Effect of Apalutamide on Metastatic Hormone-Sensitive Prostate Cancer

Impact of Apalutamide in Metastatic Hormone Sensitive Prostate Cancer Patients, a Multicentre Prospective Observational Study

This study is testing how well apalutamide works for men with metastatic hormone-sensitive prostate cancer and how it affects their quality of life, energy levels, and thinking over two years.

Quick facts

• Study type: Observational
• Enrollment: 170 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Royal Marsden NHS Foundation Trust (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 12 sites (Sutton, Surrey and 11 other locations)
• Trial ID: NCT06019676 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the impact of apalutamide in patients with metastatic hormone-sensitive prostate cancer (mHSPC) who have chosen this treatment as part of their management plan. The study aims to document the biochemical effectiveness of apalutamide through monitoring Prostate-Specific Antigen (PSA) levels and assess its effects on health-related quality of life, fatigue, and cognitive function using patient-reported outcome questionnaires. Patients will complete these questionnaires at specified intervals over a period of two years to gather comprehensive data on their experiences and outcomes.

Who should consider this trial

Good fit: Ideal candidates include males aged 18 and older with a confirmed diagnosis of metastatic hormone-sensitive prostate cancer who are considering apalutamide as part of their treatment.

Not a fit: Patients with non-metastatic prostate cancer or those who have previously received certain prostate cancer treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness of apalutamide and improve quality of life for patients with mHSPC.

How similar studies have performed: Other studies have shown promising results with apalutamide in similar patient populations, indicating a potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Male 18 years of age or older
* Histologically confirmed diagnosis of adenocarcinoma of the prostate with both:
* Metastatic hormone sensitive prostate cancer
* Treatment decision for apalutamide by clinician

Exclusion Criteria:

* Non-metastatic prostate cancer
* Prior chemotherapy / abiraterone / apalutamide / darolutamide / enzalutamide for prostate cancer
* Unable to complete patient reported outcome questionnaires

Where this trial is running

Sutton, Surrey and 11 other locations

• The Royal Marsden Hospital — Sutton, Surrey, United Kingdom (Recruiting)
• Buckinghamshire Healthcare NHS Trust — Aylesbury, United Kingdom (Recruiting)
• Northern Ireland Cancer Centre, Belfast Health & Social Care Trust — Belfast, United Kingdom (Not_yet_recruiting)
• East Lancashire Hospitals NHS Trust — Blackburn, United Kingdom (Recruiting)
• Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust — Cambridge, United Kingdom (Recruiting)
• Velindre Cancer Centre, Velindre University NHS Trust — Cardiff, United Kingdom (Not_yet_recruiting)
• University Hospitals of Morecambe Bay NHS Foundation Trust — Lancaster, United Kingdom (Recruiting)
• Clatterbrdige Cancer Centre, NHS Foundation Trust — Liverpool, United Kingdom (Recruiting)
• The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust — Middlesbrough, United Kingdom (Recruiting)
• South Tyneside and Sunderland NHS Foundation Trust — Newcastle, United Kingdom (Recruiting)
• Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust — Newcastle, United Kingdom (Recruiting)
• The University Hospital of North Tees — Stockton-on-Tees, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Julia Murray, Dr. — The Royal Marsden Hospital, NHS Foundation Trust
• Study coordinator: Greta Bucinskaite

Conditions Metastatic Hormone-Sensitive Prostate Cancer