Actively Recruiting

Phase 2
Age: 18Years +
MALE
NCT06067269

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

Led by Jonsson Comprehensive Cancer Center · Updated on 2025-07-15

95

Participants Needed

1

Research Sites

191 weeks

Total Duration

On this page

Sponsors

J

Jonsson Comprehensive Cancer Center

Lead Sponsor

J

Janssen Scientific Affairs, LLC

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of prostate adenocarcinoma
  • Age 18 years or older
  • Unfavorable intermediate risk prostate cancer as defined by specific PSA levels, clinical categories, or grade groups
  • Decipher genomic classifier score available
  • At least one dominant intraprostatic lesion visible on multiparametric MRI with PI-RADS score 4 or 5
  • Completed PSMA PET/CT scan
  • Total testosterone level equal or above 150 ng/dL
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Hemoglobin level equal or above 9.0 g/dL
  • Platelet count equal or above 100,000 x 10^9/uL
  • Serum albumin equal or above 3.0 g/dL
  • Glomerular filtration rate (GFR) equal or above 45 mL/min
  • Serum potassium equal or above 3.5 mmol/L
  • Serum total bilirubin less than or equal to 1.5 times upper limit of normal (ULN), with exceptions for Gilbert's syndrome
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) less than 2.5 times ULN
  • Medications that lower seizure threshold stopped or substituted at least 4 weeks before study entry
Not Eligible

You will not qualify if you...

  • Evidence of spinal cord compression
  • Prior pelvic malignancy
  • Prior pelvic radiation therapy
  • Current other cancers except treated skin cancer, non-muscle invasive bladder cancer, or cancer in situ without recurrence
  • Inability to undergo radiotherapy or hormonal therapy
  • Primary small cell carcinoma of the prostate (neuroendocrine differentiation allowed)
  • Inflammatory bowel disease or active collagen vascular disease
  • History of seizure or conditions increasing seizure risk, including certain brain diseases or recent stroke
  • Severe or unstable heart conditions or recent serious heart events within 6 months
  • Uncontrolled hypertension
  • Gastrointestinal disorders affecting absorption
  • Known active infections like HIV or viral hepatitis
  • Other conditions that may prevent study participation as judged by the investigator
  • Treatment with certain CYP2D6 substrate drugs without alternatives or dose adjustments
  • Moderate or severe liver impairment (Child Pugh class B or C)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States, 90095

Actively Recruiting

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Research Team

C

Christy Palodichuk

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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