Condition category
Cancer
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
23/01/2018
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

A randomised study about the effect on survival of hormonal therapy versus hormonal therapy plus local external radiation therapy in patients with primary diagnosed metastasised (M+) prostate cancer

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

01/11/2004

Overall trial end date

01/07/2017

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

425

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

27/11/2004

Recruitment end date

04/09/2014

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

Funder name

Ipsen Fund

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/06/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

23/01/2018: The following changes have been made: 1. After a planned interim analysis by an independent data-management safely board in 2011, the target number of participants has been changed from 500 to 425. 446 patients are assessed for eligibility. 2. Ipsen was added as a funder 3. The overall trial dates have been updated from 01/12/2004-01/12/2011 to 01/11/2004-01/07/2017. 4. The recruitment dates have been updated from 01/12/2004-01/12/2011 to 27/11/2004-04/09/2014. 5. The intention to publish date has been added. 6. The publication and dissemination plans have been added. 7. The participant level data sharing statement has been added.