Modeling Clinical Failure in Prostate Cancer Patients Based on a Two-stage Statistical Model

NCT03979079 | Completed Results

• 1 other identifier: IB2010-PREDYC
• Study Type: observational
• Target: 2,384
• Locations: 1 country
• Sites: 1

Brief Summary

Biomarker series can indicate disease progression and predict clinical endpoints. When a treatment is prescribed depending on the biomarker, confounding by indication might be introduced if the treatment modifies the marker profile and risk of failure. The two-stage model fitted within a Bayesian Markov Chain Monte Carlo framework is particularly flexible to account for such data. Prostate-specific antigens in prostate cancer patients treated with external beam radiation therapy can be monitored. In the presence of rising prostate-specific antigens after external beam radiation therapy, salvage hormone therapy can be prescribed to reduce both the prostate-specific antigens concentration and the risk of clinical failure, an illustration of confounding by indication. The prognostic value of hormone therapy and prostate-specific antigens trajectory on the risk of failure based on a two-stage model within a Bayesian framework to assess the role of the prostate-specific antigens profile on clinical failure while accounting for a secondary treatment prescribed by indication. the aim of this research is to model prostate specific antigens using a hierarchical piecewise linear trajectory with a random changepoint. Residual prostate-specific antigens variability can be expressed as a function of prostate-specific antigens concentration. Covariates in the survival model can include : hormone therapy, baseline characteristics, and individual predictions of the prostate-specific antigens nadir and timing and prostate-specific antigens slopes before and after the nadir as provided by the longitudinal process.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Clinical Failure After Initiation of Radiotherapy

  Clinical failure is defined as any of the following events following initiation of radiotherapy: distant metastases, nodal recurrence, or any palpable or biopsy-detected local recurrence three years after radiation; any local recurrence within three years of RT if the most previous PSA was\>2 ng/ml; and death from prostate cancer.

  within 10 years following initiation of radiotherapy

Secondary Outcomes (1)

• Number of Participants With Initiation of Salvage Therapy After Radiotherapy

  within 10 years following initiation of radiotherapy

Interventions

external beam radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Dataset of 2384 men included in three cohorts: University of Michigan, Ann Arbor, MI, USA (UM); Radiation Therapy Oncology Group (RTOG 9406); and William Beaumont Hospital, Detroit, MI, USA.

You may qualify if:

• clinically localized prostate cancer
• Clinical stage T1 to T4
• Node and metastasis negative
• Treated with external beam radiation therapy (RT).

You may not qualify if:

• Patients with baseline or planned hormonotherapy

Sponsors & Collaborators

• Institut Bergonié: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

INSERM

Bordeaux, France

Location

Related Publications (1)

• Bellera C, Proust-Lima C, Joseph L, Richaud P, Taylor J, Sandler H, Hanley J, Mathoulin-Pelissier S. A two-stage model in a Bayesian framework to estimate a survival endpoint in the presence of confounding by indication. Stat Methods Med Res. 2018 Apr;27(4):1271-1281. doi: 10.1177/0962280216660127. Epub 2016 Sep 1.

  PMID: 27587597 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr Carine Bellera
• Organization: Institut Bergonié

c.bellera@bordeaux.unicancer.fr

33 0 5 56 33 04 95

Study Officials

• Carine Bellera, PhD

  Institut Bergonié

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 7, 2019
• Study Start: January 1, 2010
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 25, 2021
• Results First Posted: December 21, 2020

Record last verified: 2020-12

Locations

FR (1)