Condition category
Cancer
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
14/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr R de Wit

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR469; EMC 03-146

Study information

Scientific title

Acronym

NePro

Study 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.

Ethics approval

Received from local medical eithics committee

Study design

Multicentre randomised open label active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

15/12/2003

Overall trial end date

01/01/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

480

Participant 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

Recruitment start date

15/12/2003

Recruitment end date

01/01/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Center Rotterdam
Rotterdam
3008 AE
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre (Netherlands)

Sponsor details

Postbus 2040
Rotterdam
3000 CA
Netherlands

Sponsor type

University/education

Website

http://www.erasmusmc.nl

Funders

Funder type

Industry

Funder name

Sanofi-Aventis B.V. (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Erasmus Medical Centre (Netherlands) (added 10/08/09)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes