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Hormone Therapy (Apalutamide) and Image-guided Stereotactic Body Radiation Therapy for the Treatment of Patients With Prostate Cancer, HEATWAVE Trial
Sponsor: Jonsson Comprehensive Cancer Center
Summary
This phase II trial evaluates apalutamide in combination with image-guided stereotactic body radiation therapy (SBRT) for the treatment of patients with prostate cancer. Prostate cancer usually needs the hormone testosterone to grow. Apalutamide is a hormone therapy that blocks the effect of testosterone on prostate tumor cells. This may help stop the growth of tumor cells that need testosterone to grow. Image-guided SBRT is a standard treatment for some types of prostate cancer. This treatment combines imaging of cancer within the body, with the delivery of therapeutic radiation doses produced on a linear accelerator machine. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Combining apalutamide with image-guided SBRT may increase a prostate cancer patient's chances of achieving an extremely low prostate specific antigen response, which is an early predictor of disease cure.
Official title: High Precision Stereotactic Radiotherapy to the Whole Prostate With Focal Boost and Varying Hormonal Therapy (HEATWAVE)
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
95
Start Date
2024-03-28
Completion Date
2027-12-01
Last Updated
2025-07-15
Healthy Volunteers
No
Conditions
Interventions
Apalutamide
Given PO
Biospecimen Collection
Undergo collection of blood samples
Computed Tomography
Undergo PSMA-PET/CT
Gallium Ga 68 Gozetotide
Undergo PSMA-PET/CT
Guided Stereotactic Body Radiation Therapy
Undergo guided SBRT
Multiparametric Magnetic Resonance Imaging
Undergo multiparametric MRI
Positron Emission Tomography
Undergo PSMA-PET/CT
Questionnaire Administration
Ancillary studies
Locations (1)
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States