Pilot study: clinical evaluation of biomarkers as predictors of survival in castrate-resistant prostate cancer patients.

Pilot study: clinical evaluation of biomarkers as predictors of survival in castrate-resistant prostate cancer patients. - BOSS - Biomarker Overall Survival Study in CRPC patients

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON34838

Enrollment

Registered

2010-06-14

Start date

2010-07-28

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Castrate-Resistant Prostate Cancer (CRPC)

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed prostate cancer 2. Either biological recurrence (2 consecutive increases in the PSA level after the nadir, with a minimum 2 week interval between measurements) and/or radiological recurrence (new osseous lesions and/or new or enlarged soft tissue metastases) 3. Testosterone 5 ng/mL 5. ECOG performance status of 0-2 6. Starting first course docetaxel-based chemotherapy treatment

Exclusion criteria

Exclusion criteria: Within 4 wk of entry use of an antiandrogen (6wk for nilutamide and bicalutamide). Within 30 days of entry radiation or radionuclide therapy.

Design outcomes

Primary

Measure	Time frame
The primary endpoint of this study will be Overall Survival (OS).	—

Secondary

Measure	Time frame
The secondary endpoint of this study will be biochemical and/or radiological recurrence of disease.	—

Countries

Netherlands

Outcome results