Race-related Alternative Splicing: Novel Targets in Prostate Cancer

Completed

• Conditions: Prostate Cancer
• Interventions: Other: No interventions - retrospective data collection

• Registration Number: NCT03424213
• Lead Sponsor: Duke University

Brief Summary

Data from evaluating prostate cancer (PCa) biopsy tissue from AA and white patients has led to the discovery of alternative splicing as a novel molecular mechanism underlying more aggressive PCa in AA men. Coded archival radical prostatectomy tissue specimens and annotated clinical data, questionnaire data, and ancestral genotyping data will be obtained from the racially diverse and federally funded North Carolina-Louisiana PCa Project (NC-LA PCaP). We will use 33 tissue specimens from each of the following 6 groups (n=198 total): white low aggressive, white intermediate aggressive, white high aggressive, AA low aggressive, AA intermediate aggressive and AA high aggressive. The aforementioned tissues will first be screened for tumor content and Gleason grade by a genitourinary pathologist. To identify race-related splice variants, RNA will be isolated for targeted sequencing of prioritized race-related alternatively spliced genes using the NimbleGen SeqCap Target Enrichment, SeqCap RNA System to capture regions of interest and the Illumina HiSeq sequencing platform to sequence these regions at a depth and coverage sufficient to accurately call alternative splicing events.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-30
• Study First Submitted: 2018-01-31
• Study First Submitted QC: 2018-01-31
• Study First Posted: 2018-02-06
• Primary Completion: 2021-07-14
• Study Completion: 2021-07-14
• Status Verified: 2022-01
• Last Update Submitted: 2022-02-01
• Last Update Posted: 2022-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 169

Inclusion Criteria

1. Confirmed diagnosis of prostate cancer.
2. Self-reported race of AA or white.
3. Availability of five unstained slides per radical prostatectomy specimen and an associated Hematoxylin and Eosin stained slide for each radical prostatectomy specimen from NC-LA PCaP.
4. Classification of prostate cancer of low, intermediate or high aggressiveness, as defined by NC-LA PCaP.

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Exclusion Criteria

1. Obtained radical prostatectomy tissue is inadequate for RNA analysis and/or is not positive for adenocarcinoma of the prostate of low, intermediate or high aggressiveness.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AA high aggressive	No interventions - retrospective data collection	high aggressive = Gleason score ≥ 8 or PSA \> 20 ng/ml or Gleason score = 7 and stage cT3-cT4
AA intermediate aggressive	No interventions - retrospective data collection	intermediate aggressive = all other cases
white low aggressive	No interventions - retrospective data collection	low aggressive = Gleason score \< 7 and stage cT1-cT2 and PSA \< 10 ng/ml
white high aggressive	No interventions - retrospective data collection	high aggressive = Gleason score ≥ 8 or PSA \> 20 ng/ml or Gleason score = 7 and stage cT3-cT4
white intermediate aggressive	No interventions - retrospective data collection	intermediate aggressive = all other cases
AA low aggressive	No interventions - retrospective data collection	low aggressive = Gleason score \< 7 and stage cT1-cT2 and PSA \< 10 ng/ml

Primary Outcome Measures

Name	Time	Method
Frequency of candidate race-related splice variants in localized prostate cancer of varying degrees of aggressiveness	at the time of analysis

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States