Hormone-Resistant Prostate CancerNCT02370355
Molecular Characterization of CTCs and ctDNA in Blood and Plasma Samples From Patients With Metastatic and/or Hormone-Resistant Prostate Cancer
An observational study of Hormone-Resistant Prostate Cancer and Metastatic Prostate Carcinoma, run by University of Southern California at 1 site in United States.
Trial summary
This research trial studies molecular characterization of circulating tumor cells (CTCs) and circulating tumor (ct) deoxyribonucleic acid (DNA) in blood and plasma samples from patients with prostate cancer that has spread to other places in the body and/or has not responded to previous treatment with hormones. Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Hormone-Resistant Prostate Cancer, Metastatic Prostate Carcinoma
- What is being tested?
- Cytology Specimen Collection Procedure and Laboratory Biomarker Analysis
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Dec 2014to 8 Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastatic and/or hormone-resistant prostate cancer consented under University of Southern California (USC) protocols IRB numbers 10-00006 and 11-004500 or treated at the USC/Westside Cancer Center, USC/Norris Comprehensive Cancer Center, or LAC + USC Medical Center.
Who may be able to join
- GROUP I: Samples for Group I will be selected from existing sample sets obtained from concluded studies (USC IRB #'s 10-00006 and 11-00450)
- GROUP I: Excess plasma collected and stored in these trials from patients treated with abiraterone or enzalutamide will be used for the molecular analysis of the current protocol
- GROUP II: The second group of samples (Group 2) will involve prospective collection of peripheral blood from patients with advanced, treatment-resistant metastatic prostate cancer
- GROUP II: Histologic documentation of prostate cancer
- GROUP II: Metastatic cancer diagnosed by imaging and other clinical criteria
- GROUP II: Treatment-resistance determined by at least one of the following factors: increase in prostate-specific antigen (PSA) value over a baseline measurement; increase in size or number of metastatic deposits determined on imaging; and/or progression in cancer related symptoms
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Assessment of Novel Biomarkers in Patients With Metastatic Castration Resistant Prostate Cancer
This research trial studies molecular characterization of circulating tumor cells (CTCs) and circulating tumor (ct) deoxyribonucleic acid (DNA) in blood and plasma samples from patients with prostate cancer that has spread to other places in the body and/or has not responded to previous treatment with hormones. Studying samples of blood and plasma collected from patients with prostate cancer before, during, and/or after treatment in the laboratory may help doctors learn more about changes that occur in DNA and identify the development of drug resistance.
Read the detailed description
PRIMARY OBJECTIVES:
- Perform molecular analysis of plasma samples from 25 patients with metastatic prostate cancer collected before and during treatment of the disease with abiraterone acetate (Zytiga) or enzalutamide (Xtandi).
II. Perform molecular characterization of circulating tumor cells (CTCs) and plasma collected from 75 patients with progressing advanced metastatic prostate cancer.
OUTLINE: Patients are assigned to 1 of 2 groups based on the timing of specimen collection.
GROUP I: Previously collected plasma samples are analyzed for ctDNA via polymerase chain reaction (PCR) and next generation sequencing (NSG).
GROUP II: Patients undergo collection of blood samples before and following systemic therapy for analysis of CTC enumeration, ribonucleic acid (RNA) expression, and ctDNA via PCR and NSG.
- Being tested
- Cytology Specimen Collection Procedure, Laboratory Biomarker Analysis
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytology Specimen Collection ProcedureOther
Also called Cytologic Sampling
Undergo collection of blood samples
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (retrospective analysis) | Previously collected plasma samples are analyzed for ctDNA via PCR and NSG. Receives: Other: Laboratory Biomarker Analysis | |
| Group II (prospective analysis) | Patients undergo collection of blood samples before and following systemic therapy for analysis of CTC enumeration, RNA expression, and ctDNA via PCR and NSG. Receives: Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with elevated CTCs
Descriptive statistics will also be applied to summarize levels of CTC numbers. The predominant statistical approaches will include correlation indices and mean comparisons to explore relations within the full data set and between clinical variables and expression data. The predominant statistical approaches will include correlation indices and mean comparisons to explore relations within the full data set and between clinical variables and expression data. The proportion of patients with elevated CTCs will be estimated using a 90% confidence interval.
Measured: Up to 2 years
Expression of individual markers according to clinical stage, serum PSA, and pathologic grade
Descriptive statistics will also be applied to summarize expression of individual markers according to clinical variables (clinical stage, serum PSA, pathologic grade, etc). The predominant statistical approaches will include correlation indices and mean comparisons to explore relations within the full data set and between clinical variables and expression data.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study start23 Dec 2014
- Primary completion8 Jun 2016
- Study completion8 Jun 2016
Why it stopped: Sponsor decided not to pursue study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone-Resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mitchell Gross, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02370355
- Sponsor's protocol ID
- 4P-14-6
- Other IDs
- NCI-2014-02682, HS-14-00861, 4P-14-6, P30CA014089
- Status last verified
- Apr 2017
- First submitted
- 17 Feb 2015
- Last updated
- 17 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Novel Biomarkers in Patients With Metastatic Castration Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT02370355
- Acronym / sponsor ID
- 4P-14-6
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor decided not to pursue study
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 23 Dec 2014 (actual)
- Primary completion
- 8 Jun 2016 (actual)
- Study completion
- 8 Jun 2016 (actual)
- First posted
- 24 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research trial studies molecular characterization of circulating tumor cells (CTCs) and circulating tumor (ct) deoxyribonucleic acid (DNA) in blood and plasma samples from patients with prostate cancer that has spread to other places in the body and/or has not responded to previous treatment with hormones. Studying samples of blood and plasma collected from patients with prostate cancer before, during, and/or after treatment in the laboratory may help doctors learn more about changes that occur in DNA and identify the development of drug resistance.
Detailed description
PRIMARY OBJECTIVES:
- Perform molecular analysis of plasma samples from 25 patients with metastatic prostate cancer collected before and during treatment of the disease with abiraterone acetate (Zytiga) or enzalutamide (Xtandi).
II. Perform molecular characterization of circulating tumor cells (CTCs) and plasma collected from 75 patients with progressing advanced metastatic prostate cancer.
OUTLINE: Patients are assigned to 1 of 2 groups based on the timing of specimen collection.
GROUP I: Previously collected plasma samples are analyzed for ctDNA via polymerase chain reaction (PCR) and next generation sequencing (NSG).
GROUP II: Patients undergo collection of blood samples before and following systemic therapy for analysis of CTC enumeration, ribonucleic acid (RNA) expression, and ctDNA via PCR and NSG.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (retrospective analysis) | – | Other: Laboratory Biomarker AnalysisPreviously collected plasma samples are analyzed for ctDNA via PCR and NSG. |
| Group II (prospective analysis) | – | Other: Cytology Specimen Collection Procedure, Other: Laboratory Biomarker AnalysisPatients undergo collection of blood samples before and following systemic therapy for analysis of CTC enumeration, RNA expression, and ctDNA via PCR and NSG. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic and/or hormone-resistant prostate cancer consented under University of Southern California (USC) protocols IRB numbers 10-00006 and 11-004500 or treated at the USC/Westside Cancer Center, USC/Norris Comprehensive Cancer Center, or LAC + USC Medical Center.
Key inclusion criteria (6 listed)
- GROUP I: Samples for Group I will be selected from existing sample sets obtained from concluded studies (USC IRB #'s 10-00006 and 11-00450)
- GROUP I: Excess plasma collected and stored in these trials from patients treated with abiraterone or enzalutamide will be used for the molecular analysis of the current protocol
- GROUP II: The second group of samples (Group 2) will involve prospective collection of peripheral blood from patients with advanced, treatment-resistant metastatic prostate cancer
- GROUP II: Histologic documentation of prostate cancer
- GROUP II: Metastatic cancer diagnosed by imaging and other clinical criteria
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytology Specimen Collection ProcedureAlso: Cytologic SamplingUndergo collection of blood samples | Other | Group II (prospective analysis) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Group I (retrospective analysis), Group II (prospective analysis) |
Primary outcome
Proportion of patients with elevated CTCs
Time frame: Up to 2 years
Descriptive statistics will also be applied to summarize levels of CTC numbers. The predominant statistical approaches will include correlation indices and mean comparisons to explore relations within the full data set and between clinical variables and expression data. The predominant statistical approaches will include correlation indices and mean comparisons to explore relations within the full data set and between clinical variables and expression data. The proportion of patients with elevated CTCs will be estimated using a 90% confidence interval.
Expression of individual markers according to clinical stage, serum PSA, and pathologic grade
Time frame: Up to 2 years
Descriptive statistics will also be applied to summarize expression of individual markers according to clinical variables (clinical stage, serum PSA, pathologic grade, etc). The predominant statistical approaches will include correlation indices and mean comparisons to explore relations within the full data set and between clinical variables and expression data.
Results and safety
The study was stopped early (reason given: Sponsor decided not to pursue study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchell Gross principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hormone-Resistant Prostate Cancer and Metastatic Prostate Carcinoma, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor decided not to pursue study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with elevated CTCs (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2017.