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

NCT00255606 | Completed Phase 3

• 6 other identifiers: AVENTIS-FIN-1-2003CDR0000442891FINNISH-URO-OGS-1-2003PROSTY-FIN-1-2003ICORG-06-14-ProstyEU-20891
• Study Type: interventional
• Target: 360
• Locations: 3 countries
• Sites: 19

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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage IV prostate cancer; recurrent prostate cancer

Outcome Measures

Primary Outcomes (1)

• Time to treatment failure (TTF)

Secondary Outcomes (5)

• Quality of life every 6 weeks until TTF

• Safety

• Overall survival

• Response rate

• Use of epoetin beta

Study Arms (2)

Arm I

EXPERIMENTAL

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; Drug: prednisone

Arm II

EXPERIMENTAL

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; Drug: prednisone

Interventions

docetaxel DRUG

Given in 3- or 4- week courses

Arm I; Arm II

prednisone DRUG

Given in 3- or 4- week courses

Arm I; Arm II

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Tampere University: lead

Study Sites (19)

Helsinki University Central Hospital

Helsinki, FIN-00029, Finland

Location

Kainuu Central Hospital

Kajaani, 87140, Finland

Location

Keski-Pohjanmaa Central Hospital

Kokkola, 67200, Finland

Location

Kymenlaakso Central Hospital

Kotka, 48210, Finland

Location

Tampere University Hospital

Lahti, 15850, Finland

Location

Oulu University Hospital

Oulu, FIN-90014, Finland

Location

Satakunta Central Hospital

Pori, 28500, Finland

Location

Tampere University Hospital

Tampere, 33521, Finland

Location

Turku University Central Hospital

Turku, FIN-20521, Finland

Location

Bons Secours Hospital

Cork, Ireland

Location

Mercy University Hospital

Cork, Ireland

Location

Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital

Dublin, 24, Ireland

Location

Mater Misericordiae University Hospital

Dublin, 7, Ireland

Location

St. James's Hospital

Dublin, 8, Ireland

Location

Beaumont Hospital

Dublin, 9, Ireland

Location

Galway University Hospital

Galway, Ireland

Location

Mid-Western Cancer Centre at Mid-Western Regional Hospital

Limerick, 0009, Ireland

Location

Karlstad Central Hospital

Karlstad, 65185, Sweden

Location

Karolinska University Hospital - Solna

Stockholm, S-171 76, Sweden

Location

Related Publications (2)

• 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.

  PMID: 23294853 DERIVED

• 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.

  PMID: 22399616 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; Prednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Pirkko Kellokumpu-Lehtinen

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 18, 2005
• First Posted: November 21, 2005
• Study Start: August 1, 2005
• Primary Completion: May 1, 2009
• Study Completion: August 1, 2010
• Last Updated: June 26, 2013

Record last verified: 2010-09

Locations

SE (2); IE (8); FI (9)