CTC Immune Checkpoint

NCT ID: NCT02456571

Last Updated: 2019-07-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 38 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2019-06-13

Brief Summary

This pilot study will explore the prevalence of expression of four immune checkpoint biomarkers on circulating tumor cells (CTCs) from men with metastatic prostate cancer that are captured by EpCAM via the CellSearch method, and specifically defined as co expressing DAPI and cytokeratin, and lacking CD45 expression.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group A

men with mCRPC starting sipuleucel-T (Provenge) with or without abiraterone acetate or enzalutamide will have CTC enumeration and immune checkpoint characterization at baseline, 3 months, 4-12 weeks after completion of sipuleucel-T, and at progression.

CTC biomarker expression prevalence

Intervention Type: DEVICE

Group B

men with mCRPC with visceral or high risk disease pre-abiraterone/enzalutamide will have CTC enumeration and immune checkpoint characterization at baseline, 3 months, and progression.

CTC biomarker expression prevalence

Intervention Type: DEVICE

Group C

men with high volume metastatic castration sensitive prostate cancer (mCSPC) starting hormonal therapy and docetaxel chemotherapy or who decline docetaxel chemotherapy will have CTC enumeration and immune checkpoint characterization at baseline, 3 months, and progression.

CTC biomarker expression prevalence

Intervention Type: DEVICE

Group D

men with enzalutamide or abiraterone acetate resistant mCRPC will have CTC enumeration and immune checkpoint characterization at baseline (i.e. progression on enzalutamide or abiraterone acetate) and 4-12 weeks after completion of next therapy (ex. radium-223 or chemotherapy)

CTC biomarker expression prevalence

Intervention Type: DEVICE

Interventions

CTC biomarker expression prevalence

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Histologically confirmed diagnosis of adenocarcinoma of the prostate. Small cell or neuroendocrine tumors of the prostate are also permitted.

2. Clinical or radiographic evidence of progressive metastatic disease, with progression defined as a rising PSA, new metastatic lesions (bone or soft tissue), or radiographic evidence of tumor growth on CT or MRI.

3. Age ≥ 18 years.

4. Ability to understand and the willingness to sign a written informed consent document.

In addition to meeting all of the above criteria, patients must meet all of the criteria for one of the following groups:

A) mCRPC starting sipuleucel-T (Provenge) with or without abiraterone acetate or enzalutamide

1. For patients with adenocarcinoma of the prostate (not applicable for patients with small cell or neuroendocrine tumors of the prostate, or those receiving ADT therapy): Castrate levels of testosterone (≤ 50 ng/dl)

2. Patient planning to start sipuleucel-T.

3. Enrollment prior to the initiation of sipuleucel-T.

B) mCRPC with visceral or high risk disease pre-abiraterone/enzalutamide

1. For patients with adenocarcinoma of the prostate (not applicable for patients with small cell or neuroendocrine tumors of the prostate, or those receiving ADT therapy): Castrate levels of testosterone (≤ 50 ng/dl)

2. Visceral OR high risk disease - must meet one of the following categories:

• Visceral disease: Radiographic evidence of liver, adrenal, pulmonary, or brain metastases
• High risk disease: Presence of at least 2 of the following factors:

• Bone pain requiring opioids
• Anemia (Hgb <13 g/dL)
• Bone scan progression at baseline
• >2 sites of metastatic disease
• Karnofsky Performance Status (KPS) ≤ 70
• PSA doubling time <3 months

3. Patient planning to start abiraterone acetate or enzalutamide.

4. Enrollment prior to the initiation of abiraterone acetate or enzalutamide.

C) Newly diagnosed metastatic castration sensitive prostate cancer (mCSPC) starting androgen deprivation therapy

1. Evidence of metastatic disease on radiographic imaging

2. Enrollment within 2 weeks of initiation of androgen deprivation therapy (ADT).

3. Lack of history of hypogonadism

D) Enzalutamide or abiraterone acetate resistant mCRPC

1. For patients with adenocarcinoma of the prostate (not applicable for patients with small cell or neuroendocrine tumors of the prostate, or those receiving ADT therapy): Castrate levels of testosterone (≤ 50 ng/dl)

2. Evidence of disease progression on or following enzalutamide or abiraterone acetate, as defined by one of the following:

• Radiographic evidence of disease progression as defined by new bone scan lesions or growth of existing soft tissue/visceral/lymph node/bone metastases as determined by the investigator
• Clinical progression of disease with cutaneous lesions or palpable lesions in absence of radiographic progression

Exclusion Criteria

1. History of intercurrent or past medical or psychiatric illness that would make participation in a blood drawing protocol difficult or not feasible at the discretion of the principal investigator or co-investigator(s).

2. Treatment with an anthracycline (including mitoxantrone) within 1 week of CTC collection, as anthracyclines cause auto-fluorescence of cells.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew J Armstrong, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00063296

Identifier Type: -

Identifier Source: org_study_id