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…
Bron
Verkorte titel
Aandoening
Prostate cancer
Ondersteuning
Ipsen BV
Onderzoeksproduct en/of interventie
Geen registraties gevonden.
Uitkomstmaten
Primaire uitkomstmaten
Survival.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
NA
Onderzoeksproduct en/of interventie
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).
Publiek
Department of Urology,
P.O. Box 95500
G. Andel, van
Oosterpark 9
Amsterdam 1090 HM
The Netherlands
-
g.v.andel@wxs.nl
Wetenschappelijk
Department of Urology,
P.O. Box 95500
G. Andel, van
Oosterpark 9
Amsterdam 1090 HM
The Netherlands
-
g.v.andel@wxs.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Histologically proven adenocarcinoma of the prostate;
2. Stage T1-4, G1-3, N0-2, M1;
3. Bonemetastases diagnosed with a bonescan.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL234 |
NTR-old | NTR271 |
Ander register | - : N/A |
ISRCTN | ISRCTN06890529 |