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
| ISRCTN | ISRCTN06890529 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06890529 |
| Protocol serial number | NTR271 |
| Sponsor | Onze Lieve Vrouwe Gasthuis (OLVG) (The Netherlands) |
| Funders | AstraZeneca (The Netherlands), Ipsen Fund |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 11/10/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Onze Lieve Vrouwe Gasthuis (OLVG)
Department of Urology
P.O. Box 95500
Amsterdam
1090 HM
Netherlands
| g.v.andel@wxs.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised active-controlled parallel-group trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Study acronym | HORRAD |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | LHRH analogue |
| Primary outcome measure(s) |
Survival |
| Key secondary outcome measure(s) |
1. Biochemical progression |
| Completion date | 01/07/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 425 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 27/11/2004 |
| Date of final enrolment | 04/09/2014 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
1090 HM
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data sharing plans for the current study are unknown and will 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 |
Editorial Notes
11/10/2018: Publication reference added.
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.
