Clinical trial · Interventional
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
NCT00255606CI-TRIAL-00011059completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| prednisone | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- 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.
- interventionNames
- Drug: docetaxel
- Drug: prednisone
- type
- EXPERIMENTAL
- label
- Arm II
- 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.
- interventionNames
- Drug: docetaxel
- Drug: prednisone
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDKellokumpu-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
- DERIVEDHervonen 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