Clinical trial · Observational
Mental Wellbeing and Quality of Life in Prostate Cancer
A Prospective and Longitudinal Cohort Study Assessing Mental wellbeIng and Quality of Life in Prostate Cancer - the MIND-P Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (4)
- label
- Radical Prostatectomy
- description
- Participants undergoing any curative surgical treatment option for prostate cancer irregardless of approach (open, laparoscopic or robotic)
- label
- Active Surveillance
- description
- Participants undergoing active surveillance as the management option for prostate cancer as defined by regular surveillance attendance at the primary treating site.
- label
- Hormone Monotherapy
- description
- 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.
- label
- Radical Radiotherapy
- description
- Participants undergoing primary radiotherapy treatment for prostate cancer irregardless of delivery methods (e.g. External beam radiation therapy or brachytherapy).
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Patients lacking capacity to consent or undertake in the research * Those unable to complete the required surveys, such as those not able to understand English or those with severe learning disability
References
Publications (2)
- DERIVEDBrunckhorst 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 40528942
- DERIVEDBrunckhorst 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 37093833