Condition category
Cancer
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
12/08/2014
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 G van Andel

ORCID ID

Contact details

Onze Lieve Vrouwe Gasthuis (OLVG)
Department of Urology
P.O. Box 95500
Amsterdam
1090 HM
Netherlands
g.v.andel@wxs.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR271

Study information

Scientific title

Acronym

HORRAD

Study hypothesis

Today the standard therapy for patients primary diagnosed with M+ prostate cancer (bone metastasis) is systemic hormonal therapy. If standard hormonal treatment will be combined with local external radiation therapy of the prostate the survival may improve.

Ethics approval

Received from the local medical ethics committee

Study design

Multicentre randomised active-controlled parallel-group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Prostate cancer

Intervention

Group 1 will be hormonally treated with a LHRH analogue
Group 2 will be hormonally treated with a LHRH analogue in combination with local external radiation therapy of the prostate (70 Gray)

Joint sponsor:
Erasmus Medical Centre (The Netherlands)
Department of Urology
P.O. Box 1738
Rotterdam, 3000 RD
The Netherlands

Intervention type

Drug

Phase

Not Applicable

Drug names

LHRH analogue

Primary outcome measures

Survival

Secondary outcome measures

1. Biochemical progression
2. Health-related quality of life

Overall trial start date

01/12/2004

Overall trial end date

01/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically proven adenocarcinoma of the prostate
2. Stage T1-4, G1-3, N0-2, M1
3. Bone metastases diagnosed with a bonescan

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

500

Participant exclusion criteria

1. Start therapy more than 8 weeks after the initial diagnoses
2. Other treatment for prostate cancer before start of the study therapy
3. Other malignancies except skin carcinoma
4. Prostate specific antigen (PSA) less than 20 ng/ml
5. Aged greater than 80 years
6. Participation in another protocol
7. Not capable of filling out quality of life questionnaires

Recruitment start date

01/12/2004

Recruitment end date

01/12/2011

Locations

Countries of recruitment

Netherlands

Trial participating centre

Onze Lieve Vrouwe Gasthuis (OLVG)
Amsterdam
1090 HM
Netherlands

Sponsor information

Organisation

Onze Lieve Vrouwe Gasthuis (OLVG) (The Netherlands)

Sponsor details

Department of Urology
P.O. Box 95500
Amsterdam
1090 HM
Netherlands
+31 (0)20 599 9111
informatie@olvg.nl

Sponsor type

Hospital/treatment centre

Website

http://www.olvg.nl/

Funders

Funder type

Industry

Funder name

AstraZeneca (The Netherlands)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

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