Detection of ARv7 in the Plasma of Men With Advanced Metastatic Castrate Resistant Prostate Cancer (MCRP)

NCT03236688 | Suspended

• 1 other identifier: ECT2015-004
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Demonstrate detection of ARv7 splice variant transcripts from exosomes in the circulation of MCRPC patients pre and post treatment with selective Androgen pathway inhibitors (i.e. abiraterone and enzalutamide)

Conditions

Metastatic Castrate Resistant Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Detection of ARv7 splice variant in the circulation of MCRPC patients. PSA response rate in ARv7 positive patients.

  The detection of ARv7 splice variants in samples will be considered both binary: positive or negative/not assessable and level based. ARv7 splice variants from exosomes will be detectable from baseline in 50% of both API; PSA response rates will be 10% or less in ARv7 positive patients. With a sample of 30 patients (as reported in the NEJM study) per cohort would allow the study to have an 85% power to detect a difference of 50 percentage points in PSA response rates, with the use of a two-sided test at an alpha level of 0.1.

  Two years

Secondary Outcomes (1)

• Detection of ARv7 splice variant in the circulation of MCRPC patients. PSA response rate in ARv7 negative patients.

  Two years

Study Arms (1)

MCRPC

Metastatic Castrate Resistant Prostate Cancer (MCRPC) Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Community sample

You may qualify if:

• Participants must have histologically confirmed diagnosis of adenocarcinoma of the prostate.
• Clinical or radiographic evidence of metastatic disease.
• Planned therapy with either enzalutamide or abiraterone acetate within the coming 6 weeks.
• Evidence of disease progression on or following most recent therapy as evidenced by the following:
• Radiographic evidence of disease progression as defined by one or more new bone scan lesions.
• Growth of soft tissue / visceral metastases to greater than one centimeter in longest diameter.
• Progressive disease despite 'castration levels' of serum testosterone (\<50ng/dL with continued androgen deprivation therapy.
• At least two of the following high risk features during screening for rapid disease progression:
• Anemia with a hemoglobin \<12.0 g/dL
• Elevated alkaline phosphatase
• High lactate dehydrogenase (LDH)
• Presence of visceral metastasis on imaging
• Presence of clinically significant pain requiring opioid analgesics.
• PSA doubling time under 3 months on most recent therapy
• PSA values obtained 2 or more weeks apart, with last value being 2.0ng/mL or higher.

You may not qualify if:

• Receiving or intend to receive concurrent chemotherapy
• Hepatitis (all types) in patient's medical record
• HIV documented in patient's medical record
• History of intercurrent or past medical history or psychiatric illness that would make participation in a blood drawing protocol difficult or not feasible.

Sponsors & Collaborators

• Exosome Diagnostics, Inc.: lead
• Yale University: collaborator

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

10-20 mL of whole blood collected in K2EDTA Plasma Preparation Tubes (PPT) will be acquired via standard venipuncture and processed to plasma.

Study Officials

• Roger Tun

  Exosome Diagnostics, Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: August 2, 2017
• Study Start: February 1, 2016
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 6, 2022

Record last verified: 2022-10

Locations

US (1)