Prostate CancerTOPCOPNCT02512185
Towards Optimal Prescription of Chemotherapy in Prostate Cancer
An observational study of Prostate Cancer, run by University Health Network, Toronto at 4 sites in Canada.
Trial summary
This study will examine the impact of modern treatments for metastatic Castrate Resistant Prostate Cancer (mCRPC) on several relevant 'geriatric' domains such as daily function, objective physical function, and falls. Read more about this study
- Who is it for?
- Ages 65 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 206 participants
- Where
- 4 sitesCanada
- Study dates
- Jul 2015to 31 Dec 2019
- 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 65 years and older
- Men only
- No healthy volunteers
- Older adult
Study population: Men 65 and older starting first line chemotherapy, or Abiraterone, or Enzalutamide for mCRPC
Who may be able to join
- At least 65 years of age
- Diagnosed with prostate cancer with evidence of clinical and/or radiographic evidence of progression despite adequate androgen deprivation therapy and achievement of castration (total testosterone level <1.7 nmol/L measured within 6 months of enrollment)
- Among men starting either abiraterone or enzalutamide, no prior chemotherapy/abiraterone/enzalutamide. Among men starting first-line chemotherapy, commencing docetaxel but can have had either prior abiraterone or enzalutamide
Who cannot join
- Unable to speak English fluently.
- Severe neuropsychiatric abnormalities that prevent study participation.
- Limited life expectancy (<3 months) as estimated by the primary oncologist.
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
Kingston Health Sciences Centre -KGH
Kingston, Ontario, K7L 2V7
Odette Cancer Centre
Toronto, Ontario, M4N 3M5
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
About this study
Official title: TOward Personalizing Care for Older Men With mCRPC - Understanding and Predicting Treatment Toxicities (the TOPCOP Study)
This study will examine the impact of modern treatments for metastatic Castrate Resistant Prostate Cancer (mCRPC) on several relevant 'geriatric' domains such as daily function, objective physical function, and falls. Additionally, the investigators study whether frailty is associated with worse outcomes, and whether it is possible to predict the risk of severe chemotherapy toxicity in older men.
Read the detailed description
Our primary aims are (a) to examine the impact of pre-treatment frailty on 'elder-relevant' outcomes including daily function, objective physical function, falls, quality of life (QOL), and early treatment discontinuation; (b) to determine whether the Hurria/Cancer and Aging Research Group (CARG) tool is able to predict severe (grade 3+) chemotherapy toxicity in men starting chemotherapy. Our secondary aim is to understand the impact of abiraterone and enzalutamide on 'elder-relevant' outcomes.
This is a prospective multicentre observational study. The investigators will enroll men age 65 or older with mCRPC who are starting (a) first-line chemotherapy; (b) abiraterone; or (c) enzalutamide. Assessments will occur prior to starting treatment and every 2 months thereafter until the end of treatment.
As treatment options become more complex in older men with mCRPC, understanding and predicting a wide range of treatment toxicities is important and will aid decision-making and management.
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Chemotherapy, mCRPC
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy | Men starting first-line chemotherapy for mCRPC (typically Docetaxel and Prednisone) | |
| Abiraterone | Men with mCRPC starting Abiraterone | |
| Enzalutamide | Men with mCRPC starting Enzalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily function assessed by questionnaires
Daily function
Measured: Participants will be followed for the duration of treatment up to 2 years
Objective physical function
Will be assessed by 3 physical performance measures
Measured: Participants will be followed for the duration of treatment up to 2 years
Grade 3+ toxicity using Common Terminology Criteria for Adverse Events (CTC-AE) version 4.0
Toxicity
Measured: Participants will be followed for the duration of treatment up to 2 years
Number of falls provided by the participant
Falls
Measured: Participants will be followed for the duration of treatment up to 2 years
Body fat percentage will be measured using a Tanita 300A analyzer
Body composition analysis
Measured: Participants will be followed for the duration of treatment up to 2 years
Secondary outcomes (2)
Quality of Life (QOL)
FACT-G and FACT-P (specific for prostate cancer) questionnaires will be administered
Measured: Participants will be followed for the duration of treatment up to 2 years
The Montreal Cognitive Assessment (MoCA test) and Trail making tests A&B
Cognition composite
Measured: Participants will be followed for the duration of treatment 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 posted30 Jul 2015 (estimated)
- Study startJul 2015
- Primary completion30 Apr 2019
- Study completion31 Dec 2019
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 University Health Network, TorontoThe 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
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Prostate Cancer Canada
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512185
- Sponsor's protocol ID
- 15-9075
- Acronym
- TOPCOP
- Status last verified
- Aug 2020
- First submitted
- 17 Jul 2015
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TOward Personalizing Care for Older Men With mCRPC - Understanding and Predicting Treatment Toxicities (the TOPCOP Study)
- ClinicalTrials.gov ID
- NCT02512185
- Acronym / sponsor ID
- TOPCOP / 15-9075
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Chemotherapy, mCRPC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Prostate Cancer Canada
- Study start
- Jul 2015 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 30 Jul 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 study will examine the impact of modern treatments for metastatic Castrate Resistant Prostate Cancer (mCRPC) on several relevant 'geriatric' domains such as daily function, objective physical function, and falls. Additionally, the investigators study whether frailty is associated with worse outcomes, and whether it is possible to predict the risk of severe chemotherapy toxicity in older men.
Detailed description
Our primary aims are (a) to examine the impact of pre-treatment frailty on 'elder-relevant' outcomes including daily function, objective physical function, falls, quality of life (QOL), and early treatment discontinuation; (b) to determine whether the Hurria/Cancer and Aging Research Group (CARG) tool is able to predict severe (grade 3+) chemotherapy toxicity in men starting chemotherapy. Our secondary aim is to understand the impact of abiraterone and enzalutamide on 'elder-relevant' outcomes.
This is a prospective multicentre observational study. The investigators will enroll men age 65 or older with mCRPC who are starting (a) first-line chemotherapy; (b) abiraterone; or (c) enzalutamide. Assessments will occur prior to starting treatment and every 2 months thereafter until the end of treatment.
As treatment options become more complex in older men with mCRPC, understanding and predicting a wide range of treatment toxicities is important and will aid decision-making and management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | – | –Men starting first-line chemotherapy for mCRPC (typically Docetaxel and Prednisone) |
| Abiraterone | – | –Men with mCRPC starting Abiraterone |
| Enzalutamide | – | –Men with mCRPC starting Enzalutamide |
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Men 65 and older starting first line chemotherapy, or Abiraterone, or Enzalutamide for mCRPC
Key inclusion criteria (3 listed)
- At least 65 years of age
- Diagnosed with prostate cancer with evidence of clinical and/or radiographic evidence of progression despite adequate androgen deprivation therapy and achievement of castration (total testosterone level <1.7 nmol/L measured within 6 months of enrollment)
- Among men starting either abiraterone or enzalutamide, no prior chemotherapy/abiraterone/enzalutamide. Among men starting first-line chemotherapy, commencing docetaxel but can have had either prior abiraterone or enzalutamide
Key exclusion criteria (3 listed)
- Unable to speak English fluently.
- Severe neuropsychiatric abnormalities that prevent study participation.
- Limited life expectancy (<3 months) as estimated by the primary oncologist.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Daily function assessed by questionnaires
Time frame: Participants will be followed for the duration of treatment up to 2 years
Daily function
Objective physical function
Time frame: Participants will be followed for the duration of treatment up to 2 years
Will be assessed by 3 physical performance measures
Grade 3+ toxicity using Common Terminology Criteria for Adverse Events (CTC-AE) version 4.0
Time frame: Participants will be followed for the duration of treatment up to 2 years
Toxicity
Number of falls provided by the participant
Time frame: Participants will be followed for the duration of treatment up to 2 years
Falls
Body fat percentage will be measured using a Tanita 300A analyzer
Time frame: Participants will be followed for the duration of treatment up to 2 years
Body composition analysis
2 secondary outcomes
Quality of Life (QOL)
Time frame: Participants will be followed for the duration of treatment up to 2 years
The Montreal Cognitive Assessment (MoCA test) and Trail making tests A&B
Time frame: Participants will be followed for the duration of treatment up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by University Health Network, Toronto at 4 sites in Canada.
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 3 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: finished, as of the sponsor's last update on 19 Aug 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 Canada. 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?
Daily function assessed by questionnaires (time frame: Participants will be followed for the duration of treatment up to 2 years). The study lists 5 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 19 Aug 2020.