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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
docetaxel
prednisone
Sponsored by
Tampere University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Helsinki University Central Hospital
  • Kainuu Central Hospital
  • Keski-Pohjanmaa Central Hospital
  • Kymenlaakso Central Hospital
  • Tampere University Hospital
  • Oulu University Hospital
  • Satakunta Central Hospital
  • Tampere University Hospital
  • Turku University Central Hospital
  • Bons Secours Hospital
  • Mercy University Hospital
  • Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
  • Mater Misericordiae University Hospital
  • St. James's Hospital
  • Beaumont Hospital
  • Galway University Hospital
  • Mid-Western Cancer Centre at Mid-Western Regional Hospital
  • Karlstad Central Hospital
  • Karolinska University Hospital - Solna

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I

Arm II

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Time to treatment failure (TTF)

Secondary Outcome Measures

Quality of life every 6 weeks until TTF
Safety
Overall survival
Response rate
Use of epoetin beta

Full Information

First Posted
November 18, 2005
Last Updated
June 25, 2013
Sponsor
Tampere University
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1. Study Identification

Unique Protocol Identification Number
NCT00255606
Brief Title
Docetaxel and Prednisone in Treating Patients With Hormone-Refractory Metastatic Prostate Cancer
Official Title
A Phase III Trial Comparing Docetaxel Every Third Week to Biweekly Docetaxel Monotherapy in Metastatic Hormone Refractory Prostate Cancer Patients - PROSTY Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Tampere University

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
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 Title
Arm II
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Description
Given in 3- or 4- week courses
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Description
Given in 3- or 4- week courses
Primary Outcome Measure Information:
Title
Time to treatment failure (TTF)
Secondary Outcome Measure Information:
Title
Quality of life every 6 weeks until TTF
Title
Safety
Title
Overall survival
Title
Response rate
Title
Use of epoetin beta

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pirkko Kellokumpu-Lehtinen
Organizational Affiliation
Tampere University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
FIN-00029
Country
Finland
Facility Name
Kainuu Central Hospital
City
Kajaani
ZIP/Postal Code
87140
Country
Finland
Facility Name
Keski-Pohjanmaa Central Hospital
City
Kokkola
ZIP/Postal Code
67200
Country
Finland
Facility Name
Kymenlaakso Central Hospital
City
Kotka
ZIP/Postal Code
48210
Country
Finland
Facility Name
Tampere University Hospital
City
Lahti
ZIP/Postal Code
15850
Country
Finland
Facility Name
Oulu University Hospital
City
Oulu
ZIP/Postal Code
FIN-90014
Country
Finland
Facility Name
Satakunta Central Hospital
City
Pori
ZIP/Postal Code
28500
Country
Finland
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Facility Name
Turku University Central Hospital
City
Turku
ZIP/Postal Code
FIN-20521
Country
Finland
Facility Name
Bons Secours Hospital
City
Cork
Country
Ireland
Facility Name
Mercy University Hospital
City
Cork
Country
Ireland
Facility Name
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
City
Dublin
ZIP/Postal Code
24
Country
Ireland
Facility Name
Mater Misericordiae University Hospital
City
Dublin
ZIP/Postal Code
7
Country
Ireland
Facility Name
St. James's Hospital
City
Dublin
ZIP/Postal Code
8
Country
Ireland
Facility Name
Beaumont Hospital
City
Dublin
ZIP/Postal Code
9
Country
Ireland
Facility Name
Galway University Hospital
City
Galway
Country
Ireland
Facility Name
Mid-Western Cancer Centre at Mid-Western Regional Hospital
City
Limerick
ZIP/Postal Code
0009
Country
Ireland
Facility Name
Karlstad Central Hospital
City
Karlstad
ZIP/Postal Code
65185
Country
Sweden
Facility Name
Karolinska University Hospital - Solna
City
Stockholm
ZIP/Postal Code
S-171 76
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
23294853
Citation
Kellokumpu-Lehtinen PL, Harmenberg U, Joensuu T, McDermott R, Hervonen P, Ginman C, Luukkaa M, Nyandoto P, Hemminki A, Nilsson S, McCaffrey J, Asola R, Turpeenniemi-Hujanen T, Laestadius F, Tasmuth T, Sandberg K, Keane M, Lehtinen I, Luukkaala T, Joensuu H; PROSTY study group. 2-Weekly versus 3-weekly docetaxel to treat castration-resistant advanced prostate cancer: a randomised, phase 3 trial. Lancet Oncol. 2013 Feb;14(2):117-24. doi: 10.1016/S1470-2045(12)70537-5. Epub 2013 Jan 4.
Results Reference
derived
PubMed Identifier
22399616
Citation
Hervonen P, Joensuu H, Joensuu T, Ginman C, McDermott R, Harmenberg U, Nyandoto P, Luukkaala T, Hemminki A, Zaitsev I, Heikkinen M, Nilsson S, Luukkaa M, Lehtinen I, Kellokumpu-Lehtinen PL. Biweekly docetaxel is better tolerated than conventional three-weekly dosing for advanced hormone-refractory prostate cancer. Anticancer Res. 2012 Mar;32(3):953-6. Erratum In: Anticancer Res. 2012 Sep;32(9):4169. multiple author names corrected.
Results Reference
derived

Learn more about this trial

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

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