The first patient-reported outcomes from the Utrecht Prostate Cohort (UPC): the first platform facilitating ‘trials within cohorts’ (TwiCs) for the evaluation of interventions for prostate cancer - Scorecard - MDSpire
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The first patient-reported outcomes from the Utrecht Prostate Cohort (UPC): the first platform facilitating ‘trials within cohorts’ (TwiCs) for the evaluation of interventions for prostate cancer
Clinical Scorecard: Initial Patient-Reported Outcomes from the Utrecht Prostate Cohort (UPC): A Novel Platform for Conducting 'Trials within Cohorts' (TwiCs) to Assess Prostate Cancer Interventions
At a Glance
Category
Detail
Condition
Non-metastatic, histologically proven prostate cancer
Key Mechanisms
Use of Trials within Cohorts (TwiCs) design to evaluate multiple prostate cancer interventions simultaneously within a prospective observational cohort
Target Population
Men diagnosed with non-metastatic prostate cancer eligible for standard or experimental treatments
Care Setting
Urology clinics and radiotherapy facilities within the Netherlands
Key Highlights
UPC cohort enables real-life data infrastructure for short- and long-term clinical and patient-reported outcomes in prostate cancer treatment.
TwiCs design allows randomized evaluation of multiple experimental interventions compared to standard care within the same cohort.
Staged-informed consent permits broad consent for future random allocation to experimental treatments, improving trial participation and reducing bias.
Guideline-Based Recommendations
Diagnosis
Histological confirmation of prostate cancer is required for inclusion.
Comprehensive staging including PSA level, TNM classification, imaging (PI-RADS, PSMA-PET CT, bone scintigraphy) is recommended.
Management
Standard curative treatments include EBRT, brachytherapy, and robot-assisted radical prostatectomy.
Active surveillance is an option for selected low- and intermediate-risk patients.
Experimental treatments such as MR-guided radiotherapy, HIFU, and irreversible electroporation are under evaluation within the cohort.
Monitoring & Follow-up
Regular PSA measurements to assess recurrence and progression-free survival.
Use of validated patient-reported outcome measures at baseline and multiple follow-up time points (1, 3, 6, 9, 12, 18, 24 months).
Assessment of acute and chronic toxicity using CTCAE v5 and surgical complications via Clavien Dindo classification.
Risks
Radical treatments carry risks of genitourinary and gastrointestinal adverse events and erectile dysfunction.
Potential for patient disappointment or dropout in randomized trials due to allocation to control arm mitigated by TwiCs design.
Patient & Prescribing Data
Men with non-metastatic prostate cancer enrolled in the UPC cohort across multiple Dutch centers.
Real-world data collection facilitates evaluation of treatment effectiveness, safety, and patient-reported quality of life outcomes across standard and experimental interventions.
Clinical Best Practices
Implement staged-informed consent to enable efficient enrollment and randomization within the TwiCs design.
Collect comprehensive clinical, pathological, imaging, and patient-reported data prospectively to support robust outcome assessment.
Use a cloud-based database and standardized toxicity and complication grading systems to ensure data quality and comparability.
Inform all patients about study results after completion regardless of individual participation in specific interventions.
Recent research at Roswell Park Comprehensive Cancer Center led by Anurag Singh, MD, Director of Radiation Research, has shown that for patients with peripherally located lung cancer, one treatment of stereotactic body radiation therapy (SBRT) is equally effective as longer courses radiation therapy.
This twice-monthly newsletter highlights recently published research where Dana-Farber faculty are listed as first or senior authors. The information is pulled from PubMed and this issue notes papers published from February 16 - 28.
