Randomized phase II/III study of Risedronate in combination with Docetaxel versus Docetaxel alone in patients with hormone refractory prostate cancer
| ISRCTN | ISRCTN22844568 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22844568 |
| Secondary identifying numbers | NTR469; EMC 03-146 |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 14/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr R de Wit
Scientific
Scientific
Erasmus Medical Center Rotterdam
Department of Medical Oncology
P.O. Box 5201
Rotterdam
3008 AE
Netherlands
Study information
| Study design | Multicentre randomised open label active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | NePro |
| Study objectives | 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. |
| Ethics approval(s) | Received from local medical eithics committee |
| Health condition(s) or problem(s) studied | Prostate Cancer |
| Intervention | Arm A: Docetaxel 75 mg/m2 every 3 weeks. Every patient will receive prednisone 5 mg bid. Arm B: Docetaxel 75 mg/m2 every 3 weeks plus 30 mg Risedronate once daily. Every patient will receive prednisone 5 mg bid. Treatment will be given until progression, or 10 courses. After progression Risedronate 30 mg od + prednisone 5 mg will be continued. |
| Intervention type | Other |
| Primary outcome measure | 1. Assess the objective PSA response to treatment by serial measurements of serum PSA as defined by the 'Bubley'. 2. Compare time to progression between concomitant and sequential use of docetaxel and risedronate, in combination with prednisone. |
| Secondary outcome measures | Compare the following parameters: 1. PSA response (Nubley rate) 2. PPI according to McGIll-Melzack toxicity profile 3. Objective response (RECIST) 4. Duration of PSA response 5. Survival |
| Overall study start date | 15/12/2003 |
| Completion date | 01/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 480 |
| Key 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; last PSA level >5 ng/ml 4. Stable analgesic regimen for at least one week prior to registration 5. Patients without surgical castration must continue on LHRH antagonists 6. Adequate bone marrow, liver, renal function 7. WHO 0-2 |
| Key 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 |
| Date of first enrolment | 15/12/2003 |
| Date of final enrolment | 01/01/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Center Rotterdam
Rotterdam
3008 AE
Netherlands
3008 AE
Netherlands
Sponsor information
Erasmus Medical Centre (Netherlands)
University/education
University/education
Postbus 2040
Rotterdam
3000 CA
Netherlands
| Website | http://www.erasmusmc.nl |
|---|---|
"ROR" |
https://ror.org/018906e22 |
Funders
Funder type
Industry
Sanofi-Aventis B.V. (Netherlands)
No information available
Erasmus Medical Centre (Netherlands) (added 10/08/09)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
