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
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: docetaxel
Drug: prednisone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Phase III Trial Comparing Docetaxel Every Third Week to Biweekly Docetaxel Monotherapy in Metastatic Hormone Refractory Prostate Cancer Patients - PROSTY Trial

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Time to treatment failure (TTF) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 360
Study Start Date: August 2005
Study Completion Date: August 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: docetaxel
Given in 3- or 4- week courses
Drug: prednisone
Given in 3- or 4- week courses
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.
Drug: docetaxel
Given in 3- or 4- week courses
Drug: prednisone
Given in 3- or 4- week courses

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00255606

Locations
Finland
Helsinki University Central Hospital
Helsinki, Finland, FIN-00029
Kainuu Central Hospital
Kajaani, Finland, 87140
Keski-Pohjanmaa Central Hospital
Kokkola, Finland, 67200
Kymenlaakso Central Hospital
Kotka, Finland, 48210
Tampere University Hospital
Lahti, Finland, 15850
Oulu University Hospital
Oulu, Finland, FIN-90014
Satakunta Central Hospital
Pori, Finland, 28500
Tampere University Hospital
Tampere, Finland, 33521
Turku University Central Hospital
Turku, Finland, FIN-20521
Ireland
Mercy University Hospital
Cork, Ireland
Bons Secours Hospital
Cork, Ireland
Beaumont Hospital
Dublin, Ireland, 9
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
Dublin, Ireland, 24
Mater Misericordiae University Hospital
Dublin, Ireland, 7
St. James's Hospital
Dublin, Ireland, 8
Galway University Hospital
Galway, Ireland
Mid-Western Cancer Centre at Mid-Western Regional Hospital
Limerick, Ireland, 0009
Sweden
Karlstad Central Hospital
Karlstad, Sweden, 65185
Karolinska University Hospital - Solna
Stockholm, Sweden, S-171 76
Sponsors and Collaborators
University of Tampere
Investigators
Principal Investigator: Pirkko Kellokumpu-Lehtinen Tampere University Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00255606     History of Changes
Other Study ID Numbers: AVENTIS-FIN-1-2003, CDR0000442891, FINNISH-URO-OGS-1-2003, PROSTY-FIN-1-2003, ICORG-06-14-Prosty, EU-20891
Study First Received: November 18, 2005
Last Updated: June 25, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
stage IV prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Prednisone
Docetaxel
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 20, 2014