Prostate CancerINTEVOPROSTATENCT03382522
Prognostic Value of SPECT-CT Quantitative Indices for the Response Assessment of Bone Metastatic Prostate Carcinoma
An observational study of Prostate Cancer, run by University Hospital, Brest at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2018to 30 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Bone metastatic prostate cancer Quantitative bone SPECT-CT available
Who may be able to join
- 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.
Who cannot join
- Opposition of the patient. Age<18 y/o
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Prostate Cancer
- Keywords
- bone scintigraphy, quantification, prostate cancer, prognosis
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic interest of the quantitative therapeutic evaluation with bone SPECT-CT in bone metastatic prostate cancer
Assessment of prognostic quantitative SPECT-CT parameters
Measured: 3 years
Secondary outcomes (4)
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)
Measured: 3 years
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)
Measured: 3 years
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)
Measured: 3 years
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)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start1 Jan 2018
- Primary completion30 Mar 2018
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382522
- Sponsor's protocol ID
- INTEVO-PROSTATE (29BRC17.0189)
- Acronym
- INTEVOPROSTATE
- Status last verified
- Nov 2017
- First submitted
- 19 Dec 2017
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of SPECT-CT Quantitative Indices for the Response Assessment of Bone Metastatic Prostate Carcinoma
- ClinicalTrials.gov ID
- NCT03382522
- Acronym / sponsor ID
- INTEVOPROSTATE / INTEVO-PROSTATE (29BRC17.0189)
- Conditions
- Prostate Cancer
- Keywords
- bone scintigraphy, quantification, prostate cancer, prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 26 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Bone metastatic prostate cancer Quantitative bone SPECT-CT available
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Opposition of the patient. Age<18 y/o
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
Correlation between baseline quantitative bone SPECT-CT values and baseline PSA
Time frame: 3 years
Correlation between baseline quantitative bone SPECT-CT values and survival
Time frame: 3 years
Correlation between variations of quantitative bone SPECT-CT values and variations of PSA
Time frame: 3 years
Correlation between variations of quantitative bone SPECT-CT values and survival
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognostic interest of the quantitative therapeutic evaluation with bone SPECT-CT in bone metastatic prostate cancer (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2018.