Prostate CancerNCT01617174
Observational Longitudinal Study of Pain in Men With Metastatic Castrate-Resistant Prostate Cancer
An observational study of Prostate Cancer, run by Memorial Sloan Kettering Cancer Center.
Trial summary
The first goal of this study is to learn more about the experience of pain and other symptoms in men being treated for advanced prostate cancer. The second goal of the study is to identify reliable ways of measuring pain which will be used in future clinical trials of treatments for advanced prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Webcore telephone survey system
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Jun 2014
- 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: Eligible patients will be recruited from 3 different collaborating sites: MSKCC, John Hopkins, and OHSU. MSKCC will enroll approximately 200 patients, and John Hopkins and OHSU will each enroll approximately 100 patients; 400 participants will be enrolled in total. MSKCC is the coordinating site for this study.
Who may be able to join
- The subject must be ≥ 18 years old on the day of consent.
- The subject is able to understand written and spoken English.
- The patient must have histologically or cytologically confirmed prostate adenocarcinoma.
- The subject must have castration-resistant prostate cancer (CRPC).
- The subject must have metastatic disease involving bone, seen on radiographic imaging (bone scan, CT scan, PET scan, or MRI).
- The subject must be in a castrate state (e.g., currently receiving androgen deprivation therapy or have had an orchiectomy).
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- The subject must be starting any line of systemic treatment post-androgen deprivation/antiandrogen therapy, with any of the following: chemotherapy (e.g., docetaxel, paclitaxel, carboplatin, cabazitaxel, or mitoxantrone); abiraterone acetate; MDV3100; ketoconazole; a clinical trial.
- The subject owns or has regular access to a telephone (cellular or land line).
- The subject is willing and able to self-report pain and analgesic use via an automated telephone system.
- The subject is willing and able to provide informed consent.
Who cannot join
- The subject has small cell or predominantly neuroendocrine differentiated prostate tumor.
About this study
The first goal of this study is to learn more about the experience of pain and other symptoms in men being treated for advanced prostate cancer. The second goal of the study is to identify reliable ways of measuring pain which will be used in future clinical trials of treatments for advanced prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- Webcore telephone survey system
- Keywords
- prostate, pain assessment, 12-110
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Webcore telephone survey systemBehavioural
Patients will report pain and analgesic use through the automated telephone system, for 7 days in a row, once every 6 weeks. Data from diagnostic tests (CT Abdomen/Pelvis, Bone Scan, PSA, and circulating tumor cells) conducted during the study period will be collected from medical records by local personnel and entered into the secure online database quarterly, but no specific tests or schedules will be required in this observational study.
| Study group | Role | What they receive |
|---|---|---|
| assessments completed by patients | A single-arm observational study will be conducted at three institutions in the Prostate Cancer Clinical Trials Consortium (PCCTC): Memorial Sloan-Kettering Cancer Center; Johns Hopkins; and Oregon Health \& Science University. MSKCC is the coordinating center. The target enrollment is 400 patients, with at least 250 experiencing "moderate or worse" pain intensity at baseline, defined as a score of ≥4, the preferred regulatory cutoff. Receives: Behavioral: Webcore telephone survey system |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
Pain score changes will be correlated with each of the following: patient rating of change in pain, as well as changes in patient functional status, analgesic use, and various measures of disease status (imaging, PSA, circulating tumor cells). The distribution-based approach is to estimate meaningful change as one-half a standard deviation of the sample mean pain score.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University, Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Michael Morris, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01617174
- Sponsor's protocol ID
- 12-110
- Status last verified
- Nov 2013
- First submitted
- 8 Jun 2012
- Last updated
- 8 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Longitudinal Study of Pain in Men With Metastatic Castrate-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT01617174
- Acronym / sponsor ID
- 12-110
- Conditions
- Prostate Cancer
- Keywords
- prostate, pain assessment, 12-110
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Oregon Health and Science University, Johns Hopkins University
- Study start
- Jun 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 12 Jun 2012 (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.
The first goal of this study is to learn more about the experience of pain and other symptoms in men being treated for advanced prostate cancer. The second goal of the study is to identify reliable ways of measuring pain which will be used in future clinical trials of treatments for advanced prostate cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| assessments completed by patients | – | Behavioral: Webcore telephone survey systemA single-arm observational study will be conducted at three institutions in the Prostate Cancer Clinical Trials Consortium (PCCTC): Memorial Sloan-Kettering Cancer Center; Johns Hopkins; and Oregon Health \& Science University. MSKCC is the coordinating center. The target enrollment is 400 patients, with at least 250 experiencing "moderate or worse" pain intensity at baseline, defined as a score of ≥4, the preferred regulatory cutoff. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients will be recruited from 3 different collaborating sites: MSKCC, John Hopkins, and OHSU. MSKCC will enroll approximately 200 patients, and John Hopkins and OHSU will each enroll approximately 100 patients; 400 participants will be enrolled in total. MSKCC is the coordinating site for this study.
Key inclusion criteria (10 listed)
- The subject must be ≥ 18 years old on the day of consent.
- The subject is able to understand written and spoken English.
- The patient must have histologically or cytologically confirmed prostate adenocarcinoma.
- The subject must have castration-resistant prostate cancer (CRPC).
- The subject must have metastatic disease involving bone, seen on radiographic imaging (bone scan, CT scan, PET scan, or MRI).
Key exclusion criteria (1 listed)
- The subject has small cell or predominantly neuroendocrine differentiated prostate tumor.
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 |
|---|---|---|
| Webcore telephone survey systemPatients will report pain and analgesic use through the automated telephone system, for 7 days in a row, once every 6 weeks. Data from diagnostic tests (CT Abdomen/Pelvis, Bone Scan, PSA, and circulating tumor cells) conducted during the study period will be collected from medical records by local personnel and entered into the secure online database quarterly, but no specific tests or schedules will be required in this observational study. | Behavioural | assessments completed by patients |
Primary outcome
pain score
Time frame: 2 years
Pain score changes will be correlated with each of the following: patient rating of change in pain, as well as changes in patient functional status, analgesic use, and various measures of disease status (imaging, PSA, circulating tumor cells). The distribution-based approach is to estimate meaningful change as one-half a standard deviation of the sample mean pain score.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2013.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
Michael Morris, MD principal investigator
Memorial Sloan Kettering Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Memorial Sloan Kettering Cancer Center.
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 1 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: withdrawn, as of the sponsor's last update on 8 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
pain score (time frame: 2 years). 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 8 Nov 2013.