Clinical trial NCT04984395: Improving Diagnosis and Treatment of Metastatic Advanced Prostate Cancer
Official title: Improving Diagnosis and Treatment of Metastatic Advanced Prostate Cancer Through Better Imaging With Whole-Body Magnetic Resonance Imaging With Diffusion Weighted Imaging
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Advanced Prostate Carcinoma
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with metastatic, advanced prostate cancer.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Retrospective analysis: WBMRI parameters
timeFrame: Month 1-26
measure: Retrospective analysis: Diagnostic performance of MET-RADS-P
timeFrame: Month 1-26
measure: Single centre prospective observational imaging study
timeFrame: Month 6-38
Secondary outcomes:
measure: Retrospective analysis: WBMRI parameters
timeFrame: Month 1-26
measure: Retrospective analysis: Diagnostic performance of MET-RADS-P
timeFrame: Month 1-26
measure: Single centre prospective observational imaging study
timeFrame: Month 6-38
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
state: Surrey
Study officials:
affiliation: The Royal Marsden NHS FT
name: Nina Tunariu
role: PRINCIPAL_INVESTIGATOR
References: