Hormone Therapy (Apalutamide) and Image-guided Radiation Therapy for Treating Prostate Cancer: HEATWAVE Trial

Sponsor: Jonsson Comprehensive Cancer Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06067269

Provider View

This clinical trial is testing a combination of hormone therapy and precise radiation therapy to treat prostate cancer. The study aims to see if this approach can better control the disease by reducing prostate-specific antigen (PSA) levels, which are indicators of cancer activity.

Patient Parameters

Program Overview

This study is exploring a treatment for prostate cancer that combines a hormone therapy called apalutamide with a precise form of radiation therapy known as image-guided stereotactic body radiation therapy (SBRT). Prostate cancer often needs the hormone testosterone to grow. Apalutamide works by blocking testosterone's effects on cancer cells, potentially stopping their growth. SBRT uses advanced imaging to target and deliver radiation to cancer cells with high precision, possibly killing them with fewer doses and causing less harm to healthy tissue. The goal is to see if this combination can lead to very low PSA levels, which may indicate a better chance of curing the cancer.

Description

The main goal of this study is to see how well the combination of apalutamide and precise radiation therapy can lower PSA levels in patients with a specific type of prostate cancer. Researchers will also look at how long it takes for PSA levels to rise again after treatment, and how the treatment affects patients' quality of life, particularly regarding urinary and bowel functions. They will use surveys to gather this information.

Patients will take apalutamide pills daily for up to 6 or 12 months, depending on their response and tolerance. They will also receive SBRT over 1-2 weeks at the start of the treatment. Throughout the study, patients will have regular MRI scans and blood tests to monitor their progress. After finishing the treatment, patients will have follow-up visits every 3 months for up to 5 years to check on their health and cancer status.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with prostate cancer.
  • Age 18 or older.
  • Classified as having a specific risk level of prostate cancer based on medical guidelines.
  • Have a specific genetic test score.
  • Have a visible tumor in the prostate on an MRI scan.
  • Have undergone a specific type of PET/CT scan.
  • Have a testosterone level of at least 150 ng/dL.
  • Be in good general health with a performance status score of 0 or 1.
  • Have adequate blood counts and organ function based on specific tests.
  • Not taking medications that lower the seizure threshold, or have stopped them at least 4 weeks before the study.

Exclusion Criteria

  • Evidence of spinal cord compression.
  • Previous cancer or radiation treatment in the pelvic area.
  • Other active cancers, except for certain skin or bladder cancers.
  • Unable to undergo radiation or hormone therapy.
  • Specific types of prostate cancer not allowed.
  • Certain bowel or vascular diseases.
  • History of seizures or conditions that may cause seizures.
  • Recent severe heart problems or blood clots.
  • Uncontrolled high blood pressure or digestive issues affecting absorption.
  • Active infections like HIV or hepatitis.
  • Any condition that the study doctor believes would prevent participation.
  • Taking certain medications that cannot be adjusted or stopped.
  • Moderate to severe liver problems.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.