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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29395

Enrollment

446

Registered

2005-09-08

Start date

2004-11-27

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer

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).

Eligibility

Inclusion criteria

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

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 80 year; 6. Participation in on other protocol; 7. Not capable of filling out Quality of Life Questionnaires.

Design outcomes

Primary

Measure	Time frame
Survival.	—

Secondary

Measure	Time frame
1. Biochemical progression; 2. Health related quality of life.	—

Contacts

Public ContactG. Andel, van

Onze Lieve Vrouwe Gasthuis (OLVG), Department of Urology, P.O. Box 95500

g.v.andel@wxs.nl-

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)