NCT04647474

Brief Summary

The complex relationship that exists between physical and mental health in prostate cancer is increasingly being understood. Psychiatric symptoms are common in this group and have important consequences for the quality of life and cancer outcomes for patients with prostate cancer. However, less is understood about the severity of disease and which patient factors and treatment options are risk factors for developing problems. Additionally, the impact these conditions have on problems such as urinary incontinence or sexual function is less well understood. The investigators anticipate that different patient characteristics and treatment options increase an individuals risk of developing problems after a prostate cancer diagnosis. Therefore, this study aims to further investigate these specific factors to improve follow up care in patients with prostate cancer. This observational study will follow up newly diagnosed prostate cancer patients for a period of 12 months to evaluate these outcomes. Participants will be identified across seven hospitals in London and South England. After being recruited participants will be invited to undergo repeated online or postal questionnaires at baseline, 3, 6, 9 and 12 months. These will assess depressive and anxiety symptom load, body image issues, fear of recurrence, masculinity perception and functional symptoms (including urinary, bowel and sexual symptoms) load. Analysis of these findings will allow for identification of 1) Which subgroups of patients appear to have worse mental wellbeing and quality of life outcomes, and 2) How mental health issues impact functional outcomes. This will provide important information for guiding future research within the subject area and further inform clinicians about these issues.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 1, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

January 15, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2023

Completed
Last Updated

May 26, 2023

Status Verified

May 1, 2023

Enrollment Period

2.2 years

First QC Date

November 23, 2020

Last Update Submit

May 24, 2023

Conditions

Prostate Cancer

Keywords

Prostate CancerDepressionAnxietyMental WellbeingFunctional OutcomesSocial Wellbeing

Outcome Measures

Primary Outcomes (1)

  • Mean difference of mental wellbeing measures between four management groups

    Mental wellbeing validated tools scores including Patient Health Questionnaire-9 (PHQ-9), Generalised Anxiety Disorder-7 (GAD-7), Body Image Scale, Fear of Recurrence Scale and Masculine Self-Esteem Prostate Cancer-Related Quality of Life (PC-QOL) Subset Scale

    Baseline, 3, 6, 9 and 12 months post diagnosis

Secondary Outcomes (4)

  • Cumulative incidence of significant mental wellbeing outcomes

    12 Months

  • Exploration of prognostic factors of mental wellbeing outcomes.

    Within 12 months of diagnosis

  • Relationship between each individual mental wellbeing symptom and functional/social wellbeing.

    At 12 months post diagnosis.

  • Evaluation of effect of time on symptoms

    Within 12 months of diagnosis

Study Arms (4)

Radical Prostatectomy

Participants undergoing any curative surgical treatment option for prostate cancer irregardless of approach (open, laparoscopic or robotic)

Active Surveillance

Participants undergoing active surveillance as the management option for prostate cancer as defined by regular surveillance attendance at the primary treating site.

Hormone Monotherapy

Participants undergoing medical hormone therapy (Antiandrogens and Gonadotropin-releasing hormone (GnRH) agonists or antagonists) or surgical castration (e.g. orchidectomy) options as the primary treatment for prostate cancer.

Radical Radiotherapy

Participants undergoing primary radiotherapy treatment for prostate cancer irregardless of delivery methods (e.g. External beam radiation therapy or brachytherapy).

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population of study are patients with a recently newly confirmed diagnosis, or clinically likely diagnosis of prostate cancer in a secondary care setting. Four separate sub-cohorts based on treatment or management allocated will be recruited with identical inclusion and exclusion criteria, with the exception of treatment specific characteristics. The four cohorts to be recruited will be newly diagnosed men with prostate are those described in the eligibility criteria.

You may qualify if:

  • New diagnosis of histologically proven or clinically likely prostate cancer
  • No limits on grade, histology type or risk stratification classification
  • Post Multi Disciplinary Team discussion with allocation of a suggested treatment or follow up strategy
  • Undergoing one of the following four treatment/management options:
  • Radical Prostatectomy
  • Radiotherapy (External beam radiation therapy or brachytherapy)
  • Active Surveillance
  • Androgen Deprivation Therapy (Medical or Surgical castration)
  • Follow up undertaken by urology, oncology or mixed uro-oncology teams

You may not qualify if:

  • Patient is pre-Multi Disciplinary Team discussion
  • Patient has already undergone the allocate intervention
  • Post-surgery
  • Post first radiotherapy dose
  • Attended second active surveillance follow up
  • Received \>1 dose (initial dose) of Gonadotropin-releasing hormone agonist/antagonist
  • Patients receiving the following therapies:
  • Palliative patients on symptom control only
  • Patients allocated to watchful waiting
  • Any type of Focal therapy e.g. high intensity focused ultrasound (HIFU)
  • Patients receiving adjuvant combination therapy e.g. Androgen deprivation therapy or chemotherapy pre radiotherapy or surgery
  • Metastatic patients undergoing chemotherapy alone
  • Patients presenting with recurrence or progression of prostate cancer
  • Concurrent management for another cancer diagnosis
  • Recent admission to an inpatient psychiatric facility within the previous 12 months prior to diagnosis of prostate cancer
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Bedfordshire Hospitals NHS Foundation Trust

Bedford, Bedfordshire, MK42 9DJ, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, Greater London, SE1 9RS, United Kingdom

Location

Lewisham and Greenwich NHS Trust

London, Greater London, SE18 4QH, United Kingdom

Location

King's College Hospital NHS Foundation Trust

London, Greater London, SE5 9RS, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, Greater London, W2 1NY, United Kingdom

Location

Medway NHS Foundation Trust

Gillingham, Kent, ME7 5NY, United Kingdom

Location

Surrey and Sussex Healthcare NHS Trust

Redhill, Surrey, RH1 5RH, United Kingdom

Location

Related Publications (2)

  • Brunckhorst O, Liszka J, James C, Fanshawe JB, Hammadeh M, Thomas R, Khan S, Sheriff M, Muir G, Ahmed HU, Van Hemelrijck M, Stewart R, Dasgupta P, Ahmed K. Mental well-being in prostate cancer: A multi-institutional prospective cohort study. BJUI Compass. 2025 Jun 17;6(6):e70040. doi: 10.1002/bco2.70040. eCollection 2025 Jun.

    PMID: 40528942DERIVED

  • Brunckhorst O, Liszka J, James C, Fanshawe JB, Hammadeh M, Thomas R, Khan S, Sheriff M, Ahmed HU, Van Hemelrijck M, Muir G, Stewart R, Dasgupta P, Ahmed K. Mental wellbeing and quality of life in prostate cancer (MIND-P): Protocol for a multi-institutional prospective cohort study. PLoS One. 2023 Apr 24;18(4):e0284727. doi: 10.1371/journal.pone.0284727. eCollection 2023.

    PMID: 37093833DERIVED

MeSH Terms

Conditions

Prostatic NeoplasmsDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesBehavioral SymptomsBehaviorMental Disorders

Study Officials

  • Kamran Ahmed, MBBS, FRCS

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2020

First Posted

December 1, 2020

Study Start

January 15, 2021

Primary Completion

March 29, 2023

Study Completion

March 29, 2023

Last Updated

May 26, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

Anonymised individual participant data pertaining to any analysis conducted by this research will be made available publicly without restriction after the conductance of the study through the King's Research Data Repository.

Shared Documents
SAP, ANALYTIC CODE
Time Frame
All raw data will be made available by the time of publication of the research study in a peer reviewed journal. This will be archived for a duration of 20 years.
Access Criteria
Openly available through the King's Research Data Repository.

Locations

GB(7)