Approaches to long-term active surveillance of patients with prostate cancer (IP9 – ATLAS)

Not Applicable

• Conditions: Prostate cancer; Cancer

• Registration Number: ISRCTN11447662
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-07
• Last Update Posted: 12 August 2024
• Study Completion: 2032-06-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: Male
• Target Recruitment: 1263

Inclusion Criteria

1. Age 18 years or above (no upper limit)
2. Patients with a prostate (either cis-male gender or trans-female gender with no prior androgen deprivation hormone use at all)
3. Diagnostic bi-parametric or multiparametric MRI
4. Diagnostic systematic biopsy +/- targeted biopsy
5. A histological diagnosis of localised prostate cancer of low or intermediate risk

Exclusion Criteria

1. On active surveillance for greater than 9 months prior to the screening date
2. Contraindication to MRI or gadolinium contrast
3. Previous hip replacement to both hips
4. Contraindication to performing a biopsy guided by a transrectal ultrasound probe

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression in each group, defined as higher risk cancer on biopsy (Grade Group >/=3) or higher stage (>/=T3 or >/=N or >/=M1) over 5 years. Prostate cancer progression rates and time to progression in each randomised arm defined as:<br>1. Biopsy: grade progression to Grade Group 3 or greater or detection on biopsy of intraductal cancer or lymphovascular invasion. Many clinicians would include patients on active surveillance with a cribriform pattern on Grade Group so this is not a factor for progression.<br>2. Staging: cancer has spread to surrounding tissues (extracapsular), lymph node involvement or distant body parts as demonstrated on cross-sectional imaging including MRI, CT, bone scan or PET scans as deemed appropriate by the local multidisciplinary cancer team.