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Prostate AdenocarcinomaPhase 2HEATWAVENCT06067269

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

A Phase 2 study testing Apalutamide, Biospecimen Collection and Computed Tomography in people with Prostate Adenocarcinoma and Stage II Prostate Cancer AJCC v8, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Apalutamide, Biospecimen Collection and Computed Tomography
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
95 participants
Where
1 siteUnited States
Study dates
28 Mar 2024to 30 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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)
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  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Christy Palodichuk contact

310-267-8988

cpalodichuk@mednet.ucla.edu

United States1 site, 1 recruiting

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

    Maria Casado, 310-794-6913, Casado@mednet.ucla.edu

    Amar Kishan

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To assess prostate specific antigen (PSA) complete response rates in patients with unfavorable intermediate risk prostate cancer who are receiving apalutamide monotherapy in conjunction with magnetic resonance imaging stereotactic body radiotherapy with precision dose-escalation and de-escalation to involved and uninvolved areas of the prostate, respectively.

SECONDARY OBJECTIVES:

  1. Assessing time to biochemical recurrence (BCR; PSA ≥ nadir PSA + 2 ng/mL) among patients initially meeting primary endpoint.

II. Assessing patient-reported genitourinary quality of life, as assessed by the Expanded Prostate Cancer Index Composite-26 (EPIC-26) survey instrument 24 months after radiotherapy completion.

III. Assessing patient-reported bowel quality of life, as assessed by the EPIC-26 survey instrument 24 months after radiotherapy completion.

IV. Assessing radiographic persistence of disease on a prostate specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) six months following hormonal therapy completion.

  1. Assessing radiographic persistence of disease on a multiparametric MRI at fixed intervals (i.e., 6, 12, 18, 24, 30) months after radiotherapy completion.

VI. Assessment of longitudinal changes in patient-reported quality of life metrics on the EPIC-26 survey instrument.

VII. Physician-reported acute and late toxicities as per the Common Terminology Criteria for Adverse Events (CTCAE) scale version (v)5.0.

OUTLINE:

Patients receive apalutamide orally (PO) once daily (QD) on days 1-28 of each cycle. Cycles repeat every 28 days for up to 6 or 12 months in the absence of disease progression or unacceptable toxicity. Patients undergo SBRT for 5 fractions over 1-2 weeks beginning on day 1 of cycle 1. Patients also undergo multiparametric MRI and collection of blood samples throughout the trial. Patients undergo PSMA-PET/CT scans during screening and follow up.

After completion of study treatment, patients are followed up every 3 months for up to 24 months after SBRT and then up to 60 months after SBRT.

Being tested
Apalutamide, Biospecimen Collection, Computed Tomography, Gallium Ga 68 Gozetotide, Guided Stereotactic Body Radiation Therapy
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ApalutamideDrug

    Also called ARN 509, ARN-509, ARN509, Erleada

    Given PO

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo collection of blood samples

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo PSMA-PET/CT

  • Gallium Ga 68 GozetotideOther

    Also called (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC, (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC

    Undergo PSMA-PET/CT

  • Guided Stereotactic Body Radiation TherapyRadiation

    Undergo guided SBRT

  • Multiparametric Magnetic Resonance ImagingProcedure or surgery

    Also called MP-MRI, mpMRI, Multi-parametric MRI, Multiparametric MRI

    Undergo multiparametric MRI

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PSMA-PET/CT

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT06067269
Study groupRoleWhat they receive
Treatment (apalutamide, SBRT)ExperimentalPatients receive apalutamide PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 6 or 12 months in the absence of disease progression or unacceptable toxicity. Patients undergo SBRT for 5 fractions over 1-2 weeks beginning on day 1 of cycle 1. Patients also undergo multiparametric MRI and collection of blood samples throughout the trial. Patients undergo PSMA-PET/CT scans during screening and follow up.
Receives: Drug: Apalutamide; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Other: Gallium Ga 68 Gozetotide; Radiation: Guided Stereotactic Body Radiation Therapy; Procedure: Multiparametric Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent of patients achieving prostate specific antigen (PSA) of < 0.2 ng/mL

    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.

    Measured: Three months after completion of apalutamide

Secondary outcomes (7)

  1. Time to biochemical recurrence (BCR)

    Evaluated among patients initially meeting the primary endpoint. BCR is defined as PSA >= nadir PSA + 2 ng/mL. Time to BCR will be reported descriptively for each patient. Five-year biochemical recurrence free survival will be estimated by the Kaplan-Meier method as well as descriptively (mean, standard deviation, median, first and third quartiles, minimum, maximum).

    Measured: We will follow patients for five years following completion of radiotherapy. Biochemical disease status will be checked every 3 months for the first year, and every 6 months thereafter.

  2. Patient-reported outcomes (PROs) on the Expanded Prostate Cancer Index Composite-26 (EPIC-26) urinary domain

    Changes will be analyzed with respect to whether they represent minimally important differences.

    Measured: 24 months after completion of stereotactic body radiation therapy (SBRT)

  3. PROs on the EPIC-26 bowel domain

    The analysis of both acute and late changes in the bowel domain of the EPIC instrument will be stratified for use of hydrogel spacers or not, as these may reduce both acute and late gastrointestinal bowel symptoms.

    Measured: 24 months after completion of SBRT

  4. Radiographic persistence of disease on prostate specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT)

    Defined by expert reader using the criterion of standardized uptake value within 20% of pre-SBRT PSMA PET/CT. Will be reported as a binary value (persistent versus not persistent).

    Measured: 6 months after hormonal therapy completion

  5. Radiographic persistence of disease on multiparametric magnetic resonance imaging

    Defined by expert reader using a composite of apparent diffusion coefficient, size, and ktrans. Will be reported as a binary value (persistent vs. not persistent).

    Measured: At 6 months, 12 months, 18 months, 24 and 30 months after radiotherapy completion

  6. Longitudinal PROs on the EPIC-26 questionnaire in the sexual, urinary, and bowel domains

    For the EPIC-26 instrument, these will be represented by changes from baseline in the urinary incontinence, urinary obstruction, bowel, sexual function, and hormone/vitality domains. Changes will be analyzed with respect to whether they represent minimally important differences.

    Measured: Up to 60 months

  7. Physician-reported acute and late toxicities

    Evaluated per the Common Terminology Criteria for Adverse Events scale version 5.0. Rates will be reported descriptively. The 5-year cumulative incidences of late grade ≥ 2 genitourinary and gastrointestinal toxicity will be analyzed using a cumulative incidence framework. The analysis of gastrointestinal toxicities (acute and late) will be stratified by the use of hydrogel spacers.

    Measured: We will follow patients for five years following completion of radiotherapy. Acute toxicity will be scored within the first 90 days after radiation. Late toxicity and patient-reported outcomes will be assessed every 3 months for the first year, and every

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2023
  2. Study start28 Mar 2024
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
95 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06067269
Sponsor's protocol ID
23-000429
Other IDs
NCI-2023-06647
Acronym
HEATWAVE
Status last verified
Jul 2026
First submitted
21 Sep 2023
Last updated
17 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apalutamide, Biospecimen Collection and Computed Tomography in people with Prostate Adenocarcinoma and Stage II Prostate Cancer AJCC v8, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Christy Palodichuk (310-267-8988, cpalodichuk@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of patients achieving prostate specific antigen (PSA) of < 0.2 ng/mL (time frame: Three months after completion of apalutamide). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06067269.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.

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