No registrations found.
Source
Brief title
Health condition
Prostate cancer
Sponsors and support
Ipsen BV
Intervention
No registrations found.
Outcome measures
Primary outcome
Survival.
Secondary outcome
1. Biochemical progression;
2. Health related quality of life.
Background 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.
Study objective
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.
Study design
NA
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).
Department of Urology,
P.O. Box 95500
G. Andel, van
Oosterpark 9
Amsterdam 1090 HM
The Netherlands
-
g.v.andel@wxs.nl
Department of Urology,
P.O. Box 95500
G. Andel, van
Oosterpark 9
Amsterdam 1090 HM
The Netherlands
-
g.v.andel@wxs.nl
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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL234 |
NTR-old | NTR271 |
Other | - : N/A |
ISRCTN | ISRCTN06890529 |