No registrations found.
ID
Source
Brief title
Sponsors and support
Intervention
Outcome measures
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
Background summary
N/A
Study objective
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.
Study design
N/A
Intervention
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.
P.O. Box 5201
R. Wit, de
Rotterdam 3008 AE
The Netherlands
r.dewit@erasmusmc.nl
P.O. Box 5201
R. Wit, de
Rotterdam 3008 AE
The Netherlands
r.dewit@erasmusmc.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL429 |
| NTR-old | NTR469 |
| Other | : EMC 03-146 |
| ISRCTN | ISRCTN22844568 |