Ignite Creation Date:
2024-05-06 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05924672
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2023-06-20
Brief Title:
Efficacy of Ra-223 in PSMA PET Optimally Selected Patients
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Efficacy of Ra-223 in PSMA PET Optimally Selected Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
This phase II trial studies how well prostate-specific membrane antigen PSMA positron emission tomography PET scans in combination with bone scans work in selecting patients for Ra-223 radiation therapy that have castration-resistant prostate cancer that has spread from where it first started primary site to the bones bone metastasis Ra-223 is a type of therapy that emits radiation Radiation gives off energy which can kill tumor cells and other cells that may support the tumor cells Ra-223 is given by infusion into the veins where it is absorbed by the bones PSMA PET is a type of scan used to detect prostate cancer tumors PSMA is a radioactive tracer that binds to a specific protein that is found on prostate tumor cells The PSMA tracer shows the areas on the PET scan where tumor cells are active A PET scan uses a special camera to detect the energy given off from radioactive tracers such as PSMA to make detailed pictures of areas where the tracer accumulates in the body The PET scan is often combined with a magnetic resonance imaging MRI or computed tomography CT scan which helps to map the locations where PSMA has accumulated PSMA PET scans may be able to select patients that will benefit the most from Ra-223 treatment
Detailed Description:
PRIMARY OBJECTIVE
I To determine the PSA50 response rate of participants treated with radium Ra 223 dichloride Ra-223
SECONDARY OBJECTIVES
I To determine the median overall survival mOS of participants treated with Ra-223
II To determine the PSA30 response rate of partoicipants treated with Ra-223 III To determine the time to the first skeletal symptomatic event IV To characterize the safety profile of Ra-223 treatment V To compare the lesion based PSMA PET response based on sodium fluoride NaF PETtechnetium Tc-99m medronate MDP single photon emission computed tomography SPECT uptake
EXPLORATORY OBJECTIVES I To compare the PSA response stratified by PSMA PET tumor volume II To determine the location of progression by location III Safety on subsequent treatment with PSMA radioligand therapy RLT
OUTLINE
Participants undergo NaF PETCT or MDP scan within 45 days prior to standard of care SOC Ra-223 intravenously IV Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity Participants then undergo a PSMA PETCT between 30-60 days after the last dose of Ra-223 Participants also undergo collection of blood samples during screening on the first day of every Ra-223 cycle and at 30 days after the last dose Participants may also undergo a NaF PETCT or MDP scan during treatment as clinically indicated andor CT scans during screening and treatment as clinically indicated
After completion of Ra-223 treatment participants are followed up at 30 days and then every 3-6 months
I To determine the PSA50 response rate of participants treated with radium Ra 223 dichloride Ra-223
SECONDARY OBJECTIVES
I To determine the median overall survival mOS of participants treated with Ra-223
II To determine the PSA30 response rate of partoicipants treated with Ra-223 III To determine the time to the first skeletal symptomatic event IV To characterize the safety profile of Ra-223 treatment V To compare the lesion based PSMA PET response based on sodium fluoride NaF PETtechnetium Tc-99m medronate MDP single photon emission computed tomography SPECT uptake
EXPLORATORY OBJECTIVES I To compare the PSA response stratified by PSMA PET tumor volume II To determine the location of progression by location III Safety on subsequent treatment with PSMA radioligand therapy RLT
OUTLINE
Participants undergo NaF PETCT or MDP scan within 45 days prior to standard of care SOC Ra-223 intravenously IV Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity Participants then undergo a PSMA PETCT between 30-60 days after the last dose of Ra-223 Participants also undergo collection of blood samples during screening on the first day of every Ra-223 cycle and at 30 days after the last dose Participants may also undergo a NaF PETCT or MDP scan during treatment as clinically indicated andor CT scans during screening and treatment as clinically indicated
After completion of Ra-223 treatment participants are followed up at 30 days and then every 3-6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-04656 | REGISTRY | NCI Clinical Trials Reporting Program CTRP | None |