The Predictive Value of TMPRSS2-ERG Fusion in High Risk Prostate Cancer Patient

NCT02588404 | Withdrawn

• 1 other identifier: Fusion study
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to evaluate the predictive value of TMPRSS2-ERG gene fusion in patients with prostate cancer treated with radiation and hormonal therapy.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Number of patients with biochemical failure showing presence of TMPRSS2-ERG gene fusion.

  Biopsy samples of patients treated for high risk prostate cancer with radical radiation and hormonal therapy (LHRH) will be tested to evaluate the predictive value of the TMPRSS2-ERG gene fusionThe results between the two groups will be compared to see if either DNA changes are an indicator of LHRH refractoriness

  recruitment over 4 years

Interventions

LHRH therapy DRUG

These patients will be treated with LHRH agonist as standard therapy.

Also known as: Eligard, Lupron, Trelstar, and Zoladex

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The original slides of 65 patients with informed consent will be reviewed. Assuming 50% Gene-fusion carrier rate, patients with and without markers under the investigation will be accrued into this study. The investigators at the treating institutions will submit paraffin-embedded tissue blocks from the original pre-treatment diagnostic prostatic biopsy, which will be reviewed to confirm the Gleason score and to record other histopathologic features, such as the extent of tumor in the biopsies, the number of positive biopsies, and mitotic index. The block must be clearly labeled with the protocol and case number. A tissue microarray (TMA) containing cores representing clinically localized prostate cancers will be constructed from 60 men who underwent radical radiation therapy. Three cores (0.6mm in diameter) will be taken from each representative tissue block to construct the TMA. Detailed clinical, pathological, and TMA data will be maintained on a secure database.

You may qualify if:

• T3a +
• PSA \> 20
• Gleason 8 or higher
• Karnofsky performance status ≥ 70.
• Signed study-specific informed consent

Sponsors & Collaborators

• Sir Mortimer B. Davis - Jewish General Hospital: lead

Biospecimen

Retention: SAMPLES WITH DNA

Areas of prostate tumor will be identified by the pathologist of the study. This will then be excised from the paraffin block using a tissue microarray punch. Two punches will be acquired: one for RNA extraction and one for DNA extraction. RNA and DNA will be extracted using the RecoverAll Nucleic Acid Isolation Kit (Ambion). Standard protocol for the isolation of nucleic acids will be used differing only in the time of protease digestion such that RNA is isolated after a short incubation (30 minutes), while DNA is isolated after a longer incubation (overnight).

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

luprolide acetate gel depot; Leuprolide; Triptorelin Pamoate; Goserelin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 26, 2015
• First Posted: October 27, 2015
• Study Start: December 1, 2015
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: December 10, 2024

Record last verified: 2024-12