|- candidate number||1784|
|- NTR Number||NTR469|
|- Date ISRCTN created||27-jan-2006|
|- date ISRCTN requested||18-nov-2005|
|- Date Registered NTR||24-okt-2005|
|- Secondary IDs||EMC 03-146 |
|- Public Title||Randomized phase II/III study of Risedronate in combination with Docetaxel versus Docetaxel alone in patients with hormone refractory prostate cancer.|
|- Scientific Title||Randomized phase II/III study of Risedronate in combination with Docetaxel versus Docetaxel alone in patients with hormone refractory prostate cancer.|
|- hypothesis||Clinical studies with mitoxantrone and clodronate showed a better pain reduction in patients with prostate cancer. Both in vitro and animal studies have shown that paclitaxel and biphosphonates act synergistically and prevent formation and progression of bone metastasis (breast cancer). This clinical trial studies the effect of risedronate and docetaxel in the treatment of hormone refractory prostate cancer.|
|- Healt Condition(s) or Problem(s) studied||Prostate cancer|
|- 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||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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||15-dec-2003|
|- planned closingdate||1-jan-2007|
|- Target number of participants||480|
|- 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 mg bid.
Treatment will be given until progression, or 10 courses. After progression Risedronate 30 mg od + prednisone 5 mg will be continued.
|- Primary outcome||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 outcome||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|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Dr. R. Wit, de|
|- CONTACT for SCIENTIFIC QUERIES||Dr. R. Wit, de|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center, Sanofi-Aventis|
|- Brief summary||N/A|
|- Main changes (audit trail)|
|- RECORD||24-okt-2005 - 4-nov-2009|