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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.


- candidate number1467
- NTR NumberNTR271
- ISRCTNISRCTN06890529
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR8-sep-2005
- Secondary IDsN/A 
- Public TitleA 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.
- Scientific TitleA 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.
- ACRONYMthe HORRAD study
- hypothesisToday 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.
- Healt Condition(s) or Problem(s) studiedProstate cancer
- Inclusion criteria1. Histologically proven adenocarcinoma of the prostate;
2. Stage T1-4, G1-3, N0-2, M1;
3. Bonemetastases diagnosed with a bonescan.
- Exclusion criteria1. Start therapy more than 8 weeks after the initial diagnoses;
2. Other treatment for prostate cancer before start of the studytherapy;
3. Other mailignancies except skincarcinoma;
4. PSA < 20 ng/ml;
5. Age > 80 year;
6. Participation in on other protocol;
7. Not capable of filling out Quality of Life Questionnaires.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-dec-2004
- planned closingdate1-dec-2011
- Target number of participants500
- InterventionsGroup 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).
- Primary outcomeSurvival.
- Secondary outcome1. Biochemical progression;
2. Health related quality of life.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. G. Andel, van
- CONTACT for SCIENTIFIC QUERIESDr. G. Andel, van
- Sponsor/Initiator Onze Lieve Vrouwe Gasthuis (OLVG), Department of Urology, Erasmus Medical Center, Department of Urology
- Funding
(Source(s) of Monetary or Material Support)
AstraZeneca
- PublicationsN/A
- Brief summaryToday the standard therapy for patients primarily diagnosed with M+ prostate cancer (bone metastases) is systemic hormonal treatment. There are a few studies published indicating that patients with N+ prostate cancer (lymphnode metastases) have survival benefit from combined local and systemic therapy. In metastasised renal cell carcinoma there are two studies showing a survival benefit for combined local and systemic therapy compared with systemic therapy only.
This concept has never been studied in M+ prostate cancer.
The main objective of the present study is to investigate whether combined systemic hormonal and local radiation therapy will improve the survival in primarily diagnosed M+ prostate cancer patients.
In this multicentre study 500 patients will be entered, randomised for treatment with a LHRH analogue or for treatment with a LHRH analogue plus local external radiation therapy of the prostate (70 Gray).
The primary outcome is survival and the secundary are biochemical progression and health related quality of life.
- Main changes (audit trail)
- RECORD10-sep-2005 - 21-dec-2006


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