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The effects of neoadjuvant hormonal therapy on the course of PSA and testosterone in patients with low and intermediate risk prostate carcinoma (NEO-ONE)

The effects of neoadjuvant hormonal therapy on the course of PSA and testosterone in patients with low and intermediate risk prostate carcinoma (NEO-ONE) - NHT influence on PSA and testosterone after brachytherapy (NEO-ONE)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON39212
Enrollment
400
Registered
2011-11-15
Start date
2012-02-01
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

prostate carcinoma

Interventions

The treatment group is given androgen blockage using Eligard 22.5 mg once and Bicalutamide 50 mg daily for the duration of three months preceding BT. The control group will receive BT immediately.

Sponsors

TweeSteden ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: These are the inclusioncriteria: Patients with low and intermediate risk prostate cancer (according to Dutch guidelines) prostate volume between 35 and 55 cc a life expectancy of at least 10 years written informed consent

Exclusion criteria

Exclusion criteria: These are the exclusion criteria: Contra-indication for BT use of hormone suppressive therapy in the past or surgical castration. use of 5 alfa reductase in the last 6 months use of estrogens cognitive impairments negative decision for study participation by the hospitals* urology-radiotherapy meeting kidney or liver dysfunction history of myocardial infarction with present symptoms or CAD-induced heart failure

Design outcomes

Primary

MeasureTime frame
Levels of PSA and testosterone over the 3-year follow-up period;

Secondary

MeasureTime frame
change in prostate volume+ other important variables: age, urinary complaints, complications, events.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)