Gene Expression in Patients With Metastatic Prostate Cancer Receiving CYP-17 Inhibition Therapy

NCT01953640 | Active Not Recruiting DMC

• 7 other identifiers: MC1351R01CA130908R01CA212097R01CA203849W81XWH-15-1-0634NCI-2013-0162813-001296
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 3

Brief Summary

This research trial studies gene expression in patients with prostate cancer that has spread to other places in the body receiving cytochrome P450 17 alpha hydroxylase/17,20 lyase (CYP-17) inhibition therapy. Studying samples of tissue, blood, and urine in the laboratory from patients receiving CYP-17 inhibition therapy may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer. It may also help doctors understand how well patients respond to treatment.

Conditions

Hormone-Resistant Prostate Cancer; Metastatic Prostate Carcinoma; Prostate Adenocarcinoma; Recurrent Prostate Carcinoma

Outcome Measures

Primary Outcomes (1)

• Occurrence of PFS as defined by Prostate Cancer Working Group 2 criteria

  Up to 14 weeks

Secondary Outcomes (2)

• Overall survival after receiving abiraterone acetate

  Up to 5 years

• PFS after receiving abiraterone acetate

  Up to 5 years

Other Outcomes (3)

• Circulating tumor cells

  Up to 14 weeks

• Novel somatic changes within gene and gene pathway that form the genomic signature

  Baseline to up to 14 weeks

• Tumor "signatures" by using immortalized xenograft models

  Up to 14 weeks

Study Arms (1)

Ancillary-correlative (gene expression with CYP-17 inhibition)

Laboratory Biomarker Analysis: Tissue, blood, and urine samples are collected at baseline and after 12-14 weeks of treatment and assessed for circulating tumor cells, genome-wide SNP, and exome sequencing. Subjects will also receive a Quality-of-Life Assessment.

Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment

Interventions

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Ancillary-correlative (gene expression with CYP-17 inhibition)

Laboratory Biomarker Analysis OTHER

Correlative studies

Ancillary-correlative (gene expression with CYP-17 inhibition)

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

Males age \> 18 years with adenocarcinoma of the prostate

You may qualify if:

• Histological diagnosis of adenocarcinoma of the prostate or documented history in medical records of having received treatment for prostate cancer diagnosis
• Metastatic disease on chest, abdominal, or pelvic computed tomography (CT) and/or bone scan amenable to biopsy
• Hemoglobin (HgB) \> 9.0 gm
• Absolute neutrophil count (ANC) \>= 1500 cells/L
• Platelets \>= 100,000 u/L
• Creatinine =\< 1.5 x upper limit of normal (ULN)
• Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase (AST)) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase (ALT)) =\< 1.5 x ULN
• Castrate serum testosterone level (\< 50 ng/dL -or- \< 1.7 nmol/L)
• Progression while on or after androgen deprivation therapy defined as:
• Progressive measurable disease: at least a 20% increase in the sum of the longest diameters of measurable lesions over the smallest sum observed or the appearance of one or more new lesions as assessed by imaging during hormone ablation treatment; measurable lesions are nodal or visceral soft-tissue lesions with nodal lesions \>= 20 mm in diameter or visceral/soft-tissue lesions \>= 10 mm in diameter OR
• Bone scan progression: appearance of 2 or more new lesions on bone scan during hormone ablation treatment OR
• Increasing serum prostate-specific antigen (PSA) level: two consecutive increases in PSA levels documented over a previous reference value obtained at least one week apart are required; if the third PSA value is less than the second, an additional fourth test to confirm a rising PSA is acceptable; a minimum starting value of 2.0 ng/mL is required for study enrollment
• Note: androgen deprivation therapy may have included either medical or surgical castration
• \>= 14 days has passed since completing radiotherapy (exception for radiotherapy: \>= 7 days since completing a single fraction of =\< 800 centigray (cGy) to a restricted field or limited-field radiotherapy to non-marrow bearing area such as an extremity or orbit) at the time of registration
• Patients who may have received systemic chemotherapy or any novel therapeutic CYP-17 inhibitor and/or novel androgen receptor (AR) inhibitor agents previously for prostate cancer should have received the last dose of the previously administered systemic therapy \>= 12 months from the date of registration

You may not qualify if:

• Use of any of these therapies =\< 12 months prior to registration:
• Use of ketoconazole with steroids =\< 12 months prior to registration for CRPC stage
• Receiving any intermittent hormonal treatment GnRH analogues and has not yet achieved sub-castrate levels of testosterone (\< 50 ng/dl or \< 1.7 mmol/L)
• History of or current documented brain metastasis or carcinomatous meningitis, treated or untreated; Note: brain imaging for asymptomatic patients is not required
• Current symptomatic cord compression requiring surgery or radiation therapy
• Note: once successfully treated and there has been no progression, patients are eligible for the study
• Active second malignancy (except non-melanomatous skin or superficial bladder cancer) defined as requiring anticancer therapy or at high risk of recurrence during the study
• Uncontrolled medical conditions such as heart failure, myocardial infarction, uncontrolled hypertension, disseminated on-going coagulopathy, stroke or treatment of a major active infection =\< 3 months of registration, as well as any significant concurrent medical illness that in the opinion of the Investigator would preclude protocol therapy
• Planned concomitant participation in another clinical trial of an experimental agent, vaccine, or device
• Note: concomitant participation in observational studies is acceptable
• Patients with a global or severe deterioration of health status such that it requires discontinuation of standard of care treatments for CRPC stage without evidence of disease progression =\< 12 weeks prior to registration

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• Qin S, Liu D, Kohli M, Wang L, Vedell PT, Hillman DW, Niu N, Yu J, Weinshilboum RM, Wang L. TSPYL Family Regulates CYP17A1 and CYP3A4 Expression: Potential Mechanism Contributing to Abiraterone Response in Metastatic Castration-Resistant Prostate Cancer. Clin Pharmacol Ther. 2018 Jul;104(1):201-210. doi: 10.1002/cpt.907. Epub 2017 Nov 22.

  PMID: 29027195 DERIVED

• Hart SN, Ellingson MS, Schahl K, Vedell PT, Carlson RE, Sinnwell JP, Barman P, Sicotte H, Eckel-Passow JE, Wang L, Kalari KR, Qin R, Kruisselbrink TM, Jimenez RE, Bryce AH, Tan W, Weinshilboum R, Wang L, Kohli M. Determining the frequency of pathogenic germline variants from exome sequencing in patients with castrate-resistant prostate cancer. BMJ Open. 2016 Apr 15;6(4):e010332. doi: 10.1136/bmjopen-2015-010332.

  PMID: 27084275 DERIVED

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Samples with DNA and RNA will be retained.

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Winston Tan, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2013
• First Posted: October 1, 2013
• Study Start: May 30, 2013
• Primary Completion: December 3, 2015
• Study Completion (Estimated): December 15, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)