Response Evaluation of Cancer Therapeutics in Metastatic Castration-Resistant Prostate Cancer to the Bone

NCT ID: NCT06321679

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-03
• Study Completion Date: 2027-12-31

Brief Summary

This study is aimed to compare whole body MRI (WB-MRI) with Bone Scintigraphy (BS) and Computerized Tomography (CT) scans in patients receiving treatment for metastatic castration-resistant prostate cancer to the bone.

This is a monocentric, prospective observational study.

Detailed Description

This is an observational study and will not influence the choice of treatment. The treating clinicians will be able to use any clinical treatment regimen that is considered appropriated for the patient. This may include hormonal therapy or chemotherapy or therapy with radium-223. In addition, patients may be treated with bisphosphonates/denosumab, and granulocity-colony stimulating factor. The duration of therapy, doses, schedules, timing, premedication, patient monitoring during treatment, dose adjustments, and duration of therapy are entirely at the discretion of the treating clinician.

The use of radiotherapy is permitted, but the details including fields used must be communicated to the reporting radiologist to ensure this does not affect the interpretation of imaging. All other supportive or palliative treatments are permitted.

All patients will undergo imaging assessments as follows:

• At baseline, CT, BS (99mTc-MDP) and Whole Body-Magnetic Resonance Imaging (WB-MRI) will be performed.
• Follow-up imaging will be CT, BS and WB-MRI performed every 12 weeks until week 96, and then every 24 weeks until disease progression occurs or week 192.

Additional patient assessments to be performed include:

• questionnaires at baseline, week 36 and end of study to evaluate patient perception, acceptance and preferences regarding the imaging modalities.
• clinical and physical examinations according to routine clinical practice. The radiologist reporting the WB-MRI will be blinded to the results of the CT and BS.

The radiologist reporting the CT and the nuclear medicine physician reporting the BS will likewise be blinded to the results of the WB-MRI.

Neither treating clinicians nor patients will be blinded at any point.

Conditions

Castration-resistant Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

WB-MRI

Each patient will undergo imaging with CT, BS and WB-MRI at each study timepoint

Imaging evaluation

Intervention Type: PROCEDURE

each patient will undergo imaging with CT, BS and WB-MRI at each study timepoint

Interventions

Imaging evaluation

each patient will undergo imaging with CT, BS and WB-MRI at each study timepoint

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Histological diagnosis of castration-resistant prostate cancer,
• Single or multiple bone metastases,
• Life expectancy of over 6 months,
• No current active malignancy other than prostate cancer,
• Provision of written informed consent.

Exclusion Criteria

• Absolute contraindication to WB-MRI, CT or BS,
• Radical treatment of sole site of metastatic disease (e.g. Cyberknife to solitary metastatic lesion),
• Psychological, familial, sociological or geographical conditions that would hamper compliance with the study protocol; such conditions are to be discussed with the patient as part of the informed consent process.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

European Institute of Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giuseppe Petralia

Role: PRINCIPAL_INVESTIGATOR

European Institute of Oncology

Locations

IEO Istituto Europeo di Oncologia

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Giuseppe Petralia, MD

Role: CONTACT

giuseppe.petralia@ieo.it

+39 02 9437 2901

Facility Contacts

Giuseppe Petralia

Role: primary

giuseppe.petralia@ieo.it

Other Identifiers

IEO 1269

Identifier Type: -

Identifier Source: org_study_id