NCT06092918

Generation and Validation of Predictive Models for Localized Prostate Cancer Treated With External Radiotherapy.

Completed Last updated 23 October 2023

What this trial tests

trial testing EXTERNAL RADIOTHERAPY in Predictive Cancer Model in 700 participants. Completed in 1 January 2023.

Timeline

1 January 2013

Primary endpoint
1 January 2023

1 January 2023

Quick facts

Lead sponsor	Consorci Sanitari de Terrassa
Status	Completed
Study type	OBSERVATIONAL
Enrollment	700
Start date	1 January 2013
Primary completion	1 January 2023
Estimated completion	1 January 2023

Drugs / interventions tested

• EXTERNAL RADIOTHERAPY

Conditions studied

• Predictive Cancer Model — all drugs for Predictive Cancer Model →
• Localized Prostate Carcinoma — all drugs for Localized Prostate Carcinoma →

Sponsor

Consorci Sanitari de Terrassa — full company profile →

Who can join

Adults 18 to 95, male only, with Predictive Cancer Model or Localized Prostate Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The generation of predictive models in radiotherapy has seen a significant increase. In 2017, Raymond published the largest systematic review of predictive prognostic models for biochemical relapse (BR), metastasis-free survival, and overall survival in patients with localized prostate cancer treated with radiotherapy (14), attempting to identify whether they were adequately developed and validated.

He found 72 unique predictive models for external radiotherapy: 22 corresponding to BR risk, 20 corresponding to Cancer-Specific Survival, 10 corresponding to Overall Survival, and 20 for Disease/Metastasis-Free Survival detection. In his analysis, he highlighted a significant variation in the quality of these predictive models, understanding that they were developed prior to the existence of TRIPOD guidelines.

In this regard, he pointed out that 54% of these models did not report their accuracy, and 61% of the models lacked validation (either internal or external). He also noted that they had limited follow-up (only 65% had follow-up beyond 5 years), that the treatment doses in these models were lower than current standards, and that the radiation techniques were different from current practices. Although in his final assessment, Raymond maintains that predictive models provide more certainty in predicting oncological outcomes than professional assessments, he considers it vital to validate these models for each population that wants to use them (the vast majority of these models are based on U.S. populations) or, even better, to generate predictive models specific to the local population while adhering to the TRIPOD guidelines.

Probably due to the lack of validation in our patients for existing predictive models and/or the absence of predictive models originating from our population, in our routine clinical practice (Multidisciplinary Oncology Committees), phisycians do not apply any predictive models to patients diagnosed with localized prostate cancer.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Prognostic Factors Associated with Biochemical Relapse After Radiotherapy in Localized Prostate Cancer: A Retrospective Cohort Study.
   Feltes Benitez N, Couñago F, Paredes Rubio S, Galdeano-Rubio M, et al · · 2025 · PMID 41007748 · DOI 10.3390/biomedicines13092185