Improving Diagnosis and Treatment of Metastatic Advanced Prostate Cancer

Advanced Prostate Carcinoma Clinical Trial

— IDT  

Official title:

Improving Diagnosis and Treatment of Metastatic Advanced Prostate Cancer Through Better Imaging With Whole-Body Magnetic Resonance Imaging With Diffusion Weighted Imaging

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04984395
• Other study ID #: CCR5459
• Status: Not yet recruiting
• Start date: July 30, 2021
• Est. completion date: May 31, 2024

Study information

• Verified date: May 2021
• Source: Royal Marsden NHS Foundation Trust
• Contact: Ana Ribeiro
• Phone: 02089156499
• Email: ana.ribeiro[@]rmh.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Advanced Prostate Carcinoma
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• Post-treatment CT-guided bone marrow biopsy
At post-treatment, 12 +/- 3 weeks after initiating treatment, patients will undergo a CT guided bone marrow biopsy of the same lesion as baseline.

Locations

Country	Name	City	State
United Kingdom	The Royal Marsden NHS Foundation Trust	Sutton	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retrospective analysis: WBMRI parameters	Prognostic association of derived pre-treatment WBMRI parameters, total disease volume (tDV) and apparent diffusion coefficient (ADC) for prediction of overall survival.	Month 1-26
Primary	Retrospective analysis: Diagnostic performance of MET-RADS-P	Accuracy of MET-RADS-P to assess response to systemic treatment.	Month 1-26
Primary	Single centre prospective observational imaging study	Pairwise correlations of percentage of ADC change with: Tumour regression grading according to the international system of Salzer-Kuntschnik; Changes in biopsy tumour content and tumour/necrosis ratio; Fat fraction percentage with bone marrow adipose tissue/fibrosis reported by histopathology analysis.	Month 6-38
Secondary	Retrospective analysis: WBMRI parameters	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).	Month 1-26
Secondary	Retrospective analysis: Diagnostic performance of MET-RADS-P	Inter-observer agreement - determine prognostic association of MET-RADS-P response for prediction of overall survival.	Month 1-26
Secondary	Single centre prospective observational imaging study	Fraction of bone biopsies with sufficient tumour yield for genomic sequencing.	Month 6-38