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Metastatic Castrate-Resistant Prostate CancerNCT02008058

Observational Longitudinal Study of Pain in Men With Metastatic Castrate-Resistant Prostate Cancer

An observational study of Metastatic Castrate-Resistant Prostate Cancer, run by UNC Lineberger Comprehensive Cancer Center at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a single-arm observational longitudinal study in of patients with metastatic castrate-resistant prostate cancer designed to assess the longitudinal trajectory of pain and other symptoms. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Survey
How many people
213 participants
Where
4 sitesUnited States
Study dates
23 Jan 2014to 30 Sep 2017
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 clinic

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 treatment post-androgen deprivation/antiandrogen therapy, such as the following: chemotherapy (e.g., docetaxel, paclitaxel, carboplatin, cabazitaxel, or mitoxantrone); abiraterone acetate; MDV3100; ketoconazole; sipuleucel-T; Radium 223.
  • 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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Johns Hopkins University

    Baltimore, Maryland, 21231

  • Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • University of Washington

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: LCCC 1231: Observational Longitudinal Study of Pain in Men With Metastatic Castrate-Resistant Prostate Cancer

This is a single-arm observational longitudinal study in of patients with metastatic castrate-resistant prostate cancer designed to assess the longitudinal trajectory of pain and other symptoms.

Read the detailed description

This is a single-arm observational longitudinal study in of patients with metastatic castrate-resistant prostate cancer designed to assess the longitudinal trajectory of pain and other symptoms. The study aims to address several key methodological questions that will inform the design of future clinical trials with symptom endpoints in this population, including: the definition of "clinically meaningful" pain; criteria for concluding a clinically meaningful pain reduction; criteria for concluding clinically meaningful pain progression; reliable methods quantifying analgesic use (given that "equianalgesic tables" and "point scoring systems" are generally considered unreliable by pain researchers and regulatory agencies , , ); ideal recall periods for pain questions; tradeoffs of different frequencies of symptom reporting; symptom trajectories over time; and associations of pain scores with other metrics used in prostate cancer research (imaging, PSA values, circulating tumor cells, etc).

Being tested
Survey
Keywords
Metastatic Castrate-Resistant Prostate Cancer, LCCC 1231, Lineberger Comprehensive Cancer Center, UNC Lineberger, Prostate Cancer, Pain
Medical subject headings
Prostatic Neoplasms, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurveyBehavioural

    Also called Webcore telephone survey system

    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. Patients will remain on study for up to 26 months (slightly longer than the expected median survival in this population based on data from docetaxel, abiraterone, and MDV3100 pivotal phase 3 trials).

Study groups in NCT02008058
Study groupRoleWhat they receive
Single ArmSurveys, diaries, clinical assessments of men with metastatic castrate-resistant prostate cancer
Receives: Behavioral: Survey

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of pain palliation responders

    Determine the proportion of pain palliation responders and the proportion experiencing pain progression will be presented along with 95% confidence intervals.

    Measured: 6 weeks

Secondary outcomes (5)

  1. Clinical significance of pain score changes

    Determine the clinical significance of pain score changes. Pain score changes will be compared with each of the following "anchors": 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). ROC curves derived using logistic regression analyses will be used to characterize the association between change in pain scores and clinically important improvement (defined by anchor variables).

    Measured: 6 weeks

  2. Prevalence and trajectory of pain progression and pain palliation

    Descriptive statistics, including Kaplan-Meier, will be used to report findings for the proportion of asymptomatic men who ultimately develop pain, the median time until asymptomatic men develop pain, the median time until men with pain experience pain progression, and the median time until men with pain experience pain palliation.

    Measured: 3 weeks

  3. Quantifying analgesic medication use

    Three different approaches to calculating a single value to represent total analgesic use will be compared: 1) equianalgesic tables published in guidelines of the National Comprehensive Cancer Network (NCCN) which convert various drugs and doses to "morphine equivalents"; 2) point scoring systems used in prior pivotal phase 3 trials based on the World Health Organization analgesic ladder in which lower points are assigned to weaker agents/doses and vice versa for stronger agents/doses; and 3) individual drug dose quantification, a dose recently suggested by the FDA but never empirically evaluated, in which each analgesic is considered individually and a 25% change in dose is considered an increase or decrease for each.

    Measured: 26 months

  4. Frequency of pain reporting

    Seven consecutive days of reporting a pain item with a 24-hour recall item will be compared with a single administration of a pain item with a 7-day recall, in order to evaluate if the latter alone is sufficient for measuring pain.

    Measured: 7 days

  5. Web-avidity of patients

    Identify the web-avidity of patients by summarizing patients' responses to questionnaire items about their use of internet and email.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2013 (estimated)
  2. Study start23 Jan 2014
  3. Primary completion31 Mar 2017
  4. Study completion30 Sep 2017

Resources

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
213 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02008058
Sponsor's protocol ID
LCCC 1231
Other IDs
12-2562
Status last verified
Apr 2019
First submitted
6 Dec 2013
Last updated
30 Mar 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Metastatic Castrate-Resistant Prostate Cancer, run by UNC Lineberger Comprehensive Cancer Center at 4 sites 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 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: finished, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 pain palliation responders (time frame: 6 weeks). 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 NCT02008058.

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 30 Mar 2020.

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