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Hormone Therapy

Hormone + Radiation Therapy for Prostate Cancer (HEATWAVE Trial)

Phase 2

Recruiting

Led By Amar Kishan

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Adequate performance status (Eastern Cooperative Oncology Group [ECOG] 0-1)

Must not have

Prior pelvic malignancy

Inflammatory bowel disease or active collagen vascular disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6 months, 12 months, 18 months, 24 and 30 months after radiotherapy completion

Awards & highlights

No Placebo-Only Group

Summary

This trial combines hormone therapy and a radiation therapy to treat prostate cancer, with the aim of increasing the chances of a cure.

Who is the study for?

Men aged 18+ with confirmed prostate adenocarcinoma, testosterone levels ≥150 ng/dL, and specific risk factors for prostate cancer. They must have undergone certain imaging tests and have adequate organ function. Excluded are those with spinal cord compression, prior pelvic malignancy or radiation, certain heart conditions within the past 6 months, seizure history or risks, uncontrolled hypertension, absorption-affecting GI disorders, active infections like HIV/hepatitis, or severe liver impairment.

What is being tested?

The HEATWAVE trial is testing if hormone therapy using Apalutamide combined with image-guided Stereotactic Body Radiation Therapy (SBRT) can improve outcomes in men with prostate cancer. SBRT delivers precise high-dose radiation to tumors while sparing normal tissue. The goal is to see if this combination helps lower a marker called PSA which indicates disease cure.

What are the potential side effects?

Apalutamide may cause fatigue, rash, joint pain and falls; it might also affect thyroid hormones leading to hypothyroidism. Image-guided SBRT could result in urinary symptoms like frequency/urgency/burning sensation during urination as well as bowel changes such as diarrhea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I stopped taking any seizure-risk increasing meds 4 weeks ago.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have a Decipher test score.

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My hemoglobin level is at least 9.0 g/dL without transfusions or growth factors in the last 3 months.

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I have been diagnosed with prostate cancer.

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I am 18 years old or older.

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My MRI shows a significant prostate lesion with a high PI-RADS score.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had cancer in my pelvic area before.

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I have inflammatory bowel disease or an active connective tissue disorder.

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I have a history of seizures or conditions that could lead to seizures.

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My blood pressure is currently not under control.

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I have had radiation therapy to my pelvic area before.

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I cannot have radiotherapy or hormonal therapy.

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My liver is not working well (moderate to severe issues).

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I have signs of pressure on my spinal cord.

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I have a digestive condition that affects how my body absorbs food.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6 months, 12 months, 18 months, 24 and 30 months after radiotherapy completion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6 months, 12 months, 18 months, 24 and 30 months after radiotherapy completion

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months, 12 months, 18 months, 24 and 30 months after radiotherapy completion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

PROs on the EPIC-26 bowel domain

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

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (apalutamide, SBRT)Experimental Treatment8 Interventions

Patients 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Multiparametric Magnetic Resonance Imaging

2021

Completed Early Phase 1

~10

Apalutamide

2015

Completed Phase 2

~5750