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NCT06067269 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Prostate Adenocarcinoma and Stage II Prostate Cancer AJCC v8, sponsored by Jonsson Comprehensive Cancer Center.

Recruiting
Registry status
Phase 2
Development phase
95
Enrollment target
1
Study location

NCT06067269 is a Phase 2 study of Prostate Adenocarcinoma and Stage II Prostate Cancer AJCC v8 that is actively recruiting participants, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 95 participants, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (56% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06067269, a Phase 2 study of Prostate Adenocarcinoma and Stage II Prostate Cancer AJCC v8, is actively recruiting participants, sponsored by Jonsson Comprehensive Cancer Center.

RECRUITING
Registry status
Phase 2
Development phase
95 participants
Enrollment target
1
Study location

Study 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. 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.

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • DRUG Apalutamide
  • OTHER Gallium Ga 68 Gozetotide
  • RADIATION Guided Stereotactic Body Radiation Therapy

Study Locations (1)

California

  • UCLA / Jonsson Comprehensive Cancer Center - Los Angeles

Trial Details

FieldValue
Enrollment Target 95 participants
Start Date 2024-03-28
Est. Completion 2027-12-01
Phase Phase 2

Sponsor

Jonsson Comprehensive Cancer Center

321 total trials

What the Registry Record Tells You About NCT06067269

The ClinicalTrials.gov registry entry for NCT06067269 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (56% lower). The listed sponsor is Jonsson Comprehensive Cancer Center, which has 321 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Prostate Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT06067269 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT06067269 about?

NCT06067269 is a clinical study titled "Hormone Therapy (Apalutamide) and Image-guided Stereotactic Body Radiation Therapy for the Treatment of Patients With Prostate Cancer, HEATWAVE Trial". 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 testost...

What is the current status of trial NCT06067269?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 95 participants. The study started on 2024-03-28. Estimated completion is 2027-12-01.

What conditions does trial NCT06067269 study?

This clinical trial studies the following conditions: Prostate Adenocarcinoma, Stage II Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8.

What interventions are being tested in trial NCT06067269?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Apalutamide (DRUG), Gallium Ga 68 Gozetotide (OTHER), Guided Stereotactic Body Radiation Therapy (RADIATION).

Who is sponsoring clinical trial NCT06067269?

This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06067269 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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