Improving Diagnosis and Treatment of Metastatic Advanced Prostate Cancer

• Conditions: Advanced Prostate Carcinoma

• Registration Number: NCT04984395
• Lead Sponsor: Royal Marsden NHS Foundation Trust

Brief Summary

The aim of this study is to provide clinical evidence to determine if Whole Body Magnetic Resonance Imaging (WBMRI) with a novel technique called diffusion-weighted imaging (DWI) can improve current treatment for APC patients, allowing for early identification of disease progression or treatment response, hence facilitating clinical decision-making and leading to improvement in patient care. The IDT study includes two retrospective analyses and a single centre prospective observational study for APC patients.

Detailed Description

Metastatic Advanced Prostate Cancer occurs when cancer spreads from the prostate to other parts of the body (bones, lymph nodes or other organs), with bones being the commonest site of spread in prostate cancer. These cancer growths are called metastases. APC metastases are diverse (heterogeneous) in their growth pattern, such that not all metastases will respond to the same treatment.

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-07-21
• Study First Submitted QC: 2021-07-21
• Last Update Submitted: 2021-07-21
• Study Start: 2021-07-30
• Study First Posted: 2021-07-30
• Last Update Posted: 2021-07-30
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

Retrospective study A Baseline WBMRI scans in metastatic APC patients acquired up to 8 weeks prior to the initiation of a new line of therapy.

Retrospective study B Paired WBMRI scans in metastatic APC patients at baseline within 8 weeks prior to treatment and at 12 ± 3 weeks after systemic treatment

Prospective study C Written informed consent. Age ≥18 years. Advanced prostate cancer patients with indication for systemic anti-cancer therapy to be enrolled in a clinical study.

Participants must have a baseline WBMRI and CT-guided bone marrow biopsy.

Exclusion Criteria

Prospective Study C Patient is claustrophobic. Contraindications to MRI examination (e.g., cardiac pacemakers, cochlear implants).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Retrospective analysis: Diagnostic performance of MET-RADS-P	Month 1-26	Accuracy of MET-RADS-P to assess response to systemic treatment.
Single centre prospective observational imaging study	Month 6-38	Pairwise correlations of percentage of ADC change with: 1. Tumour regression grading according to the international system of Salzer-Kuntschnik; 2. Changes in biopsy tumour content and tumour/necrosis ratio; 3. Fat fraction percentage with bone marrow adipose tissue/fibrosis reported by histopathology analysis.
Retrospective analysis: WBMRI parameters	Month 1-26	Prognostic association of derived pre-treatment WBMRI parameters, total disease volume (tDV) and apparent diffusion coefficient (ADC) for prediction of overall survival.

Secondary Outcome Measures

Name	Time	Method
Retrospective analysis: WBMRI parameters	Month 1-26	Prognostic association of baseline tDV and ADC for prediction of radiographic Progression Free Survival (rPFS) using Prostate Cancer Working Group 3 criteria (PCWG3) and Skeletal Related Events (SREs).
Retrospective analysis: Diagnostic performance of MET-RADS-P	Month 1-26	Inter-observer agreement - determine prognostic association of MET-RADS-P response for prediction of overall survival.
Single centre prospective observational imaging study	Month 6-38	Fraction of bone biopsies with sufficient tumour yield for genomic sequencing.

Trial Locations

Locations (1)

The Royal Marsden NHS Foundation Trust; 🇬🇧 Sutton, Surrey, United Kingdom