RecruitingPhase 2NCT06067269

Hormone Therapy (Apalutamide) and Image-guided Stereotactic Body Radiation Therapy for the Treatment of Patients With Prostate Cancer, HEATWAVE Trial

High Precision Stereotactic Radiotherapy to the Whole Prostate With Focal Boost and Varying Hormonal Therapy (HEATWAVE)


Sponsor

Jonsson Comprehensive Cancer Center

Enrollment

95 participants

Start Date

Mar 28, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (called HEATWAVE) tests whether combining hormone therapy (apalutamide) with a precise, high-dose radiation technique (stereotactic body radiation therapy, or SBRT) can improve outcomes for men with unfavorable intermediate-risk prostate cancer — a stage where the cancer has intermediate aggressiveness and some high-risk features. **You may be eligible if...** - You are 18 or older and have confirmed prostate cancer - You have been classified as having "unfavorable intermediate-risk" prostate cancer based on PSA levels, tumor stage, and biopsy grade - You have had a genomic test (Decipher score) on your prostate cancer - You have a visible lesion on MRI (PI-RADS 4 or 5) - You have had a PSMA PET scan to assess cancer spread **You may NOT be eligible if...** - Your cancer is low-risk, favorable intermediate-risk, high-risk, or metastatic - You have not had the required genomic and imaging assessments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGApalutamide

Given PO

PROCEDUREBiospecimen Collection

Undergo collection of blood samples

PROCEDUREComputed Tomography

Undergo PSMA-PET/CT

OTHERGallium Ga 68 Gozetotide

Undergo PSMA-PET/CT

RADIATIONGuided Stereotactic Body Radiation Therapy

Undergo guided SBRT

PROCEDUREMultiparametric Magnetic Resonance Imaging

Undergo multiparametric MRI

PROCEDUREPositron Emission Tomography

Undergo PSMA-PET/CT

OTHERQuestionnaire Administration

Ancillary studies


Locations(1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

View Full Details on ClinicalTrials.gov

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NCT06067269


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