Validation of the Prostate Cancer Assay - Beta+Pivotal (VPCA-B+PIV)

Prospective, Multi-Center Validation of the Prostate Cancer Assay

The Prostate Cancer Assay performance of Celsee Diagnostics circulating tumor cell (CTC) analysis system will be validated in patients diagnosed with metastatic prostate cancer. It will demonstrate substantial performance equivalency to a CTC Assay predicate device.

Study Overview

• Status: Withdrawn
• Conditions: Metastatic Prostate Cancer, CTC
• Intervention / Treatment: Device: Blood Draw

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Males 18 years and above; Metastatic prostate cancer to the bone as documented by positive bone scan imaging

Description

Inclusion Criteria:

• • Male aged 18 years and above

  • Be willing to sign an informed consent document indicating that the subject understands the purpose of and procedures required for the study and are willing to participate in the study
  • Be willing/able to adhere to the prohibitions and restrictions specified in this protocol
  • Eastern cooperative group (ECOG) performance status ≤2
  • Documented histologically confirmed adenocarcinoma of the prostate
  • Metastatic prostate cancer to the bone as documented by positive bone scan imaging
  • CRPC patient being considered for systemic therapy or in between lines of therapies (>= 14 days from prior treatment) for metastatic disease. Patient must have evidence of castrate resistant prostate cancer as evidenced by a confirmed rising PSA (per Prostate Cancer Working Group 2 [PCWG2] criteria) and a castrate serum testosterone level (i.e. ≤ 50 mg/dl).

Exclusion Criteria:

• • Subjects actively receiving systemic therapy regimens, or between lines of therapies (< 14 days from prior treatment)

  • Have any condition that, in the opinion of the investigator, would compromise the wellbeing of the subject or the study or prevent the subject from meeting or performing study requirements
  • Active infection or other medical condition that would make corticosteroids (i.e. prednisone) use contraindicated
  • Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg) Patients with a history of hypertension are allowed provided blood pressure is controlled by antihypertensive treatment
  • Severe hepatic impairment (Child-Pugh Class C)
  • History of pituitary or adrenal dysfunction (note: the use of daily steroids does not exclude someone from participating in this study)
  • Have poorly controlled diabetes (HgB A1C ≥ 8%)
  • Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.
  • Abnormal bone marrow function (absolute neutrophil count [ANC] < 1500/mm3, platelet count <100,000/mm3, hemoglobin <9 g/dL)
  • Abnormal liver function (bilirubin > upper limit of normal [ULN]; AST and/or ALT > 1.5 x ULN concomitant with alkaline phosphatase > 2.5 x ULN)
  • Abnormal kidney function (serum creatinine ≥ 2 x upper limit of normal)
  • Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, unstable atrial fibrillation, or New York Heart Association (NYHA) Class III-IV heart disease
  • History of ventricular tachyarrhythmia within the past 5 years

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Beta Cutoff; Assay	Device: Blood Draw; Blood draws only - non-diagnostic, non-treatment
Pivotal; Assay	Device: Blood Draw; Blood draws only - non-diagnostic, non-treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confirmation of the clinical utility of the cutoff level for the Prostate Cancer Assay for prognosis of progression free survival (PFS) in comparison to the predicate device, CellSearch CTC Assay	"CTC negative" means a level of CTCs below the cutoff indicating lower risk for progression (i.e. PFS, and "CTC positive" means a level of CTCs at or above the cutoff indicating higher risk for progression (i.e. shorter PFS).	9 months

Collaborators and Investigators

• Sponsor: Celsee Diagnostics
• Investigators: Study Director: Yixin Wang, Ph.D., Celsee Diagnostics

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2016
• Primary Completion (Anticipated): April 1, 2017
• Study Completion (Anticipated): September 1, 2017

Study Registration Dates

• First Submitted: March 24, 2016
• First Submitted That Met QC Criteria: April 13, 2016
• First Posted (Estimate): April 19, 2016

Study Record Updates

• Last Update Posted (Actual): March 26, 2019
• Last Update Submitted That Met QC Criteria: March 22, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: Celsee CA1001.v1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No