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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: Recruiting Phase 2 study of Prostate Adenocarcinoma and Stage II Prostate Cancer AJCC v8, sponsored by Jonsson Comprehensive Cancer Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Will be summarized by count and percent along with the 95% confidence interval. This will then be compared to the historical control rate of 70% using a two sample z test for proportions with a one-sided p-value threshold of 0.05.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2024-03-28 |
| Est. Completion | 2027-12-01 |
| Phase | Phase 2 |
What NCT06067269 shows while recruiting
NCT06067269 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (56% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Prostate Adenocarcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06067269's enrollment target sits among peer trials
95 42nd of 99 higher than 58 of 99 other Prostate Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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