CTC Immune Checkpoint
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ClinicalTrials.gov Identifier: NCT02456571 |
Recruitment Status :
Completed
First Posted : May 28, 2015
Last Update Posted : July 9, 2019
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Condition or disease | Intervention/treatment |
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Prostate Cancer | Device: CTC biomarker expression prevalence |
Study Type : | Observational |
Actual Enrollment : | 38 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Defining the Relevant Immune Checkpoints Expressed on Metastatic Prostate Cancer Circulating Tumor Cells |
Actual Study Start Date : | November 2016 |
Actual Primary Completion Date : | June 13, 2019 |
Actual Study Completion Date : | June 13, 2019 |

Group/Cohort | Intervention/treatment |
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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.
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Device: CTC biomarker expression prevalence |
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.
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Device: CTC biomarker expression prevalence |
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.
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Device: CTC biomarker expression prevalence |
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)
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Device: CTC biomarker expression prevalence |
- Change in expression of four immune checkpoint biomarkers (PD-L1, PD-L2, B7-H3, and CTLA-4) on circulating tumor cells (CTCs). [ Time Frame: Baseline to 12 weeks ]
- Change in expression of four immune checkpoint biomarkers (PD-L1, PD-L2, B7-H3, and CTLA-4) on circulating tumor cells (CTCs). [ Time Frame: Baseline to 14 months (expected time of progression) ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients will be eligible for inclusion in this study only if all of the following criteria apply:
- Histologically confirmed diagnosis of adenocarcinoma of the prostate. Small cell or neuroendocrine tumors of the prostate are also permitted.
- 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.
- Age ≥ 18 years.
- 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
- 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)
- Patient planning to start sipuleucel-T.
- Enrollment prior to the initiation of sipuleucel-T.
B) mCRPC with visceral or high risk disease pre-abiraterone/enzalutamide
- 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)
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Visceral OR high risk disease - must meet one of the following categories:
- Visceral disease: Radiographic evidence of liver, adrenal, pulmonary, or brain metastases
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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
- Patient planning to start abiraterone acetate or enzalutamide.
- Enrollment prior to the initiation of abiraterone acetate or enzalutamide.
C) Newly diagnosed metastatic castration sensitive prostate cancer (mCSPC) starting androgen deprivation therapy
- Evidence of metastatic disease on radiographic imaging
- Enrollment within 2 weeks of initiation of androgen deprivation therapy (ADT).
- Lack of history of hypogonadism
D) Enzalutamide or abiraterone acetate resistant mCRPC
- 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)
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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:
- 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).
- Treatment with an anthracycline (including mitoxantrone) within 1 week of CTC collection, as anthracyclines cause auto-fluorescence of cells.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02456571
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 |
Principal Investigator: | Andrew J Armstrong, MD | Duke University |
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT02456571 |
Other Study ID Numbers: |
Pro00063296 |
First Posted: | May 28, 2015 Key Record Dates |
Last Update Posted: | July 9, 2019 |
Last Verified: | July 2019 |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |