Prostate Cancer (Adenocarcinoma)NCT06773858
Genetic Studies of Prostate Cancer Aggressiveness and Prognosis
An observational study of Prostate Cancer (Adenocarcinoma) and Prostate Cancer After a Radical Treatment, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Prostate cancer is the most common form of cancer and the leading cause of cancer-related deaths among men in Sweden. In 2021, over 10,000 men were diagnosed with prostate cancer, and 2,077 died from the disease. Patients diagnosed with early-stage prostate cancer often undergo treatment aimed at curing the disease. Read more about this study
- Who is it for?
- Ages 50 to 69 years, men only
- Conditions the study is for
- Prostate Cancer (Adenocarcinoma), Prostate Cancer After a Radical Treatment
- How many people
- 2,291 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2024to 31 Dec 2024
- 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 50 to 69 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: All men living in the Stockholm area, Sweden, aged 50 to 69 years.
Who may be able to join
- Living in Stockhol, Sweden
- Aged 50 to 69 years.
Who cannot join
- Previous diagnosis of prostate cancer
Trial locations and contacts
1 site in 1 country.
About this study
Prostate cancer is the most common form of cancer and the leading cause of cancer-related deaths among men in Sweden. In 2021, over 10,000 men were diagnosed with prostate cancer, and 2,077 died from the disease. Patients diagnosed with early-stage prostate cancer often undergo treatment aimed at curing the disease. However, since the side effects of active treatment are significant, it is crucial to identify new markers for aggressive forms of prostate cancer to better determine who would benefit most from curative treatment.
The investigators plan to conduct large-scale genetic studies using blood samples from men with prostate cancer. Specifically, the investigators will search for genetic markers associated with the development of more aggressive prostate cancer forms and markers for clinical progression. The clinical relevance of the identified genetic markers will be tested in a large population-based clinical prostate cancer study (the Stockholm-3 study).
The overall goal of this research is to discover new genetic markers for prostate cancer that may lead to more personalized and precise prostate cancer diagnostics.
Read the detailed description
The investigators have the following specific aims:
Aim 1. To perform GWAS and create GRS for aggressive PCa A GWAS for aggressive PCa will be performed in international cohorts comprising 29,896 PCa patients (19,185 with non-aggressive disease and 10,711 with aggressive disease). Using summary statistics from this GWAS in a supervised machine learning framework, The investigators aim to create a GRS predictive of aggressive PCa.
Aim 2. To perform GWAS and create GRS for biochemical recurrence A GWAS for biochemical recurrence will be performed among patients who have undergone radical prostatectomy. Through international collaboration, 5,397 radical-operated patients will be available for assessment, among which biochemical recurrence occurred for 1,071 during follow-up. As in aim 1, supervised machine learning algorithms will be applied to the summary results from the GWAS to create a GRS for biochemical recurrence.
Aim 3. To perform a TWAS for aggressive disease and biochemical recurrence The investigators will perform a multi-tissue TWAS for aggressive disease and biochemical recurrence. Genetic prediction models will be trained using gene expression data measured in 22 tissues from over 3,900 individuals. Through these prediction models, gene expression levels will be imputed in the aggressive (aim 1) and biochemical recurrence (aim 2) study population and explored for association with disease aggressiveness and biochemical recurrence.
Aim 4. To assess the clinical translatability of GRS for aggressive disease and biochemical recurrence Using a large population-based Swedish clinical study of PCa detection, the clinical utility of GRS for aggressive disease and GRS for biochemical recurrence will be explored. In addition, a score based on rare pathogenic variants from 50 DNA repair genes will be assessed. The clinical utility of GRS will be established by comparing the added predictive performance of GRS above established predictive markers, PSA for detection, PSA, Gleason score, and TNM stage for a biochemical recurrence.
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| STHM3 | A cohort comprising 2,295 men diagnosed with prostate cancer from the STHM3 trial population will be analyzed. Clinically significant disease is classified as cases with a Gleason grade ≥7, while aggressive disease is defined as stage T4 or cases with Gleason grade ≥8 in combination with stage T3. Indolent disease is characterized as cases with Gleason grade ≤6. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical recurrence
According to American Urological Association guidelines, biochemical recurrence will be defined as a rise in PSA level of at least 0.2 ng/mL after surgery followed by a subsequent confirmatory PSA value of at least 0.2 ng/mL.
Measured: From date of surgery date until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start1 Jan 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Adenocarcinoma)Studies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 2,291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fredrik Wiklund, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06773858
- Sponsor's protocol ID
- 2023-02626
- Other IDs
- 2023
- Status last verified
- Jan 2025
- First submitted
- 2 Jan 2025
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only summary statistics from our study will be shared with other research groups to enable meta-analysis across groups.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Studies of Prostate Cancer Aggressiveness and Prognosis
- ClinicalTrials.gov ID
- NCT06773858
- Acronym / sponsor ID
- 2023-02626
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,291 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 14 Jan 2025 (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.
Prostate cancer is the most common form of cancer and the leading cause of cancer-related deaths among men in Sweden. In 2021, over 10,000 men were diagnosed with prostate cancer, and 2,077 died from the disease. Patients diagnosed with early-stage prostate cancer often undergo treatment aimed at curing the disease. However, since the side effects of active treatment are significant, it is crucial to identify new markers for aggressive forms of prostate cancer to better determine who would benefit most from curative treatment.
The investigators plan to conduct large-scale genetic studies using blood samples from men with prostate cancer. Specifically, the investigators will search for genetic markers associated with the development of more aggressive prostate cancer forms and markers for clinical progression. The clinical relevance of the identified genetic markers will be tested in a large population-based clinical prostate cancer study (the Stockholm-3 study).
The overall goal of this research is to discover new genetic markers for prostate cancer that may lead to more personalized and precise prostate cancer diagnostics.
Detailed description
The investigators have the following specific aims:
Aim 1. To perform GWAS and create GRS for aggressive PCa A GWAS for aggressive PCa will be performed in international cohorts comprising 29,896 PCa patients (19,185 with non-aggressive disease and 10,711 with aggressive disease). Using summary statistics from this GWAS in a supervised machine learning framework, The investigators aim to create a GRS predictive of aggressive PCa.
Aim 2. To perform GWAS and create GRS for biochemical recurrence A GWAS for biochemical recurrence will be performed among patients who have undergone radical prostatectomy. Through international collaboration, 5,397 radical-operated patients will be available for assessment, among which biochemical recurrence occurred for 1,071 during follow-up. As in aim 1, supervised machine learning algorithms will be applied to the summary results from the GWAS to create a GRS for biochemical recurrence.
Aim 3. To perform a TWAS for aggressive disease and biochemical recurrence The investigators will perform a multi-tissue TWAS for aggressive disease and biochemical recurrence. Genetic prediction models will be trained using gene expression data measured in 22 tissues from over 3,900 individuals. Through these prediction models, gene expression levels will be imputed in the aggressive (aim 1) and biochemical recurrence (aim 2) study population and explored for association with disease aggressiveness and biochemical recurrence.
Aim 4. To assess the clinical translatability of GRS for aggressive disease and biochemical recurrence Using a large population-based Swedish clinical study of PCa detection, the clinical utility of GRS for aggressive disease and GRS for biochemical recurrence will be explored. In addition, a score based on rare pathogenic variants from 50 DNA repair genes will be assessed. The clinical utility of GRS will be established by comparing the added predictive performance of GRS above established predictive markers, PSA for detection, PSA, Gleason score, and TNM stage for a biochemical recurrence.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STHM3 | – | –A cohort comprising 2,295 men diagnosed with prostate cancer from the STHM3 trial population will be analyzed. Clinically significant disease is classified as cases with a Gleason grade ≥7, while aggressive disease is defined as stage T4 or cases with Gleason grade ≥8 in combination with stage T3. Indolent disease is characterized as cases with Gleason grade ≤6. |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All men living in the Stockholm area, Sweden, aged 50 to 69 years.
Key inclusion criteria (2 listed)
- Living in Stockhol, Sweden
- Aged 50 to 69 years.
Key exclusion criteria (1 listed)
- Previous diagnosis of prostate cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Biochemical recurrence
Time frame: From date of surgery date until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 11 months
According to American Urological Association guidelines, biochemical recurrence will be defined as a rise in PSA level of at least 0.2 ng/mL after surgery followed by a subsequent confirmatory PSA value of at least 0.2 ng/mL.
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 16 Jan 2025.
- Individual participant dataSharing planned: No. Only summary statistics from our study will be shared with other research groups to enable meta-analysis across groups.
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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.
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 (Adenocarcinoma) and Prostate Cancer After a Radical Treatment, run by Karolinska Institutet 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: finished, as of the sponsor's last update on 16 Jan 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?
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 (time frame: From date of surgery date until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 11 months). 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 16 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.