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

Study acronym: HEATWAVE
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary completion date: Dec 1, 2026 to Dec 30, 2026
    • Study completion date: Dec 1, 2027 to Dec 30, 2027
    v9
  2. Site contact updatedv8
  3. Site contact updatedv7
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 31, 2024 to Mar 28, 2024
    • Site details revised
    v6
  5. Primary completion date: Dec 1, 2025 to Dec 1, 2026
    • Start date: Mar 1, 2024 to Dec 31, 2024
    • Study completion date: Dec 1, 2026 to Dec 1, 2027
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Start date: Dec 1, 2023 to Mar 1, 2024v4
  2. Start date: Oct 1, 2023 to Dec 1, 2023
    • Primary completion date: Oct 1, 2025 to Dec 1, 2025
    • Study completion date: Oct 1, 2025 to Dec 1, 2026
    v3
  3. Interventions: Apalutamide (Drug), Biospecimen Collection (Procedure), Computed Tomography (Procedure), Gallium Ga 68 Gozetotide (Other), MRI-guided… to Apalutamide (Drug), Biospecimen Collection (Procedure), Computed Tomography (Procedure), Gallium Ga 68 Gozetotide (Other), Guided…
    • Study description shortened, about 2 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06067269
Lead Sponsor Jonsson Comprehensive Cancer Center
Collaborators: Janssen Scientific Affairs, LLC
Conditions
(from sponsor)		 Prostate Adenocarcinoma, Stage II Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8
Related terms Prostatic Neoplasms
Enrollment 95 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov