NCT03382522

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 26, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2018

Completed
Last Updated

July 23, 2018

Status Verified

November 1, 2017

Enrollment Period

3 months

First QC Date

December 19, 2017

Last Update Submit

July 20, 2018

Conditions

Prostate Cancer

Keywords

bone scintigraphyquantificationprostate cancerprognosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Correlation between baseline quantitative bone SPECT-CT values and baseline PSA

    3 years

  • Correlation between baseline quantitative bone SPECT-CT values and survival

    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

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Bone metastatic prostate cancer Quantitative bone SPECT-CT available

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2017

First Posted

December 26, 2017

Study Start

January 1, 2018

Primary Completion

March 30, 2018

Study Completion

March 30, 2018

Last Updated

July 23, 2018

Record last verified: 2017-11

Locations

FR(1)