This phase II trial evaluates whether mid-treatment imaging with 18F-flotufolastat positron emission tomography (PET)/computed tomography (CT) is useful for guiding stereotactic body radiation therapy (SBRT) after initiation of hormone therapy in patients with prostate cancer. Prostate cancer is commonly treated with a combination of hormone therapy and radiation therapy. Hormone therapy lowers testosterone levels and often shrinks or weakens prostate cancer before radiation begins. However, after hormone therapy starts, it can become harder for doctors to tell exactly where active cancer remains inside the prostate using standard imaging. A PET scan is a procedure in which a small amount of radioactive tracer (in the case of this research, 18F-flotufolastat) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the tracer is taken up. Because prostate tumor cells often take up more tracer than normal cells, the pictures can be used to find tumor cells in the body. A CT scan is a procedure that uses a computer linked to an x-ray machine to make a series of detailed pictures of areas inside the body. The pictures are taken from different angles and are used to create 3-dimensional views of tissues and organs. Combining a PET scan with a CT scan can help make the image easier to interpret. PET/CT scans are hybrid scanners that combine both modalities into a single scan during the same examination. 18F-flotufolastat PET/CT imaging may be useful for identifying remaining tumor cells in the prostate after initial hormone therapy, and may help guide delivery of radiation therapy to residual tumors in patients with prostate cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07393867.
Locations matching your search criteria
United States
Massachusetts
Boston
Dana-Farber Cancer InstituteStatus: Active
Contact: Martin T. King
Brigham and Women's HospitalStatus: Active
Contact: Martin T. King
Milford
Dana-Farber/Brigham and Women's Cancer Center at Milford RegionalStatus: Active
Contact: Martin T. King
South Weymouth
Dana-Farber/Brigham and Women's Cancer Center at South ShoreStatus: Active
Contact: Martin T. King
PRIMARY OBJECTIVE:
I. To evaluate whether > 50% of patients will be treated utilizing gross tumor volume (GTV) contours that are highly concordant with those from interim PET/magnetic resonance (MR) scans (GTV-combined-interim) based on the dice coefficient.
SECONDARY OBJECTIVES:
I. To evaluate the geometric accuracies of GTV-combined-baseline and GTV-combined-interim contours, each against principal investigator.
II. To compare volumes of baseline and interim GTV contours.
III. To evaluate percentage of cases, in which focal microboost is not delivered with radiation therapy (RT).
IV. To compare standardized uptake value maximum (SUVmax) values of prostate-specific membrane antigen (PSMA)-PET/CT at baseline, 8-weeks, and 24-weeks.
V. To evaluate fluorine F 18 flotufolastat (18F-flotufolastat) PSMA-PET/CT response at 8-week and 24-week time points.
VI. To compare apparent diffusion coefficient (ADC) contrast ratios of magnetic resonance imaging (MRI) at baseline and 8-weeks.
VII. To evaluate prostate-specific antigen (PSA) response.
VIII. To assess safety and tolerability.
IX. To evaluate patient quality-of-life through Expanded Prostate Cancer Index Composite Short Form (EPIC-26).
X. To evaluate the difficulty in defining GTV contours on PSMA PET and MRI scans, based off of a physician contouring survey.
EXPLORATORY OBJECTIVES:
I. To evaluate pathology biomarkers.
II. To assess blood-based biomarkers.
III. To develop artificial-intelligence methods for focal SBRT treatment planning.
OUTLINE:
Patients receive 18F-flotufolastat intravenously (IV) and undergo PET/CT at baseline. Patients then receive standard of care (SOC) androgen deprivation therapy (ADT) (gonadotrophin releasing hormone [GnRH] agonist and bicalutamide orally [PO] once daily [QD] or GnRH antagonist) for 6 months. Patients receive 18F-flotufolastat IV and undergo PET/CT again in week 8. Starting in week 10, patients undergo SBRT every other day for 5 fractions over two weeks, with or without optional focal microboost. Patients receive 18F-flotufolastat IV and undergo PET/CT again in week 24. Patients also undergo MRI and CT, collection of blood samples, and optional biopsy on study.
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorMartin T. King
