Predictive Cancer ModelNCT06092918
Generation and Validation of Predictive Models for Localized Prostate Cancer Treated With External Radiotherapy.
An observational study of Predictive Cancer Model and Localized Prostate Carcinoma, run by Consorci Sanitari de Terrassa.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 95 years, men only
- Conditions the study is for
- Predictive Cancer Model, Localized Prostate Carcinoma
- What is being tested?
- EXTERNAL RADIOTHERAPY
- Type of treatment
- Surgery or procedure
- How many people
- 700 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 1 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Histological confirmation of prostate adenocarcinoma through biopsy. ECOG (Eastern Cooperative Oncology Group) performance status score <2. Signed informed consent form.
Who cannot join
- 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.
About this study
Official title: Generation and Validation of Predictive Models for Localized Prostate Cancer Treated With External Radiotherapy
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.
Read more
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.
Read the detailed description
The general objective of the study is to develop a predictive model for oncological outcomes and bladder and rectal toxicities based on the analysis of patients with localized prostate cancer who have received external radiotherapy, useful for medical decision-making. This objective is divided into three specific objectives:
- Estimate a predictive model for oncological outcomes, such as the probability of Biochemical Recurrence (BR), Disease-Free or Metastasis-Free Time (DFT), Overall Survival (OS), and Cancer-Specific Survival (CSS).
- Estimate a predictive model for bladder and rectal toxicities in patients with localized prostate cancer who have received external radiotherapy.
- Analyze the feasibility and impact of implementing an individualized decision-making model based on this model, and its implementation in oncology committees and in initial (informative) visits in radiation oncology.
- Hypotheses**:
- The developed predictive model will have adequate predictive values.
- Validate and compare the model with other shared decision-making methods in localized prostate cancer in Radiation Oncology Services.
- Professionals and patients will show appropriate satisfaction with the use of this type of model for shared decision-making with the patient in radiation oncology.
- Method**:
This study is divided into phases for its execution:
- Retrospective analysis of 400 patients diagnosed with localized prostate cancer and treated with external radiotherapy between January 2014 and December 2019. Sub-analyses of the population will be conducted to evaluate different oncological outcomes and the produced toxicities, with particular emphasis on distinguishing differences that technological variables may justify.
- Generation and validation of a predictive model for treatment oncological outcomes and bladder and rectal toxicities. The development of the model will follow the TRIPOD guidelines.
- Analysis of the model's implementation in patient decision-making, for which a validated questionnaire will be applied to measure satisfaction with the decision made in patients diagnosed with prostate neoplasia (15). The predictive model will be applied through a pilot study involving 30 patients who will be presented with treatment options based on different outcome scenarios. The questionnaire will be administered after the first visit to radiation oncology to assess the use of predictive models as part of the information provided. This questionnaire will evaluate improvements in the patient's knowledge of prostate cancer, clarity of personal values, decision efficacy, and reduction of uncertainty regarding the decision made.
- Statistical Analysis**:
Phase 1: The annual incidence rate will be calculated using the actuarial method for oncological outcomes, estimating the annual number of cases divided by the sum of the total person-years at risk per 100 treated patients. Rates will be calculated as crude and age-standardized rates, stratified by relevant sociodemographic and clinical characteristics. Rates will be summarized as cumulative incidences over time using a Kaplan-Meier estimator. Individual associations between predictive factors and complication outcomes will be calculated using a bivariate binomial logistic prediction model. The optimal prediction time will be estimated by comparing changes in odds at different time-to-event cutoff points.
Phase 2: The risk prediction model will be constructed using penalized logistic regression techniques to optimize predictive accuracy for the occurrence of oncological outcomes. Model development will be conducted on a subset of training data using k-fold validation, and diagnostic prediction will be calculated using the recalibrated algorithm. The predictive model's performance will be evaluated by calculating the area under the receiver operating characteristic curve and other measures of accuracy for various cutoff points (percentage of patients at maximum risk, maximization of positive and negative predictive value, and F-score).
Phase 3: The predictive model will be applied to 30 new patients. Mean satisfaction with the provided information will be estimated using questionnaire results. Changes in uncertainty before and after receiving information will be assessed using paired-sample t-tests.
- Being tested
- EXTERNAL RADIOTHERAPY
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXTERNAL RADIOTHERAPYRadiation
EXTERNAL RADIOTHERAPY
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical recurrence (BR) as an increase of 2 ng/ml or more above the nadir of PSA
2 ng/ml + nadir
Measured: 5-10 years
Overall Survival (OS)
As the time in months from diagnosis until death or the last follow-up.
Measured: 5-10 years
Secondary outcomes (1)
Grade II toxicity in bladder and rectal
Grade II toxicity in bladder and rectal , according to the Common Terminology Criteria for Adverse Events (CTCAE version 4.03).
Measured: 5-10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Jan 2013
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Predictive Cancer ModelStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de Terrassa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas Feltes, Consorci Sanitari de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092918
- Sponsor's protocol ID
- NOMPROST-1
- Status last verified
- Oct 2023
- First submitted
- 16 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generation and Validation of Predictive Models for Localized Prostate Cancer Treated With External Radiotherapy
- ClinicalTrials.gov ID
- NCT06092918
- Acronym / sponsor ID
- NOMPROST-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Consorci Sanitari de TerrassaUniversity, hospital or other
- Study start
- 1 Jan 2013
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The general objective of the study is to develop a predictive model for oncological outcomes and bladder and rectal toxicities based on the analysis of patients with localized prostate cancer who have received external radiotherapy, useful for medical decision-making. This objective is divided into three specific objectives:
- Estimate a predictive model for oncological outcomes, such as the probability of Biochemical Recurrence (BR), Disease-Free or Metastasis-Free Time (DFT), Overall Survival (OS), and Cancer-Specific Survival (CSS).
- Estimate a predictive model for bladder and rectal toxicities in patients with localized prostate cancer who have received external radiotherapy.
- Analyze the feasibility and impact of implementing an individualized decision-making model based on this model, and its implementation in oncology committees and in initial (informative) visits in radiation oncology.
- Hypotheses**:
- The developed predictive model will have adequate predictive values.
- Validate and compare the model with other shared decision-making methods in localized prostate cancer in Radiation Oncology Services.
- Professionals and patients will show appropriate satisfaction with the use of this type of model for shared decision-making with the patient in radiation oncology.
- Method**:
This study is divided into phases for its execution:
- Retrospective analysis of 400 patients diagnosed with localized prostate cancer and treated with external radiotherapy between January 2014 and December 2019. Sub-analyses of the population will be conducted to evaluate different oncological outcomes and the produced toxicities, with particular emphasis on distinguishing differences that technological variables may justify.
- Generation and validation of a predictive model for treatment oncological outcomes and bladder and rectal toxicities. The development of the model will follow the TRIPOD guidelines.
- Analysis of the model's implementation in patient decision-making, for which a validated questionnaire will be applied to measure satisfaction with the decision made in patients diagnosed with prostate neoplasia (15). The predictive model will be applied through a pilot study involving 30 patients who will be presented with treatment options based on different outcome scenarios. The questionnaire will be administered after the first visit to radiation oncology to assess the use of predictive models as part of the information provided. This questionnaire will evaluate improvements in the patient's knowledge of prostate cancer, clarity of personal values, decision efficacy, and reduction of uncertainty regarding the decision made.
- Statistical Analysis**:
Phase 1: The annual incidence rate will be calculated using the actuarial method for oncological outcomes, estimating the annual number of cases divided by the sum of the total person-years at risk per 100 treated patients. Rates will be calculated as crude and age-standardized rates, stratified by relevant sociodemographic and clinical characteristics. Rates will be summarized as cumulative incidences over time using a Kaplan-Meier estimator. Individual associations between predictive factors and complication outcomes will be calculated using a bivariate binomial logistic prediction model. The optimal prediction time will be estimated by comparing changes in odds at different time-to-event cutoff points.
Phase 2: The risk prediction model will be constructed using penalized logistic regression techniques to optimize predictive accuracy for the occurrence of oncological outcomes. Model development will be conducted on a subset of training data using k-fold validation, and diagnostic prediction will be calculated using the recalibrated algorithm. The predictive model's performance will be evaluated by calculating the area under the receiver operating characteristic curve and other measures of accuracy for various cutoff points (percentage of patients at maximum risk, maximization of positive and negative predictive value, and F-score).
Phase 3: The predictive model will be applied to 30 new patients. Mean satisfaction with the provided information will be estimated using questionnaire results. Changes in uncertainty before and after receiving information will be assessed using paired-sample t-tests.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Histological confirmation of prostate adenocarcinoma through biopsy. ECOG (Eastern Cooperative Oncology Group) performance status score <2. Signed informed consent form.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXTERNAL RADIOTHERAPYEXTERNAL RADIOTHERAPY | Radiation | – |
Primary outcome
Biochemical recurrence (BR) as an increase of 2 ng/ml or more above the nadir of PSA
Time frame: 5-10 years
2 ng/ml + nadir
Overall Survival (OS)
Time frame: 5-10 years
As the time in months from diagnosis until death or the last follow-up.
1 secondary outcome
Grade II toxicity in bladder and rectal
Time frame: 5-10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Predictive Cancer Model and Localized Prostate Carcinoma, run by Consorci Sanitari de Terrassa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical recurrence (BR) as an increase of 2 ng/ml or more above the nadir of PSA (time frame: 5-10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.