Positive Imaging Study for Distant Metastases in Patients With Castration-Resistant Prostate Cancer (PREDICT)

Dendreon

Status: Terminated

Conditions: Castration-Resistant Prostate Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT01981109

P12-1

Details and patient eligibility

About

The primary purpose of this research is to describe patient characteristics predictive of an imaging study positive for distant metastases in patients with castration-resistant prostate cancer and no known distant metastases.

Enrollment: 225 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent obtained prior to the initiation of study procedures.
• Men ≥ 18 years of age.
• Histologically documented prostatic adenocarcinoma.
• History of Castration-Resistant Prostate Cancer.

Exclusion criteria

• Known M1 disease.
• Undergone imaging study for metastatic prostate cancer ≤ 3 months.
• ECOG performance status ≥ 3.
• Known malignant pleural effusions or ascites.
• Current or prior treatment with investigational therapy for M0 Castration-Resistant Prostate Cancer (Taxotere (docetaxel), Provenge® (sipuleucel-T), Zytiga (abiraterone acetate), Xtandi (enzalutamide), Jevtana (cabazitaxel), or Xofigo (radium Ra 223 dichloride).

Trial design