Contact information
Type
Scientific
Contact name
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/CTIS number
IRAS 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(s)
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
Study setting(s)
Hospital
Study 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
Pharmaceutical study type(s)
Phase
Not Applicable
Drug/device/biological/vaccine name(s)
LHRH analogue
Primary outcome measure
Survival
Secondary outcome measures
1. Biochemical progression
2. Health-related quality of life
Overall study start date
01/11/2004
Overall study end date
01/07/2017
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Sex
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
Study 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
ROR
Funders
Funder type
Industry
Funder name
AstraZeneca (The Netherlands)
Alternative name(s)
AstraZeneca PLC, Pearl Therapeutics
Funding Body Type
government organisation
Funding Body Subtype
For-profit companies (industry)
Location
United Kingdom
Funder name
Ipsen Fund
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
Intention to publish date
01/06/2018
Individual participant data (IPD) sharing plan
The data sharing plans for the current study are unknown and will be made available at a later date.
IPD sharing plan summary
Data sharing statement to be made available at a later date
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | survival results | 01/03/2019 | Yes | No |