with two different schedules of docetaxel in combination with prednisone.

Secondary

  • Compare overall survival of patients treated with these regimens.
  • Compare the response rate in patients treated with these regimens.
  • Compare the safety of these regimens in these patients.
  • Compare the quality of life of patients treated with these regimens.
  • Compare the need for epoetin beta in patients treated with these regimens.
  • Determine the effect of epoetin beta on hemoglobin response rate, transfusion rate, and quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to participating center and WHO performance status (0-1 vs 2). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive docetaxel IV over 1 hour on days 1 and 15 and oral prednisone once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive docetaxel IV over 1 hour on day 1 and prednisone once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients who experience anemia (hemoglobin < 11 g/dL) receive epoetin beta subcutaneously once weekly during chemotherapy.

Quality of life is assessed at baseline, every 6 weeks during study treatment, at completion of study treatment, and then every 2 months thereafter.

After completion of study treatment, patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 360 patients (180 per treatment arm) will be accrued for this study within 4 years.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Prostate Cancer
  • Drug: docetaxel
    Given in 3- or 4- week courses
  • Drug: prednisone
    Given in 3- or 4- week courses
  • Experimental: Arm I
    Patients receive docetaxel IV over 1 hour on days 1 and 15 and oral prednisone once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    Interventions:
    • Drug: docetaxel
    • Drug: prednisone
  • Experimental: Arm II
    Patients receive docetaxel IV over 1 hour on day 1 and prednisone once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    Interventions:
    • Drug: docetaxel
    • Drug: prednisone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
360
August 2010
May 2009   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate

    • Metastatic disease by imaging or clinical examination
  • Hormone-refractory disease, defined as prostate-specific antigen (PSA) level > 10 µg/L AND rising between 2 sequential measurements
  • Testosterone within castration levels by orchiectomy or medical castration comprising luteinizing hormone-releasing hormone (LHRH) analogues

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • WHO 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Neutrophil count ≥ 1,500/mm^3
  • Hemoglobin ≥ 11.0 g/dL
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • ALT and AST ≤ 2.5 times upper limit of normal (ULN)
  • Bilirubin normal
  • Alkaline phosphatase ≤ 6 times ULN (unless due to the presence of extensive bone disease)
  • No serious liver disease

Renal

  • Creatinine ≤ 1.5 times ULN

Cardiovascular

  • No ischemic or thromboembolic cardiac disease
  • No myocardial infarction within the past 12 months
  • No other serious cardiac disease

Pulmonary

  • No pulmonary emboli

Immunologic

  • No active infection
  • No autoimmune disease, including any of the following:

    • Lupus
    • Scleroderma
    • Rheumatoid polyarthritis

Other

  • No active peptic ulcer
  • No unstable diabetes mellitus
  • No contraindication to corticosteroids
  • No other malignant disease within the past 5 years except basalioma
  • No functional iron deficiency (i.e., transferrin saturation < 20%) that cannot be treated with iron supplementation
  • No other serious illness or medical condition

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 2 months since prior recombinant human epoetin alfa or any other erythropoiesis-stimulating drug

Chemotherapy

  • At least 3 weeks since prior estramustine

Endocrine therapy

  • See Disease Characteristics
  • At least 3 weeks since prior antiandrogen treatment
  • Concurrent chemical castration with LHRH allowed provided patient has begun treatment prior to study entry

    • No initiation of chemical castration therapy during study treatment

Radiotherapy

  • No prior radiotherapy to > 25% of bone marrow
  • No prior radioisotope therapy
  • Concurrent local palliative radiotherapy for pain allowed

Surgery

  • See Disease Characteristics
  • At least 4 weeks since prior surgery

Other

  • No other prior cytostatic treatment
  • Concurrent bisphosphonates allowed provided patient has begun treatment prior to study entry

    • No initiation of bisphosphonates during study treatment
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland,   Ireland,   Sweden
 
NCT00255606
AVENTIS-FIN-1-2003, CDR0000442891, FINNISH-URO-OGS-1-2003, PROSTY-FIN-1-2003, ICORG-06-14-Prosty, EU-20891
Not Provided
Not Provided
University of Tampere
Not Provided
Principal Investigator: Pirkko Kellokumpu-Lehtinen Tampere University Hospital
National Cancer Institute (NCI)
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP