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

NCT06092918 | Completed DMC

• 1 other identifier: NOMPROST-1
• Study Type: observational
• Target: 700
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Predictive Cancer Model; Localized Prostate Carcinoma

Outcome Measures

Primary Outcomes (2)

• Biochemical recurrence (BR) as an increase of 2 ng/ml or more above the nadir of PSA

  2 ng/ml + nadir

  5-10 years

• Overall Survival (OS)

  As the time in months from diagnosis until death or the last follow-up.

  5-10 years

Secondary Outcomes (1)

• Grade II toxicity in bladder and rectal

  5-10 years

Interventions

EXTERNAL RADIOTHERAPY RADIATION

EXTERNAL RADIOTHERAPY

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with prostate cancer through prostate biopsy and presented in the Oncology Committees of some of the hospitals in the healthcare region of Vallès Occidental, which may include Parc Tauli Hospital (Sabadell), Terrassa Hospital (Terrassa), General Hospital of Catalonia (Sant Cugat del Vallès), and San Joan de Deu Hospital (Manresa). These patients have been treated with external radiotherapy in the Radiation Oncology Department of Terrassa Hospital or General Hospital of Catalonia and are currently under active surveillance with in-person semi-annual visits and PSA monitoring.

You may qualify if:

• Histological confirmation of prostate adenocarcinoma through biopsy. ECOG (Eastern Cooperative Oncology Group) performance status score \<2. Signed informed consent form.

You may not qualify if:

• Affected lymph nodes or confirmed metastatic disease (bone or lymph node) in prostate cancer based on imaging studies (CT scan, bone scan, MRI).
• Anticoagulant therapy, individual evaluation of antiplatelet therapy. Prior pelvic radiotherapy. Prior surgery for prostate cancer. Personal history of Crohn's disease or ulcerative colitis.

Sponsors & Collaborators

• Consorci Sanitari de Terrassa: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 23, 2023
• Study Start: January 1, 2013
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share