Prostate CancerSPRINTR-REALNCT06687421
Implementation of Precision Medicine in High-risk Prostate Cancer
An observational study of Prostate Cancer, run by Andreas Josefsson at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- High-risk treatment SOC, Active monitoring and Radical prostatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 5,500 participants
- Where
- 1 siteSweden
- Study dates
- 10 Jun 2024to Dec 2054
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: All men who come for biopsy as a part of the investigation for suspected prostate cancer will be invited to participate.
Who may be able to join
- Men investigated for suspected prostate cancer
- Signed consent form
Who cannot join
- Difficulties understanding information about the study due to linguistic, cognitive or other reason
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Karin Welen, PhD contact
Sweden1 site, 1 recruiting
- Recruiting
Urology, Umeå University Hospital, Region Västerbotten
Umeå, 901 85
Andreas Josefsson, MD, PhD, +46 907850000, andreas.josefsson@umu.se
About this study
Official title: Swedish Prostate Cancer Initiative for Novel Treatment Regimens - Real, Implementation of Precision Medicine in High-risk Prostate Cancer
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.
Read the 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
- Conditions
- Prostate Cancer
- Being tested
- High-risk treatment SOC, Active monitoring, Radical prostatectomy, Radiotherapy, Androgen deprivation therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-risk treatment SOCOther
radiotherapy (RT) + ADT (3 years) + Abiraterone acetate (2 years), with radical prostatectomy being an option if contraindication for RT exists)
Active monitoringOther
Followed with PSA measurements
Radical prostatectomyProcedure or surgery
Radical prostatectomy
RadiotherapyRadiation
Radiotherapy
Androgen deprivation therapyDrug
GnRH agonist + abiraterone acetate/enzalutamide and/or docetaxel
| Study group | Role | What they receive |
|---|---|---|
| Non-metastatic high-risk prostate cancer | ISUP ≥4, T3-4, or regional lymph node positive Receives: Other: High-risk treatment SOC | |
| Low risk prostate cancer | ISUP = 1, PSA <10 µg/L, PSA-density <0,15 µg/l/cm3 Receives: Other: Active monitoring | |
| Medium risk prostate cancer | ISUP 2-3, PSA 10-20 µg/L Receives: Procedure: Radical prostatectomy; Radiation: Radiotherapy | |
| Metastatic prostate cancer | PSA > 80 µg/L, clinically manifest metastases Receives: Drug: Androgen deprivation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure-free survival
Measured: From enrollment to 20 years failure-free survival
Secondary outcomes (5)
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.
Measured: From enrollment to 20 years.
EORTC QLQ-C15-PAL
Questionnaire on quality of life
Measured: From enrollment to 20 years.
IPSS
Questionnaire on symptoms related to the prostate
Measured: 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.
Measured: 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.
Measured: From enrollment to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start10 Jun 2024
- Primary completionDec 2054 (estimated)
- Study completionDec 2054 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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
- 5,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andreas Josefsson
- Sponsor type
- Other government
- Collaborators
- Umeå University
- Responsible party
- Sponsor-investigator, Andreas Josefsson, Region Västerbotten
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687421
- Sponsor's protocol ID
- SPRINTR-REAL
- Acronym
- SPRINTR-REAL
- Status last verified
- Aug 2025
- First submitted
- 16 Oct 2024
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swedish Prostate Cancer Initiative for Novel Treatment Regimens - Real, Implementation of Precision Medicine in High-risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT06687421
- Acronym / sponsor ID
- SPRINTR-REAL / SPRINTR-REAL
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,500 participants (estimated)
- Lead sponsor
- Andreas JosefssonOther government
- Collaborators
- Umeå University
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- Dec 2054 (estimated)
- Study completion
- Dec 2054 (estimated)
- First posted
- 13 Nov 2024 (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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-metastatic high-risk prostate cancer | – | Other: High-risk treatment SOCISUP ≥4, T3-4, or regional lymph node positive |
| Low risk prostate cancer | – | Other: Active monitoringISUP = 1, PSA <10 µg/L, PSA-density <0,15 µg/l/cm3 |
| Medium risk prostate cancer | – | Procedure: Radical prostatectomy, Radiation: RadiotherapyISUP 2-3, PSA 10-20 µg/L |
| Metastatic prostate cancer | – | Drug: Androgen deprivation therapyPSA > 80 µg/L, clinically manifest metastases |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All men who come for biopsy as a part of the investigation for suspected prostate cancer will be invited to participate.
Key inclusion criteria (2 listed)
- Men investigated for suspected prostate cancer
- Signed consent form
Key exclusion criteria (1 listed)
- Difficulties understanding information about the study due to linguistic, cognitive or other reason
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 |
|---|---|---|
| High-risk treatment SOCradiotherapy (RT) + ADT (3 years) + Abiraterone acetate (2 years), with radical prostatectomy being an option if contraindication for RT exists) | Other | Non-metastatic high-risk prostate cancer |
| Active monitoringFollowed with PSA measurements | Other | Low risk prostate cancer |
| Radical prostatectomyRadical prostatectomy | Procedure or surgery | Medium risk prostate cancer |
| RadiotherapyRadiotherapy | Radiation | Medium risk prostate cancer |
| Androgen deprivation therapyGnRH agonist + abiraterone acetate/enzalutamide and/or docetaxel | Drug | Metastatic prostate cancer |
Primary outcome
Failure-free survival
Time frame: From enrollment to 20 years failure-free survival
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Karin Welen, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Andreas Josefsson at 1 site in Sweden.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andreas Josefsson, MD, PhD (+46 907850000, andreas.josefsson@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure-free survival (time frame: From enrollment to 20 years failure-free survival). 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 3 Sep 2025.