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PROState Pathway Embedded Comparative Trial (IP3-PROSPECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04400656
Recruitment Status : Recruiting
First Posted : May 22, 2020
Last Update Posted : April 19, 2021
Sponsor:
Collaborators:
Imperial Clinical Trials Unit (ICTU)
Wellcome Trust
Information provided by (Responsible Party):
Imperial College London

Brief Summary:

The proposal will explore a trial design called the cohort-multiple RCT (cmRCT) or as it has been recently coined, the Trials WithIn Cohorts (TWICS) design. This design has been used in a number of disease areas, both benign and cancer. Prostate conditions have been chosen since they are extremely common and if malignancy occurs the majority of men with the disease are regarded as living with a chronic condition due to its long natural history and in which innovative approaches, interventions, treatments or changes in management might have a significant patient benefit and impact on the NHS. It therefore fits the cmRCT design very well. Nonetheless, the lessons learned in this study will be of relevance to other disease spaces.

The TWICS or cmRCT design is currently being used in elderly patients, risk of falls, depression, hip fracture, Yorkshire Health Study, scleroderma, breast cancer, colorectal cancer, bladder cancer and kidney cancer, to name a few. In total, a recent systematic review showed that there were 18 ongoing cmRCT studies with 6 in the UK.

The acceptability and feasibility of the cmRCT in the prostate pathway will be tested. This is the first time this method will be tested and therefore piloted. In the first part of the study, the following will be evaluated. What is the accrual rate? What do patients and their healthcare professionals think of the cmRCT design? Is the data collected robust? What are the resource requirements of such a study?A number of novel interventions or changes in the pathway will then be tested and compared to standard care in the cohort that was recruited.


Condition or disease
Prostate Cancer Non-metastatic Prostate Cancer Metastatic Prostate Cancer Prostate Adenocarcinoma Metastatic Prostate Carcinoma in the Soft Tissue Prostate Cancer Metastatic

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: PROState Pathway Embedded Comparative Trial
Actual Study Start Date : September 8, 2020
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 1.1a Acceptability - Rate of consent to inclusion [ Time Frame: 6 months ]
    Rate of consent to inclusion to PROSPECT cohort at the original point of contact by the research team. This will be calculated on an ongoing basis and will be reviewed at 6 months and one year from opening and at the end of the study period

  2. 1.1a Acceptability - Rate of consent to inclusion [ Time Frame: 1 year ]
    Rate of consent to inclusion to PROSPECT cohort at the original point of contact by the research team. This will be calculated on an ongoing basis and will be reviewed at 6 months and one year from opening and at the end of the study period

  3. 1.1b Acceptability - Experiences and perspectives of patients [ Time Frame: 22 months ]

    To investigate by interview the experiences and perspectives of patients who:

    • Consented to inclusion in the cohort study,
    • Declined to enter into the cohort,
    • Consented to inclusion in the cohort initially but who subsequently requested to leave the cohort,

    Structured thematic interviews will be conducted by the researchers who will follow the Interview Questionnaire Template. The interviews will be recorded and transcribed in house before analysis and theme-based extraction of the reasons behind men's decision regarding inclusion in the cohort. Recruitment for qualitative interviews will continue until no further themes emerge.


  4. 1.1e Acceptability - Opinions of healthcare professionals [ Time Frame: 6 months ]
    The opinions of healthcare professionals who regularly look after men with prostate problems will be sought through semi-structured interviews that focus on implementation, practicality and efficiency of PROSPECT. There will be a different Interview Questionnaire Template for interviews with healthcare professionals.

  5. 1.1e Acceptability - Opinions of healthcare professionals [ Time Frame: 12 months ]
    The opinions of healthcare professionals who regularly look after men with prostate problems will be sought through semi-structured interviews that focus on implementation, practicality and efficiency of PROSPECT. There will be a different Interview Questionnaire Template for interviews with healthcare professionals.

  6. 2.1a Feasibility - Participants approached vs referral [ Time Frame: 22 months ]
    Evaluation of the number of men approached to enter PROSPECT against the number of men referred to the participating centres for investigation of prostate cancer.

  7. 2.1b Feasibility - Review of the pathway by which PROSPECT approach men to invite them to the cohort. [ Time Frame: 22 months ]
    PROSPECT will conduct a review of the pathway by which they approach men to invite them to the cohort. Part of this will be included in the qualitative interviews with men and healthcare professionals. Particular points of interest will be the timing of consent process, the trial personnel who gain consent, and the number of men who give consent who are subsequently not diagnosed with prostate cancer.

  8. 2.1c Feasibility - Quality of Life [ Time Frame: 6 months ]
    Participants will be given a standard Quality of Life Questionnaire (EQ5D-5L) at the point at which they consent to inclusion into PROSPECT. Data completeness will be calculated at 6 months after opening and on an ongoing basis as long as the study is open.

  9. 2.1c Feasibility - Quality of Life [ Time Frame: 12 months ]
    Participants will be given a standard Quality of Life Questionnaire (EQ5D-5L) at the point at which they consent to inclusion into PROSPECT. Data completeness will be calculated at 12 months after opening and on an ongoing basis as long as the study is open.

  10. 2.1d Feasibility Outcome - Disease specific Quality of Life [ Time Frame: Recruitment to cohort ]

    All participants will be asked to complete questionnaires on disease specific quality of life at the following points;

    • Recruitment to cohort.
    • 0-6, 6, 12, 18, 24 months from recruitment to cohort
    • Yearly questionnaires thereafter during inclusion in the cohort if trial remains open (i.e., post pilot phase).

    PROSPECT will use three self-reporting quality of life validated questionnaires. The responses from the questionnaires will be of value as they will provide an informative vignette of the experience of men after the diagnosis of prostate cancer and they can be compared against the experience of men who are investigated for but not diagnosed with prostate cancer. In terms of evaluating the feasibility of the cmRCT design, PROSPECT will calculate the rates of response from participants with these questionnaires. Questionnaire response rates will also inform PROSPECT of the understanding of the acceptability of the cmRCT design study to patients.


  11. 2.1d Feasibility Outcome - Disease specific Quality of Life [ Time Frame: 0-6 months from recruitment to cohort ]

    All participants will be asked to complete questionnaires on disease specific quality of life at the following points;

    • Recruitment to cohort.
    • 0-6, 6, 12, 18, 24 months from recruitment to cohort
    • Yearly questionnaires thereafter during inclusion in the cohort if trial remains open (i.e., post pilot phase).

    PROSPECT will use three self-reporting quality of life validated questionnaires. The responses from the questionnaires will be of value as they will provide an informative vignette of the experience of men after the diagnosis of prostate cancer and they can be compared against the experience of men who are investigated for but not diagnosed with prostate cancer. In terms of evaluating the feasibility of the cmRCT design, PROSPECT will calculate the rates of response from participants with these questionnaires. Questionnaire response rates will also inform PROSPECT of the understanding of the acceptability of the cmRCT design study to patients.


  12. 2.1d Feasibility Outcome - Disease specific Quality of Life [ Time Frame: 6 months from recruitment to cohort ]

    All participants will be asked to complete questionnaires on disease specific quality of life at the following points;

    • Recruitment to cohort.
    • 0-6, 6, 12, 18, 24 months from recruitment to cohort
    • Yearly questionnaires thereafter during inclusion in the cohort if trial remains open (i.e., post pilot phase).

    PROSPECT will use three self-reporting quality of life validated questionnaires. The responses from the questionnaires will be of value as they will provide an informative vignette of the experience of men after the diagnosis of prostate cancer and they can be compared against the experience of men who are investigated for but not diagnosed with prostate cancer. In terms of evaluating the feasibility of the cmRCT design, PROSPECT will calculate the rates of response from participants with these questionnaires. Questionnaire response rates will also inform PROSPECT of the understanding of the acceptability of the cmRCT design study to patients.


  13. 2.1d Feasibility Outcome - Disease specific Quality of Life [ Time Frame: 12 months from recruitment to cohort ]

    All participants will be asked to complete questionnaires on disease specific quality of life at the following points;

    • Recruitment to cohort.
    • 0-6, 6, 12, 18, 24 months from recruitment to cohort
    • Yearly questionnaires thereafter during inclusion in the cohort if trial remains open (i.e., post pilot phase).

    PROSPECT will use three self-reporting quality of life validated questionnaires. The responses from the questionnaires will be of value as they will provide an informative vignette of the experience of men after the diagnosis of prostate cancer and they can be compared against the experience of men who are investigated for but not diagnosed with prostate cancer. In terms of evaluating the feasibility of the cmRCT design, PROSPECT will calculate the rates of response from participants with these questionnaires. Questionnaire response rates will also inform PROSPECT of the understanding of the acceptability of the cmRCT design study to patients.


  14. 2.1d Feasibility Outcome - Disease specific Quality of Life [ Time Frame: 18 months from recruitment to cohort ]

    All participants will be asked to complete questionnaires on disease specific quality of life at the following points;

    • Recruitment to cohort.
    • 0-6, 6, 12, 18, 24 months from recruitment to cohort
    • Yearly questionnaires thereafter during inclusion in the cohort if trial remains open (i.e., post pilot phase).

    PROSPECT will use three self-reporting quality of life validated questionnaires. The responses from the questionnaires will be of value as they will provide an informative vignette of the experience of men after the diagnosis of prostate cancer and they can be compared against the experience of men who are investigated for but not diagnosed with prostate cancer. In terms of evaluating the feasibility of the cmRCT design, PROSPECT will calculate the rates of response from participants with these questionnaires. Questionnaire response rates will also inform PROSPECT of the understanding of the acceptability of the cmRCT design study to patients.


  15. 2.1d Feasibility Outcome - Disease specific Quality of Life [ Time Frame: 24 months from recruitment to cohort ]

    All participants will be asked to complete questionnaires on disease specific quality of life at the following points;

    • Recruitment to cohort.
    • 0-6, 6, 12, 18, 24 months from recruitment to cohort
    • Yearly questionnaires thereafter during inclusion in the cohort if trial remains open (i.e., post pilot phase).

    PROSPECT will use three self-reporting quality of life validated questionnaires. The responses from the questionnaires will be of value as they will provide an informative vignette of the experience of men after the diagnosis of prostate cancer and they can be compared against the experience of men who are investigated for but not diagnosed with prostate cancer. In terms of evaluating the feasibility of the cmRCT design, PROSPECT will calculate the rates of response from participants with these questionnaires. Questionnaire response rates will also inform PROSPECT of the understanding of the acceptability of the cmRCT design study to patients.


  16. 2.1e Feasibility - Data collection [ Time Frame: 24 months after opening PROSPECT and yearly thereafter in order to monitor any trends ]
    Feasibility of collecting data from the participating centres evidenced by the completeness of data for cohort participants including; i. Subject Data: age, co-morbidities, ECOG/WHO Performance Status, ethnic risk, family risk ii. Disease Characteristics: PSA, MRI (volume, score), biopsy findings (cancer or not, grade if cancer, length of maximum cancer, other pathology), TNM stage if cancer iii. Treatment Data: modality, follow-up, adjuvant and salvage treatments, mortality Analysis will be conducted at one year after opening the PROSPECT and yearly thereafter in order to monitor any trends in improving or faltering data accrual on participants, as long as the study is open.


Secondary Outcome Measures :
  1. Qualitative Outcome Measure 1- Trial Participants [ Time Frame: 22 months ]

    The integrated qualitative component will explore patients who;

    • Consented to inclusion in the cohort study,
    • Declined to enter into the cohort,
    • Consented to inclusion in the cohort initially but who subsequently requested to leave the cohort

    Structured thematic interviews will be conducted by the researchers who will follow the Interview Questionnaire Template. The interviews will be recorded and transcribed in house before analysis and theme-based extraction of the reasons behind men's


  2. Qualitative Outcome Measure 2 - Healthcare participants [ Time Frame: 6 months ]
    The opinions of healthcare professionals who regularly look after men with prostate cancer will be sought through conducting semi-structured interviews that focus on ethics, implementation, practicality and efficiency of PROSPECT. There will be a different Interview Questionnaire Template for interviews with healthcare professionals.

  3. Qualitative Outcome Measure 2 - Healthcare participants [ Time Frame: 12 months ]
    The opinions of healthcare professionals who regularly look after men with prostate cancer will be sought through conducting semi-structured interviews that focus on ethics, implementation, practicality and efficiency of PROSPECT. There will be a different Interview Questionnaire Template for interviews with healthcare professionals.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Men with possible prostate malignancy
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All men referred for investigation of prostate cancer
Criteria

Inclusion Criteria:

  1. Men aged 18 years old and over who are referred for investigations for urinary symptoms or elevated serum prostate specific antigen (PSA) levels or other risk factors for possible prostate malignancy.
  2. An understanding of the English language sufficient to understand written and verbal information about the trial and consent process.
  3. Estimated life expectancy of 5 years or more.
  4. Signed informed consent.

Exclusion Criteria:

1. Men who are unable to give informed consent.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04400656


Contacts
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Contact: Hashim Ahmed 0203 311 1673 hashim.ahmed@imperial.ac.uk
Contact: Thiagarajah Sasikaran 0207 594 6017 t.sasikaran@imperial.ac.uk

Locations
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United Kingdom
West Middlesex University Hospital Recruiting
Isleworth, Middlesex, United Kingdom, TW7 6AF
Contact: Mathias Winkler       mathias.winkler@nhs.net   
Principal Investigator: Mathias Winkler         
Ashford & St Peter's Hospitals (ASPH) NHS Foundation Trust Recruiting
Chertsey, Surrey, United Kingdom, KT16 0PZ
Contact: Nimalan Arumainayagam       nimalan.arumainayagam@nhs.net   
Principal Investigator: Nimalan Arumainayagam         
Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom, W6 8RF
Contact: Hashim U Ahmed       hashim.ahmed@imperial.ac.uk   
Principal Investigator: Hasim U Ahmed         
Sponsors and Collaborators
Imperial College London
Imperial Clinical Trials Unit (ICTU)
Wellcome Trust
Investigators
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Principal Investigator: Hashim Ahmed Imperial College London
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT04400656    
Other Study ID Numbers: 19CX5601
First Posted: May 22, 2020    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
prostate cancer
Non-metastatic Prostate Cancer
Metastatic Prostate Cancer
Prostate Adenocarcinoma
Metastatic Prostate Carcinoma in the Soft Tissue
Prostate Cancer Metastatic
Clinical Trial Design
cohort multiple randomised controlled trial
cmRCT
Trials Within Cohorts
TWICS
Additional relevant MeSH terms:
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Prostatic Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases