Hormone Refractory Prostate CancerIMMC-38NCT00133900
Circulating Tumor Cells and Survival in Hormone Refractory Prostate Cancer (HRPC) Patients Receiving Chemotherapy
An observational study of Hormone Refractory Prostate Cancer and Prostate Cancer, run by Immunicon at 1 site in United States.
Trial summary
This study enrolled men with prostate cancer who had failed hormone therapy (as shown by rising prostate-specific antigen [PSA] levels) and who were about to start a new line of chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hormone Refractory Prostate Cancer, Prostate Cancer
- What is being tested?
- Phlebotomy
- Type of treatment
- Surgery or procedure
- How many people
- 276 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Feb 2009
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Oncology patients from academic institutions and private practices
Who may be able to join
- Age > or = 18 years
- Pathological diagnosis of adenocarcinoma of the prostate
- First or later line of chemotherapy
- Serum testosterone < 50ng/mL
- ECOG 0-2
- Serum PSA > or = 5ng/mL
Show all 10Show fewer
- PSA progression (2 rises above a reference value)
- Bone scan within 60 days of enrollment
- Computed tomography (CT) scan
- If measurable disease, bone scans every 6-8 months
Who cannot join
- Systemic radiation
- Prior history of other carcinoma within the last 5 years, except non-melanoma skin cancer
- Brain metastases
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: Circulating Tumor Cells and the Prediction of Overall Survival in Patients With Androgen Independent Prostate Cancer Entering Onto Chemotherapy
This study enrolled men with prostate cancer who had failed hormone therapy (as shown by rising prostate-specific antigen [PSA] levels) and who were about to start a new line of chemotherapy. Blood was drawn prior to the patient receiving chemotherapy and then monthly thereafter for up to 18 months or until disease progression, whichever occurred first. The blood was tested to find circulating tumor cells (CTC) and to count them. The circulating tumor cell levels were studied in relation to the patient's overall survival. Serum was also collected for PSA testing, and additional blood samples were drawn to test for circulating endothelial cells and RNA was isolated for future gene expression testing.
- Being tested
- Phlebotomy
- Keywords
- hormone refractory prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhlebotomyProcedure or surgery
Peripheral blood draws for evaluation of circulating tumor cells
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Metastatic Hormone Refractory Prostate Cancer Patients Receives: Procedure: Phlebotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: Up to 36 months from time of baseline draw
Secondary outcomes (1)
Progression Free Survival
Measured: Up to 36 months after baseline draw
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2005 (estimated)
- Study startDec 2004
- Primary completionFeb 2009 (estimated)
- Study completionFeb 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hormone Refractory Prostate CancerStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immunicon
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ken Pienta, MD, Principal investigator, University of MichiganDerek Raghavan, M.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00133900
- Sponsor's protocol ID
- IMMC-38
- Acronym
- IMMC-38
- Status last verified
- Mar 2008
- First submitted
- 22 Aug 2005
- Last updated
- 28 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Coumans FA, Ligthart ST, Uhr JW, Terstappen LW. Challenges in the enumeration and phenotyping of CTC. Clin Cancer Res. 2012 Oct 15;18(20):5711-8. doi: 10.1158/1078-0432.CCR-12-1585. Epub 2012 Sep 25.
PubMed 23014524
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor Cells and the Prediction of Overall Survival in Patients With Androgen Independent Prostate Cancer Entering Onto Chemotherapy
- ClinicalTrials.gov ID
- NCT00133900
- Acronym / sponsor ID
- IMMC-38 / IMMC-38
- Keywords
- hormone refractory prostate cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 276 participants (actual)
- Lead sponsor
- ImmuniconIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Feb 2009 (estimated)
- Study completion
- Feb 2009 (estimated)
- First posted
- 24 Aug 2005 (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 study enrolled men with prostate cancer who had failed hormone therapy (as shown by rising prostate-specific antigen [PSA] levels) and who were about to start a new line of chemotherapy. Blood was drawn prior to the patient receiving chemotherapy and then monthly thereafter for up to 18 months or until disease progression, whichever occurred first. The blood was tested to find circulating tumor cells (CTC) and to count them. The circulating tumor cell levels were studied in relation to the patient's overall survival. Serum was also collected for PSA testing, and additional blood samples were drawn to test for circulating endothelial cells and RNA was isolated for future gene expression testing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Procedure: PhlebotomyMetastatic Hormone Refractory Prostate Cancer Patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Oncology patients from academic institutions and private practices
Key inclusion criteria (10 listed)
- Age > or = 18 years
- Pathological diagnosis of adenocarcinoma of the prostate
- First or later line of chemotherapy
- Serum testosterone < 50ng/mL
- ECOG 0-2
Key exclusion criteria (3 listed)
- Systemic radiation
- Prior history of other carcinoma within the last 5 years, except non-melanoma skin cancer
- Brain metastases
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 |
|---|---|---|
| PhlebotomyPeripheral blood draws for evaluation of circulating tumor cells | Procedure or surgery | Cohort |
Primary outcome
Overall Survival
Time frame: Up to 36 months from time of baseline draw
1 secondary outcome
Progression Free Survival
Time frame: Up to 36 months after baseline draw
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2009.
- Derived from this study: PubMed 23014524Coumans FA, Ligthart ST, Uhr JW, Terstappen LW. Challenges in the enumeration and phenotyping of CTC. Clin Cancer Res. 2012 Oct 15;18(20):5711-8. doi: 10.1158/1078-0432.CCR-12-1585. Epub 2012 Sep 25.
- 510(k) Premarket Notification SummaryLink provided by the sponsor.
Related trials for Hormone Refractory Prostate Cancer
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RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
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RecruitingPhase 1/2
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RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
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Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
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.
Ken Pienta, MD principal investigator
University of Michigan
Derek Raghavan, M.D. principal investigator
The Cleveland Clinic
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 Refractory Prostate Cancer and Prostate Cancer, run by Immunicon 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 10 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Jul 2009. 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?
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?
Overall Survival (time frame: Up to 36 months from time of baseline draw). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00133900, which also lists 1 linked publication.
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 28 Jul 2009.