|- candidate number||1467|
|- NTR Number||NTR271|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||8-sep-2005|
|- Secondary IDs||N/A |
|- Public 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.
|- 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||the 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.|
|- Healt Condition(s) or Problem(s) studied||Prostate cancer|
|- Inclusion criteria||1. Histologically proven adenocarcinoma of the prostate;|
2. Stage T1-4, G1-3, N0-2, M1;
3. Bonemetastases diagnosed with a bonescan.
|- Exclusion criteria||1. 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 received||yes|
|- multicenter trial||yes|
|- planned startdate ||1-dec-2004|
|- planned closingdate||1-dec-2011|
|- Target number of participants||500|
|- Interventions||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).
|- Primary outcome||Survival.|
|- Secondary outcome||1. Biochemical progression;|
2. Health related quality of life.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. G. Andel, van|
|- CONTACT for SCIENTIFIC QUERIES||Dr. G. Andel, van|
|- Sponsor/Initiator ||Onze Lieve Vrouwe Gasthuis (OLVG), Department of Urology, Erasmus Medical Center, Department of Urology|
(Source(s) of Monetary or Material Support)
|- Brief summary||Today 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)|
|- RECORD||10-sep-2005 - 21-dec-2006|