Ignite Creation Date:
2024-07-17 @ 10:42 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06479187
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-24
Brief Title:
PSMAtrack-tracking Changes in PSMA-PET During Initial Therapy for Metastatic Hormone-sensitive Prostate Cancer
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
PSMAtrack-tracking Changes in PSMA-PET During Initial Therapy for Metastatic Hormone-sensitive Prostate Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if serial PSMA-PETCT scans can be used to monitor response to therapy in metastatic hormone sensitive prostate cancer and can be potentially used to optimize future treatment approaches
The main questions it aims to answer are
What is the proportion of men with residual PSMA-avid disease on PETCT scans after 6 months of treatment for metastatic hormone sensitive prostate cancer Do the findings on PSMA-PETCT scans after 6 months of treatment for metastatic hormone sensitive prostate cancer correlate with other markers of disease status like PSA
Participants will
Receive standard of care treatment for metastatic hormone sensitive prostate cancer Undergo a PSMA-PETCT scan before starting treatment Undergo a PSMA-PETCT scan after 6 months of treatment Have a chart review every 3 months for 1 year after the 6 month PSMA-PETCT scan
The main questions it aims to answer are
What is the proportion of men with residual PSMA-avid disease on PETCT scans after 6 months of treatment for metastatic hormone sensitive prostate cancer Do the findings on PSMA-PETCT scans after 6 months of treatment for metastatic hormone sensitive prostate cancer correlate with other markers of disease status like PSA
Participants will
Receive standard of care treatment for metastatic hormone sensitive prostate cancer Undergo a PSMA-PETCT scan before starting treatment Undergo a PSMA-PETCT scan after 6 months of treatment Have a chart review every 3 months for 1 year after the 6 month PSMA-PETCT scan
Detailed Description:
The current approach to imaging metastatic hormone sensitive prostate cancer mHSPC is via conventional scans CTMRIbone scan but prostate specific membrane antigen PSMA-positron emission tomography PET is being increasingly used for imaging prostate cancer Given its greater diagnostic accuracy compared to conventional imaging there is a strong rationale to evaluate PSMA-PET in imaging mHSPC Moreover serial imaging with PSMA-PET may offer a better opportunity to evaluate disease response with systemic therapy and potentially use the results to guide therapy given that PSMA-targeted radioligand therapy 177Lu-PSMA-617 is now approved for metastatic castrate-resistant prostate cancer mCRPC Furthermore the 6-month timepoint after initiation of systemic therapy is an ideal time to perform interim PSMA-PET given that 6-month prostate specific antigen PSA has strong prognostic value in mHSPC in the era of intensified systemic therapy
This is a prospective trial of 18F-rhPSMA-73 PSMA-PETCT at baseline and after 6 months of therapy for mHSPC with the aim of evaluating changes in disease extent during this timeframe and correlating this with the PSA response Results from this pilot study could be used to plan trials assessing deintensification of therapy at 6 months based on PSMA-PET
The primary study objective is to determine the proportion of patients with residual PSMA-avid disease on 18F-rhPSMA-73 PSMA-PET after 6 months of therapy for mHSPC
Exploratory objectives are
To correlate presenceabsence of residual PSMA-avid disease after 6 months with PSA 02 ngmL at 6 months of therapy
To evaluate changes in SUVmax SUVmean total tumor volume and other PET imaging parameters between baseline and 6 months
To evaluate PET imaging parameters at baseline that predict for achievement of PSA 02 ngmL at 6 months
To explore use of artificial intelligence AI and machine learning ML tools in delineating tumor burden and volume on 18F-rhPSMA-73 PSMA-PET
Patients will undergo baseline 18F-rhPSMA-73 PSMA-PETCT and 18F-rhPSMA-73 PSMA-PETCT 6 months after starting treatment for mHSPC with androgen deprivation therapy and androgen receptor pathway inhibitor with or without docetaxel
Patients will be followed via chart review for 1 year after the 6 month PSMA-PETCT scan or death whichever occurs first
This is a prospective trial of 18F-rhPSMA-73 PSMA-PETCT at baseline and after 6 months of therapy for mHSPC with the aim of evaluating changes in disease extent during this timeframe and correlating this with the PSA response Results from this pilot study could be used to plan trials assessing deintensification of therapy at 6 months based on PSMA-PET
The primary study objective is to determine the proportion of patients with residual PSMA-avid disease on 18F-rhPSMA-73 PSMA-PET after 6 months of therapy for mHSPC
Exploratory objectives are
To correlate presenceabsence of residual PSMA-avid disease after 6 months with PSA 02 ngmL at 6 months of therapy
To evaluate changes in SUVmax SUVmean total tumor volume and other PET imaging parameters between baseline and 6 months
To evaluate PET imaging parameters at baseline that predict for achievement of PSA 02 ngmL at 6 months
To explore use of artificial intelligence AI and machine learning ML tools in delineating tumor burden and volume on 18F-rhPSMA-73 PSMA-PET
Patients will undergo baseline 18F-rhPSMA-73 PSMA-PETCT and 18F-rhPSMA-73 PSMA-PETCT 6 months after starting treatment for mHSPC with androgen deprivation therapy and androgen receptor pathway inhibitor with or without docetaxel
Patients will be followed via chart review for 1 year after the 6 month PSMA-PETCT scan or death whichever occurs first
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None