Radiotherapy with or without ibandronate in the treatment of painful bone metastases of prostate cancer

ISRCTN	ISRCTN55471205
DOI	https://doi.org/10.1186/ISRCTN55471205
Protocol serial number	N/A
Sponsor	Erasmus Medical Center (The Netherlands)
Funder	Roche Nederland BV

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

Dr L. Incrocci
Scientific

Erasmus Medical Center
Daniel den Hoed Cancer Center
P.O. Box 5201
Rotterdam
3008 AE
Netherlands

Phone	+31 (0)10 4391421
Email	l.incrocci@erasmusmc.nl

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	The purpose of this study is to evaluate the efficacy of oral ibandronate (versus placebo) added to the standard radiotherapy regimen for painful bone metastases to reduce pain, to reduce the need of analgesics, and to reduce skeletal-related events (impending fractures, need of repeated radiotherapy, or surgery).
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Prostate Cancer
Intervention	Ibandronate tablet or placebo
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	ibandronate
Primary outcome measure(s)	Primary objective will be pain reduction on the pain scale (scale 0-10) at 12 weeks of treatment. Response of treatment will be defined as a reduction of at least two points of the pain scale.
Key secondary outcome measure(s)	1. Pain reduction on the pain scale at 4-8-16-20-24 weeks of treatment. Use of analgesics at 4-8-12-16-20-24 weeks of treatment. 2. New skeletal-related events (= time to progression, including fractures, need of repeated radiotherapy, surgery) 3. Side effects at 4-8-12-16-20-24 weeks of treatment 4. Quality of Life, as measured by the EORTC-QLQ-C30 and EQ-5D, at 12-24 weeks
Completion date	01/12/2007

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	80
Key inclusion criteria	1. Karnofsky score >60% 2. Written informed consent 3. Histologically proven PC with documented (bone scintigraphy, CT scan, MRI, or conventional X-Ray) bone metastases, without spinal cord/cauda equina compression 4. Indication for analgesic radiotherapy 5. Estimated life expectancy of >6 months 6. Clinically documented painful bone metastases 7. Indication for analgesic radiotherapy for the painful bone metastases
Key exclusion criteria	1. Previous treatment with any kind of bisphosphonates or radionuclides 2. Hypercalcemia (serum calcium level >2.65 mmol/l), hypocalcemia (serum calcium level <2.2 mmol/l), impaired renal function (creatinine >266 µmol/l; albumin >50 g/l), according to the medical charts 3. Investigational drugs within 30 days before study entry 4. Paget's disease 5. Untreated esophagitis or gastric ulcer
Date of first enrolment	01/12/2005
Date of final enrolment	01/12/2007

Erasmus Medical Center

Rotterdam
3008 AE
Netherlands

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