Genetic Studies of Prostate Cancer Aggressiveness and Prognosis

NCT06773858 | Completed

• 1 other identifier: 2023-02626
• Study Type: observational
• Target: 2,291
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Prostate Cancer (Adenocarcinoma); Prostate Cancer After a Radical Treatment

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Study Arms (1)

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.

Eligibility Criteria

• Age: 50 Years - 69 Years
• Gender Eligibility Details: Only men can develop prostate cancer.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All men living in the Stockholm area, Sweden, aged 50 to 69 years.

You may qualify if:

• Living in Stockhol, Sweden
• Aged 50 to 69 years.

You may not qualify if:

• Previous diagnosis of prostate cancer

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet

Stockholm, Stockholm County, 171 77, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples.

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 14, 2025
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)