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

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexMale
• Healthy volunteersNo

You may be able to join if

• 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

You cannot join if

• 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)

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

• Apalutamide (Drug): Given PO
• Biospecimen Collection (Procedure): Undergo collection of blood samples
• Computed Tomography (Procedure): Undergo PSMA-PET/CT
• Gallium Ga 68 Gozetotide (Other): Undergo PSMA-PET/CT
• Guided Stereotactic Body Radiation Therapy (Radiation): Undergo guided SBRT
• Multiparametric Magnetic Resonance Imaging (Procedure): Undergo multiparametric MRI
• Positron Emission Tomography (Procedure): Undergo PSMA-PET/CT
• Questionnaire Administration (Other): Ancillary studies

Na · Single Group · masking: None

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

• blood samples: Part of the study plan
• CT scans: Part of the study plan
• MRI: Part of the study plan
• PET scans: Part of the study plan
• questionnaires: Part of the study plan
• radiation: Part of the study plan

Main goals

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

Other goals

• Time to biochemical recurrence (BCR)
• Patient-reported outcomes (PROs) on the Expanded Prostate Cancer Index Composite-26 (EPIC-26) urinary domain
• PROs on the EPIC-26 bowel domain
• Radiographic persistence of disease on prostate specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT)
• Radiographic persistence of disease on multiparametric magnetic resonance imaging
• Longitudinal PROs on the EPIC-26 questionnaire in the sexual, urinary, and bowel domains
• Physician-reported acute and late toxicities

Planned enrollment: 95 (estimated).

• UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT06067269

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Jul 16, 2026. Public record; not medical advice.