Implementation of Precision Medicine in High-risk Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High-risk treatment SOC, Active monitoring, Radical prostatectomy, Radiotherapy.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Swedish Prostate Cancer Initiative for Novel Treatment Regimens - Real, Implementation of Precision Medicine in High-risk Prostate Cancer
Overview
This project's objective is to initiate a prospective non-interventional clinical study to perform full molecular characterization and subtyping of the primary tumor prostate cancer patients. It will identify, compare, and select biomarkers for treatment response in high-risk/metastatic prostate cancer.
Detailed description
This prospective study includes molecular characterization of the primary tumor, biobanking of urine and blood, questionnaires, collection of health economic parameters, cross-checking of registries to link both other diagnoses and drug use to the different biomarkers and socio-economic parameters.
Clinical variables including imaging and routine pathology and the outcome of the molecular diagnostic analysis should, in addition to the basic scientific purpose, also be able to identify men who may be eligible for other studies, both pharmaceutical company-funded and investigator-initiated studies.
One aim is also to develop the national medical information system already in place for prostate cancer (individual patient record) with molecular profiling and other variables for health estimation, health economics and also enable retrieval from more registries.
This study will form the basis for the start of a nationwide study with the aim to prioritize biomarkers for the development of treatment predictive algorithms
Interventions
- Other High-risk treatment SOC
radiotherapy (RT) + ADT (3 years) + Abiraterone acetate (2 years), with radical prostatectomy being an option if contraindication for RT exists) - Other Active monitoring
Followed with PSA measurements - Procedure Radical prostatectomy
Radical prostatectomy - Radiation Radiotherapy
Radiotherapy - Drug Androgen deprivation therapy
GnRH agonist + abiraterone acetate/enzalutamide and/or docetaxel
Primary outcome measures
- Failure-free survival [Time frame: From enrollment to 20 years failure-free survival]
Secondary outcome measures (5)
- Biomarker profiling [Time frame: From enrollment to 20 years.]
- EORTC QLQ-C15-PAL [Time frame: From enrollment to 20 years.]
- IPSS [Time frame: From enrollment to 20 years]
- Costs for implementing precision medicine [Time frame: Before and after implementation of precision medicine workflows]
- Cost effectiveness analysis [Time frame: From enrollment to 20 years]
Eligibility criteria
Inclusion criteria
- Men investigated for suspected prostate cancer
- Signed consent form
Exclusion criteria
- Difficulties understanding information about the study due to linguistic, cognitive or other reason
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Sweden · 1 center
- Urology, Umeå University Hospital, Region Västerbotten — Umeå
Identifiers
NCT: NCT06687421 · SPRINTR-REAL