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Randomized phase II/III study of Risedronate in combination with Docetaxel versus Docetaxel alone in patients with hormone refractory prostate cancer.


- candidate number1784
- NTR NumberNTR469
- ISRCTNISRCTN22844568
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR24-okt-2005
- Secondary IDsEMC 03-146 
- Public TitleRandomized phase II/III study of Risedronate in combination with Docetaxel versus Docetaxel alone in patients with hormone refractory prostate cancer.
- Scientific TitleRandomized phase II/III study of Risedronate in combination with Docetaxel versus Docetaxel alone in patients with hormone refractory prostate cancer.
- ACRONYMNePro
- hypothesisClinical 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) studiedProstate cancer
- Inclusion criteria1. 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 criteria1. 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 receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type[default]
- Studytypeintervention
- planned startdate 15-dec-2003
- planned closingdate1-jan-2007
- Target number of participants480
- InterventionsArm 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 outcomeThe 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 outcomeSecondary 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
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. R. Wit, de
- CONTACT for SCIENTIFIC QUERIESDr. R. Wit, de
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, Sanofi-Aventis
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD24-okt-2005 - 4-nov-2009


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