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

Response Evaluation of Cancer Therapeutics in Metastatic Castration-Resistant Prostate Cancer (mCRPC) to the Bone: A Whole Body MRI Study

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.

Study Overview

• Status: Recruiting
• Conditions: Castration-resistant Prostate Cancer
• Intervention / Treatment: Procedure: Imaging evaluation

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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Giuseppe Petralia, MD; Phone Number: +39 02 9437 2901; Email: giuseppe.petralia@ieo.it

Study Locations

• Italy
  • Milan, Italy, 20141
    • Recruiting
    • IEO Istituto Europeo di Oncologia
    • Contact: Giuseppe Petralia; Email: giuseppe.petralia@ieo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The estimated rate of recruitment to the study 6-7 patients a month, thus it is expected that patient accrual will be completed within 7 months.

Based on recent treatment patterns, the expected distribution of treatments is:

• Hormonal treatments

  • Enzalutamide: 14 patients
  • Abiraterone: 8 patients

• Chemotherapy

  • Docetaxel: 11 patients
  • Cabazitaxel: 5 patients
• Radiopharmaceutical drug - Radium-223: 2 patients

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
WB-MRI; Each patient will undergo imaging with CT, BS and WB-MRI at each study timepoint	Procedure: Imaging evaluation; each patient will undergo imaging with CT, BS and WB-MRI at each study timepoint

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to disease progression in bone metastasis identify by WB-MRI	the proportion of WB-MRI examinations that identify disease progression in bone metastases prior to CT + BS	192 weeks

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Investigators: Principal Investigator: Giuseppe Petralia, European Institute of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: whole body magnetic resonance imaging; castration-resistant prostate cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: IEO 1269

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No