Micro RNAs to Predict Response to Androgen Deprivation Therapy

NCT02366494 | Completed DMC FDA Drug

• 1 other identifier: 23842
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Identify exosomal micro RNA that predict responses to ADT

Conditions

Prostate Cancer

Keywords

prostate cancer; treatment response; androgen deprivation therapy

Outcome Measures

Primary Outcomes (1)

• Identify five most prevalent exosomal microRNAs that predict response to androgen deprivation therapy based treatment.

  Two hundred to 300 microRNAs will be identified by RNA sequencing. This outcome measure will report the read count per million of the top-five most prevalent microRNAs that correlate with responses.

  Up to two years

Study Arms (2)

Androgen blockade

Androgen DeprivationTherapy or Complete Androgen Blockade

Drug: Bicalutamide; Drug: Leuprolide; Drug: Goserelin; Drug: Triptorelin

Hormonal Therapy and Chemotherapy

Hormonal therapy, novel oral hormonal therapy (abiraterone/apalutamide/enzalutamide) and chemotherapy (docetaxel)

Drug: Bicalutamide; Drug: Leuprolide; Drug: Goserelin; Drug: Triptorelin; Drug: Docetaxel; Drug: Abiraterone; Drug: Apalutamide; Drug: Enzalutamide

Interventions

Bicalutamide DRUG

ANDROGEN BLOCKADE

Also known as: Casodex

Androgen blockade; Hormonal Therapy and Chemotherapy

Leuprolide DRUG

ANDROGEN BLOCKADE

Also known as: Lupron

Androgen blockade; Hormonal Therapy and Chemotherapy

Goserelin DRUG

ANDROGEN BLOCKADE

Also known as: Zoladex

Androgen blockade; Hormonal Therapy and Chemotherapy

Triptorelin DRUG

ANDROGEN BLOCKADE

Also known as: Trelstar

Androgen blockade; Hormonal Therapy and Chemotherapy

Docetaxel DRUG

Chemo hormonal therapy

Also known as: Taxotere

Hormonal Therapy and Chemotherapy

Abiraterone DRUG

Chemo hormonal therapy

Also known as: Zytiga

Hormonal Therapy and Chemotherapy

Apalutamide DRUG

Nonsteroidal antiandrogen medication

Also known as: Erleada

Hormonal Therapy and Chemotherapy

Enzalutamide DRUG

Nonsteroidal antiandrogen medication

Also known as: Xtandi

Hormonal Therapy and Chemotherapy

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Men with systemic disease ( with biochemical relpase or metastaic disease)

You may qualify if:

• Histologically proven prostate cancer.
• Testosterone level \>30ng/ml and at least 6 months since last dose of hormonal therapy.
• History/physical examination including a detailed description of the stage of prostate cancer within 8 weeks prior to registration.
• CT scan of abdomen and pelvis with IV contrast and bone scan should be performed within 8 weeks prior to registration.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
• Age ≥ 18.
• Patients must provide study-specific informed consent prior to study entry for this project and mandatory blood specimen for banking for future studies (future studies may include genetic testing).

You may not qualify if:

• Received hormonal therapy less than 6 months prior to registration.
• History of active secondary malignancy.
• Decline hormone therapy for prostate cancer.
• Current or previous treatment with 5-alpha reductase inhibitors within 6 months prior to enrollment.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (3)

• Scher HI, Halabi S, Tannock I, Morris M, Sternberg CN, Carducci MA, Eisenberger MA, Higano C, Bubley GJ, Dreicer R, Petrylak D, Kantoff P, Basch E, Kelly WK, Figg WD, Small EJ, Beer TM, Wilding G, Martin A, Hussain M; Prostate Cancer Clinical Trials Working Group. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol. 2008 Mar 1;26(7):1148-59. doi: 10.1200/JCO.2007.12.4487.

  PMID: 18309951 BACKGROUND

• Huggins C, Hodges CV. Studies on prostatic cancer. I. The effect of castration, of estrogen and androgen injection on serum phosphatases in metastatic carcinoma of the prostate. CA Cancer J Clin. 1972 Jul-Aug;22(4):232-40. doi: 10.3322/canjclin.22.4.232. No abstract available.

  PMID: 4625049 BACKGROUND

• Taplin ME, Xie W, Bubley GJ, Ernstoff MS, Walsh W, Morganstern DE, Regan MM. Docetaxel, estramustine, and 15-month androgen deprivation for men with prostate-specific antigen progression after definitive local therapy for prostate cancer. J Clin Oncol. 2006 Dec 1;24(34):5408-13. doi: 10.1200/JCO.2006.06.6589.

  PMID: 17135641 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood collection at pre treatment (at enrollment), 3 months post treatment, and at the time of disease progression (or at 2 years post treatment).

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

bicalutamide; Leuprolide; Goserelin; Triptorelin Pamoate; Docetaxel; abiraterone; Abiraterone Acetate; apalutamide; enzalutamide

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; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Deepak Kilari, MD

  The Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 12, 2015
• First Posted: February 19, 2015
• Study Start: April 29, 2015
• Primary Completion: May 11, 2021
• Study Completion: May 11, 2021
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)