None listed
Conditions
Interventions
Arm A. Docetaxel 75mg/m2 every 3 weeks. Every patient will receive prednison 5 mg bid.
Arm B. Docetaxel 75mg/m2 every 3 weeks plus 30 mg Risedronate once daily. Every patient will receive prednison 5
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically proven prostate adenocarcinoma; 2. Hormone refractory; 3. Continued elevated PSA for at least 6 weeks after discontinuation of anti-androgens prior to registration; 4. Last PSA level > 5 ng/ml; 5. Stable analgesic regimen for at least one week prior to registration; 6. Patients without surgical castration must continue on LHRH antogonists; 7. Adequate bone marrow, liver, renal funtion; 8. WHO 0-2.
Exclusion criteria
Exclusion criteria: 1. Previous or concomitant use of biphosphonates; 2. Prior chemotherapy or radiotherapy within 4 weeks prior to treatment start; 3. Uncontrolled hypercalcemia; 4. Brain metastases; 5. Previous or concomitant malignancies; 6. Uncontrolled systemic disease of infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of phase II part is to assess the objective PSA response to treatment by serial measurements of serum PSA as defined by the "Bubley". Primary objectives phase III study is to compare time to progression between concomitant and sequential use of docetaxel and risedronate, in combination with prednison. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives phase II are to assess the toxicity profile, objective response (RECIST) and duration of PSA reponse. Seondary objectives phase III study is to compare the following paramaters: PSA reponse (Nubley rate), PPI according to McGIll-Melzack toxicity profile, objective response (RECIST), duration of PSA response, survival | — |
Contacts
Public ContactR. Wit, de
Erasmus Medical Center Rotterdam, Department of Medical Oncology, P.O. Box 5201
Outcome results
None listed