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RECRUITING
NCT06067269
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Apalutamide

Given PO

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

PROCEDURE

Computed Tomography

Undergo PSMA-PET/CT

OTHER

Gallium Ga 68 Gozetotide

Undergo PSMA-PET/CT

RADIATION

Guided Stereotactic Body Radiation Therapy

Undergo guided SBRT

PROCEDURE

Multiparametric Magnetic Resonance Imaging

Undergo multiparametric MRI

PROCEDURE

Positron Emission Tomography

Undergo PSMA-PET/CT

OTHER

Questionnaire Administration

Ancillary studies

Locations (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States