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TerminatedNCT01076751PORTREATUpdated Feb 14, 2011

Observational Registry of Treatment Patterns in Castrate-resistant Prostate Cancer (CRPC) Patients

An observational study in Prostatic Neoplasms, sponsored by Sanofi. Terminated at 5 sites in 5 countries. Open to male participants. Per ClinicalTrials.gov, last updated 2011-02-14.

Sponsored by Sanofi · Observational

Why this study was terminated
delay in recruitment
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
82
Sex
Male
01

Study summary

Primary Objective:

  • Describe real-life survival of CRPC patients who received first-line docetaxel and have disease progression

Secondary Objective:

  • Describe treatment patterns
  • Describe the characteristics and outcomes of patients who received second-line taxane-based treatment compared to others
  • Describe economic and patient-reported outcomes
02

Conditions studied

  • Prostatic Neoplasms

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03

In context

Prostatic Neoplasms

6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.

This study's enrollment of 82 is below the median of 200 across 1,200 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Sanofi is the lead sponsor of 1,547 studies on the registry; 88 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 122 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with metastatic castrate-resistant prostate cancer

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with CRPC progressing during the course of first line docetaxel-based chemotherapy or after at least 3 cycles (equivalent to 225mg/m2) of first line docetaxel-based chemotherapy
  • Patient who have given their written consent

Exclusion criteria

Exclusion criteria:

  • Current participation in a clinical trial for the second-line treatment of prostate cancer
  • Patients having received less than 3 cycles of first line docetaxel-based chemotherapy and discontinued for a reason other than disease progression or toxicity
  • Patients having already started a second line treatment

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
82 participants (actual)

Groups and cohorts

  • CRPC patients
06

What researchers measure

Primary outcomes

  1. Overall survival

    Time frame: At Month 12 or death

Secondary outcomes

  1. Sequence of treatment in second-line, third-line

    Time frame: At Month 6 (+/- 2 months), Month 12 or death

  2. Characteristics and outcomes of patients who receive second-line taxane-based treatment compared to others

    Time frame: At baseline, Month 6 (+/- 2 months), Month 12 or death

  3. Indicators of health care resource utilization

    Time frame: At baseline, Month 6 (+/- 2 months), Month 12 or death

  4. Quality of life

    Time frame: At baseline, Month 6 (+/- 2 months) or Month 12

07

Study locations

5 sites
  • Sanofi-Aventis Administrative Office
    Bridgewater, New Jersey, United States
  • Sanofi-Aventis Administrative Office
    Paris, France
  • Sanofi-Aventis Administrative Office
    Frankfurt, Germany
  • Sanofi-Aventis Administrative Office
    Barcelona, Spain
  • Sanofi-Aventis Administrative Office
    Guildford Surrey, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 14, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01076751
Lead sponsor
Sanofi
First posted
Feb 26, 2010
Start date
Feb 2010
Primary completion
Oct 2010
Completion
Oct 2010
Last update
Feb 14, 2011

Study contacts

Clinical Sciences & Operations
study director · Sanofi
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

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