This phase I trial tests how well the combination of focal brachytherapy with prostate-specific membrane antigen (PSMA) - positron emission tomography (PET) and computed tomography (CT) imaging works in treating patients with prostate cancer that has not spread to other parts of the body (localized). PSMA is a cell surface antigen which is highly expressed in prostate cancer. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in this case fluorine F 18 Piflufolastat (18F-DCFPYL). Because some cancers take up 18F-DCFPYL it can be seen with PET. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient’s body. Upon administration, 18F-DCFPYL binds to PSMA expressed on tumor cells allowing the exact location of the tumor cells to be seen through PET. Brachytherapy, also known as internal radiation therapy, uses radioactive seeds placed directly into or near a tumor to kill tumor cells. Currently, treatment for prostate cancer involves treating the entire prostate due to concerns about not knowing where the cancer is exactly located. Brachytherapy with 18F-DCFPYL PET/CT can be used to target seeds only to the areas where cancer is known to be present to reduce toxicity to nearby healthy tissues. Undergoing focal brachytherapy with 18F-DCFPyl PET/CT may kill more tumor cells and be safe and tolerable in patients with localized prostate cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT03861676.
Locations matching your search criteria
United States
Maryland
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer CenterStatus: Active
Contact: Daniel Yeong-Jin Song
Phone: 410-502-5875
PRIMARY OBJECTIVE:
I. To assess for adequate coverage of the combined PET/magnetic resonance (MR)/biopsy based tumor volume (composite clinical target volume, [CTV]) achieved when using ultrasound and fluoroscopy (iRUF) intraoperative dosimetry.
SECONDARY OBJECTIVE:
I. To assess pathologic response and progression rates in treated as well as untreated regions.
EXPLORATORY OBJECTIVES:
I. To assess response rates via prostate specific antigen (PSA) levels.
II. Establish baseline estimates of dose received by uninvolved prostatic tissue.
III. Assess baseline estimates of dose received by normal tissues/structures including urethra, rectum.
IV. Collect quality of life parameters using standardized patient-reported quality of life (QOL) outcomes questionnaires (International Prostate symptom Score [IPSS], Sexual Health Inventory for Men [SHIM], Expanded Prostate Cancer Index Composite [EPIC] Short-Form 26).
V. Obtain preliminary correlations of QOL outcomes versus (vs) doses to normal tissues/structures.
VI. Assess correlation between magnetic resonance imaging (MRI) vs PSMA PET-defined tumor volumes.
OUTLINE:
Patients receive 18F-DCFPyl intravenously (IV) and undergo PSMA PET on study. Patients then undergo focal bracytherapy on study followed by CT scan. Additionally, patients undergo a transrectal ultrasound (TRUS) prior to procedure, and blood collection, magnetic resonance imaging (MRI), and prostate biopsies throughout the study. Patients may also undergo a bone scan during baseline.
After completion of study treatment, patients are followed up every 4 months for 1 year and then every 6 months for 2 years.
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center
Principal InvestigatorDaniel Yeong-Jin Song
