This phase I trial tests the safety, side effects, and best dose of stereotactic body radiation therapy (SBRT) with a simultaneous integrated boost (SIB) to the dominant lesion in treating patients with prostate cancer that has not spread to other parts of the body (localized). Radiation works by damaging the tumor cells in the body and stopping them from growing or spreading. In this trial SBRT involves the delivery of up to 5 high dose radiation treatments, known as fractions. It is a precise form of treatment, which targets small tumors without damaging nearby healthy organs or tissue. SIB allows the simultaneous delivery of different dose levels to a specific site of the tumor. By using the SIB strategy, the dose would be escalated only to the target lesion rather than the entire prostate gland, thereby potentially achieving improvements in controlling the disease while mitigating unwanted treatment-related toxicity. This trial is evaluating the use of 2 fractions administered at a higher radiation dose in combination with SIB to the dominant lesion. If it can be proven that 2 fractions of SBRT with SIB is safer than 5 fractions, this method of treatment may be provided as a standard of care for prostate cancer treatment. This might prove to be an effective treatment option that improves clinical outcomes, limits the amount of side effects patients may experience, and lower the amount of overall provider visits a patient will need to schedule.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05864196.
Locations matching your search criteria
United States
New York
New York
Laura and Isaac Perlmutter Cancer Center at NYU LangoneStatus: Active
Contact: Nima Aghdam
Phone: 212-496-5560
PRIMARY OBJECTIVE:
I. To determine feasibility based on grade 2+ toxicity using physician reported adverse events collected from start of treatment until patient’s final follow up visit, and is graded based on Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.
SECONDARY OBJECTIVES:
I. To determine and assess patient reported quality of life through the collection of Expanded Prostate Cancer Index Composite (EPIC) and International Prostate Symptom Score (IPSS) questionnaires, which will be collected during screening, at the last treatment visit, and at every follow up visit post treatment.
II. To look at oncologic outcomes such as biochemical control, disease free survival, prostate-specific antigen (PSA) nadir, overall survival, and metastasis free survival (MFS).
III. To determine the feasibility and safety of two fraction SBRT in patients with prostate cancer.
OUTLINE:
Patients undergo implantation of fiducial markers in the prostate gland with rectal ultrasound guidance prior to treatment on study. Patients then undergo SBRT with SIB to the dominant lesion for 2 weekly fractions over 60 minutes completed within 18 days. Patients also undergo magnetic resonance imaging (MRI) and computed tomography (CT) during screening as well as blood sample collection during screening and follow-up.
After completion of study treatment, patients are followed up at 30 days, every 3- 4 months for the first 2 years, and then every 6 months until year 5.
Lead OrganizationLaura and Isaac Perlmutter Cancer Center at NYU Langone
Principal InvestigatorNima Aghdam
