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HEATWAVE Trial: Apalutamide and Radiation for Prostate Cancer

This study, called HEATWAVE, is looking at a combination of treatments for prostate cancer. It's testing apalutamide, a hormone therapy that blocks testosterone (a hormone prostate cancer often needs to grow), along with image-guided stereotactic body radiation therapy (SBRT). SBRT is a type of radiation that uses imaging to precisely target tumors. The study aims to see how many patients with certain types of prostate cancer (unfavorable intermediate risk) achieve a very low prostate specific antigen (PSA) level of less than 0.2 ng/mL three months after finishing apalutamide. You might be able to join if you are an adult male (18 years or older) with a confirmed diagnosis of prostate adenocarcinoma and meet specific risk criteria. The current status of this study is unclear, and it plans to enroll 95 participants.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 95 participants.
What's involved
Participants will receive apalutamide by mouth and undergo guided SBRT. They will also have blood samples collected and undergo PSMA-PET/CT scans.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is measured three months after completion of apalutamide. Other assessments, like quality of life, are measured up to 24 months after radiotherapy completion, and radiographic persistence of disease is assessed up to 30 months after radiotherapy completion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06067269

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Jonsson Comprehensive Cancer Center
~95 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:ApalutamideBiospecimen CollectionComputed TomographyGallium Ga 68 GozetotideGuided Stereotactic Body Radiation TherapyMultiparametric Magnetic Resonance Imaging

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent of patients achieving prostate specific antigen (PSA) of < 0.2 ng/mL
Measured over Three months after completion of apalutamide

Conditions

Prostate Adenocarcinoma
Stage II Prostate Cancer AJCC v8
Stage IIIA Prostate Cancer AJCC v8
Stage IIIB Prostate Cancer AJCC v8

Explore related trials

Prostate AdenocarcinomaDecipherTestosterone

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Amar Kishan · PRINCIPAL_INVESTIGATOR · UCLA / Jonsson Comprehensive Cancer Center

Who to contact

Christy Palodichuk
[email protected]
310-267-8988
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Confirmed diagnosis of prostate adenocarcinoma
Age ≥ 18
Classified as having National Comprehensive Cancer Network unfavorable intermediate risk prostate cancer (i.e., \[a\] 2 of the following: PSA 10-20 ng/mL, clinical T category 2b-2c, or International Society of Urological Pathology \[ISUP\] grade group 2; \[b\] OR any 1 of \[a\] with ISUP grade group 3 disease; OR \[c\] any 1 of \[a\] with 50% or more cores on systematic biopsy showing prostate cancer)
Have a Decipher genomic classifier score
Have at least one dominant intraprostatic lesion visible on multiparametric MRI (Prostate Imaging-Reporting and Data System \[PI-RADS\] version 2.1 score 4 or 5)
Have underwent a prostate specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT)
Have total testosterone \>= 150 ng/dL
Adequate performance status (Eastern Cooperative Oncology Group \[ECOG\] 0-1)
Hemoglobin ≥ 9.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomization (at screening)
Platelet count ≥ 100,000 x 10\^9/uL independent of transfusion and/or growth factors within 3 months prior to randomization (at screening)
Serum albumin ≥ 3.0 g/dL (at screening)
Glomerular filtration rate (GFR) ≥ 45 mL/min (at screening)
Serum potassium ≥ 3.5 mmol/L (at screening)
Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (Note: In subjects with Gilbert's syndrome, if total bilirubin is \> 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 x ULN, subject may be eligible) (at screening)
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 2.5 x ULN (at screening)
Medications known to lower the seizure threshold (see list under prohibited medications) must be discontinued or substituted at least 4 weeks prior to study entry

Exclusion

Any evidence of spinal cord compression (radiological or clinical)
Prior pelvic malignancy
Prior pelvic radiation
Concurrent malignancy other than adequately treated basal cell or squamous cell skin cancer, non-muscle invasive bladder cancer (NMIBC), or any other cancer in situ currently without evidence of recurrence or progression
Inability to undergo radiotherapy, or hormonal therapy
Primary small cell carcinoma of the prostate (prostate adenocarcinoma with neuroendocrine differentiation is allowed)
Inflammatory bowel disease or active collagen vascular disease
History of any of the following:
Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign central nervous system \[CNS\] or meningeal disease which may require treatment with surgery or radiation therapy)
Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization
Current evidence of any of the following:
Uncontrolled hypertension
Gastrointestinal disorder affecting absorption
Known active infection (eg, human immunodeficiency virus \[HIV\] or viral hepatitis)
Any condition that in the opinion of the investigator would preclude participation in this study
Treatment with CYP2D6 substrates that have a narrow therapeutic index. If an alternative treatment cannot be used, a dose reduction of the CYP2D6 substrate may be considered
Baseline moderate and severe hepatic impairment (Child Pugh class B \& C)

What this trial measures

  • Percent of patients achieving prostate specific antigen (PSA) of < 0.2 ng/mLThree months after completion of apalutamide

    Will be summarized by count and percent along with the 95% confidence interval. This will then be compared to the historical control rate of 70% using a two sample z test for proportions with a one-sided p-value threshold of 0.05.