Observational Cohort Study of Patients With Castration-Resistant Prostate Cancer (CRPC) (TRUMPET)

Astellas

Status: Completed

Conditions: Metastatic Prostate Cancer; Castration-resistant Prostate Cancer; Prostate Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT02380274

ONC-MA-1004

Details and patient eligibility

About

The purpose of this study is to describe patterns of care in CRPC patients, as well as health-related quality of life (HRQoL) outcomes associated with CRPC and its management.

This study will also describe factors influencing treatment decisions including reason(s) for treatment choices and triggers for treatment changes for CRPC as well as describe clinical outcomes based on patient characteristics.

Enrollment: 1,030 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patient Inclusion:

• Patient may have M0 or M1 disease
• Confirmed diagnosis of CRPC defined by both Testosterone at castrate levels, as evidenced by a serum testosterone level ≤ 1.73 nmol/L (50 ng/dL) and Clear progressive disease, as evidenced by a minimum of two rising PSA levels measured at least 7 days apart or new clinical or imaging evidence of progressive metastatic disease
• Initiating the first or second line treatment for CRPC: including anti- androgens, androgen synthesis inhibitors, chemotherapy, immunotherapy or radionuclide therapy. Previous first line CRPC treatments are limited to: First generation anti-androgens (bicalutamide, flutamide, or nilutamide) or Sipuleucel-T
• Patients may be enrolled within 90 days from the time of decision to treat or within 90 days of treatment initiation.
• Willing and able to complete periodic patient-reported outcome (PRO) questionnaires, with or without assistance
• Estimated life expectancy of ≥ 6 months

Caregiver Inclusion:

• Meets the definition of an unpaid relative or friend who helps the patient with his or her activities of daily living
• Willing and able to complete caregiver-reported outcome questionnaires over the course of the patient's participation in the study

Exclusion criteria

Patient Exclusion:

• Receiving concomitant treatment for other cancer (excluding basal cell carcinoma, squamous cell carcinoma and treatment for hormone sensitive prostate cancer) within 6 months prior to enrollment.

Trial design

1,030 participants in 1 patient group

Patients with CRPC

Description:

Patients with CRPC