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

Prostate Cancer Clinical Trial

— INTEVOPROSTATE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03382522
• Other study ID #: INTEVO-PROSTATE (29BRC17.0189)
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: March 30, 2018

Study information

• Verified date: November 2017
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: March 30, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prognostic interest of the quantitative therapeutic evaluation with bone SPECT-CT in bone metastatic prostate cancer	Assessment of prognostic quantitative SPECT-CT parameters	3 years
Secondary	Correlation between baseline quantitative bone SPECT-CT values and baseline PSA	Assessment of correlation between baseline PSA and baseline quantitative SPECT-CT parameters (SUVmax (max Standardized Uptake Value) of the target lesions, SUVpeak of the highest uptake lesion, Neoplastic Osteoblastic Metabolism Volume, Total Lesion Osteoblastic Metabolism) (Spearman coefficient)	3 years
Secondary	Correlation between baseline quantitative bone SPECT-CT values and survival	Assessment of correlation between survival (Progression Free Survival, Overall Survival, Disease Specific Survival) and baseline quantitative SPECT-CT parameters (SUVmax of the target lesions, SUVpeak of the highest uptake lesion, Neoplastic Osteoblastic Metabolism Volume, Total Lesion Osteoblastic Metabolism)	3 years
Secondary	Correlation between variations of quantitative bone SPECT-CT values and variations of PSA	Assessment of correlation between variations of PSA and variations of quantitative SPECT-CT parameters (SUVmax of the target lesions, SUVpeak of the highest uptake lesion, Neoplastic Osteoblastic Metabolism Volume, Total Lesion Osteoblastic Metabolism) (Spearman coefficient)	3 years
Secondary	Correlation between variations of quantitative bone SPECT-CT values and survival	Assessment of correlation between survival (Progression Free Survival, Overall Survival, Disease Specific Survival) and variations of quantitative SPECT-CT parameters (SUVmax of the target lesions, SUVpeak of the highest uptake lesion, Neoplastic Osteoblastic Metabolism Volume, Total Lesion Osteoblastic Metabolism)	3 years