Skip to main content
Clinical Trials/NCT03382522
NCT03382522
Completed
Not Applicable

Prognostic Value of SPECT-CT Quantitative Indices for the Response Assessment of Bone Metastatic Prostate Carcinoma

University Hospital, Brest1 site in 1 country19 target enrollmentJanuary 1, 2018
ConditionsProstate Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
University Hospital, Brest
Enrollment
19
Locations
1
Primary Endpoint
Prognostic interest of the quantitative therapeutic evaluation with bone SPECT-CT in bone metastatic prostate cancer
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Prognostic interest of bone scintigraphy in bone metastatic prostate carcinoma (BMPC) has been shown. Recent technological advances allow to perform quantitative bone SPECT-CT in routine practice. The aim of this study is to assess the prognostic interest of quantitative bone SPECT-CT in BMPC.

Detailed Description

Prostate adenocarcinoma is one of the most common cancer in men, and bone its most frequent distant metastasis location. 5-year survival has greatly increased these last two decades, with wide differences between countries. Nevertheless, the prognosis of castrate-resistant bone metastatic prostate cancer (BMPC) remains poor. PCWG (Prostate Cancer Working Group) 2 has proposed in 2007 criteria to evaluate response to treatment for prostate cancer. There are based on composite data, including clinical signs (such as general condition and bone pain), Prostatic Specific Antigen (PSA) variation, CT scan (RECIST criteria) and bone scan. The scintigraphic part is based on whole body planar acquisition, and on the assessment of new uptakes. These bone scan criteria are simplistic, because only a visual analysis is possible, without consideration of changes in intensity. Moreover, these criteria consider the bone scan as a planar imaging, and it has been shown that Single Photon Emission Computed Tomography (SPECT) improved sensitivity, specificity, positive and negative predictive values in oncologic context. Finally, "PCWG2 (Prostate Cancer Working Group 2) recognizes that there are no validated criteria for response on radionuclide bone scan". To reflect bone metastasis burden, a quantitative analysis method for bone scintigraphy, the Bone Scan Index (BSI), had been tested. BSI is based on the uptake of whole body planar imaging. While baseline BSI seemed to offer a poor correlation with overall survival (OS), on-treatment changes in BSI appeared to be a decent response marker. But a volumetric quantitative biomarker may improve the accuracy of this assessment. The recent development of a new SPECT quantification tool (xSPECT Quant® tool, Siemens) could offer good performances on therapeutic assessment. The objective of this study is to assess the interest of this new quantitative volumetric method in bone scan response evaluation of BMPC.

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
March 30, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients who underwent a bone SPECT-CT (Symbia INTEVO T6) between april 2014 and april 2017, with bone metastatic prostate cancer.
  • No opposition of the patient to participate in the study.

Exclusion Criteria

  • Opposition of the patient. Age\<18 y/o

Outcomes

Primary Outcomes

Prognostic interest of the quantitative therapeutic evaluation with bone SPECT-CT in bone metastatic prostate cancer

Time Frame: 3 years

Assessment of prognostic quantitative SPECT-CT parameters

Secondary Outcomes

  • Correlation between baseline quantitative bone SPECT-CT values and survival(3 years)
  • Correlation between baseline quantitative bone SPECT-CT values and baseline PSA(3 years)
  • Correlation between variations of quantitative bone SPECT-CT values and variations of PSA(3 years)
  • Correlation between variations of quantitative bone SPECT-CT values and survival(3 years)

Study Sites (1)

Loading locations...

Similar Trials