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
Protocol serial number	NTR469; EMC 03-146
Sponsor	Erasmus Medical Centre (Netherlands)
Funders	Sanofi-Aventis B.V. (Netherlands), Erasmus Medical Centre (Netherlands) (added 10/08/09)

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

Erasmus Medical Center Rotterdam
Department of Medical Oncology
P.O. Box 5201
Rotterdam
3008 AE
Netherlands

Study information

Primary study design	Interventional
Study design	Multicentre randomised open label active controlled parallel group trial
Secondary study design	Randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	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
Completion date	01/01/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan