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| Name | Class |
|---|---|
| Umeå University | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-metastatic high-risk prostate cancer | ISUP ≥4, T3-4, or regional lymph node positive |
| |
| Low risk prostate cancer | ISUP = 1, PSA <10 µg/L, PSA-density <0,15 µg/l/cm3 |
| |
| Medium risk prostate cancer | ISUP 2-3, PSA 10-20 µg/L |
| |
| Metastatic prostate cancer | PSA > 80 µg/L, clinically manifest metastases |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-risk treatment SOC | Other | radiotherapy (RT) + ADT (3 years) + Abiraterone acetate (2 years), with radical prostatectomy being an option if contraindication for RT exists) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Failure-free survival | From enrollment to 20 years failure-free survival |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarker profiling | Molecular and imagebased characterization of primary tumor. RNA-sequencing, DNA -sequencing, whole genome arrays, analysis of immunohistochemical markers such as Ki67, PSA and AR will be performed as well as MR and PSMA-PET imaging. | From enrollment to 20 years. |
| EORTC QLQ-C15-PAL |
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Inclusion Criteria:
Exclusion Criteria:
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All men who come for biopsy as a part of the investigation for suspected prostate cancer will be invited to participate.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andreas Josefsson, MD, PhD | Contact | +46 907850000 | andreas.josefsson@umu.se | |
| Karin Welen, PhD | Contact | karin.welen@urology.gu.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology, Umeå University Hospital, Region Västerbotten | Recruiting | Umeå | 901 85 | Sweden |
All collected research data apart from identifiable data can be shared pseudonymised.
In most cases results will be presented at group level. However if analysis results at the individual level will be presented baseline information will be presented in the form of intervals to prevent the research subject from being identified. Baseline information could be e.g. age and lab values. Therefore shared data will not be directly traceable to an individual participant.
Starting Jan 2025. Unending.
Proposal that describes planned analyses must be submitted and a data sharing agreement must be signed.
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D000726 | Androgen Antagonists |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
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Tissue from diagnostic prostate biopsies for whole genome RNA and DNA sequencing and tissue evaluations (immunohistochemistry, digital pathology). In selected groups (primarily non-metastatic high risk PC) blood and urine will be sampled for analysis/identification of biomarkers as liquid biopsies
| Active monitoring | Other | Followed with PSA measurements |
|
| Radical prostatectomy | Procedure | Radical prostatectomy |
|
| Radiotherapy | Radiation | Radiotherapy |
|
| Androgen deprivation therapy | Drug | GnRH agonist + abiraterone acetate/enzalutamide and/or docetaxel |
|
Questionnaire on quality of life |
| From enrollment to 20 years. |
| IPSS | Questionnaire on symptoms related to the prostate | From enrollment to 20 years |
| Costs for implementing precision medicine | Evaluation of costs for implementing precision medicine tools including tumor profiling in the clinical workflow. Registration of all time required for handling of patient samples from referral to the clinic until diagnosis decision and cost for preparation/analysis of tissue for molecular characterization. | Before and after implementation of precision medicine workflows |
| Cost effectiveness analysis | Evaluation of health economical costs measured by both crude costs for precision medicine workflow plus specific targeted treatments with or without quality-adjusted life years analysis. Data will be collected from health registries and surveys for quality of life evaluation. | From enrollment to 20 years |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |