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NCT04842890 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of Pencil Beam Scanning Proton Stereotactic Body Radiation Therapy for Prostate Cancer
A Phase 2 study of Prostate Cancer, sponsored by The New York Proton Center.
- Active
- Registry status
- Phase 2
- Development phase
- 61
- Enrollment target
- 1
- Study location
NCT04842890 is a Phase 2 study of Prostate Cancer that is active but no longer recruiting, run by The New York Proton Center. The registered enrollment target is 61 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04842890, a Phase 2 study of Prostate Cancer, is active but no longer recruiting, sponsored by The New York Proton Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 61 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single arm phase II study of image-guided pencil beam scanning proton SBRT (40Gy RBE in 5 fractions delivered every other day) for patients with low- and intermediate-risk prostate cancer. The primary aim is to assess GU/GI toxicity of proton SBRT and compare this to historic outcomes associated with photon-based prostate SBRT. The primary endpoint is 2-year grade 3+ GU/GI toxicity free rate by CTCAE v5.0, which is expected to be ≥95%. Toxicity will be evaluated by the treating radiation oncologist at least once during SBRT, then following SBRT at 1, 3, 6, 12, 18, and 24 months. The treatment will be considered safe if grade 3 or higher GU/GI toxicity free rate at 2 years is \>85% (95% rate expected with a 10% non-inferiority margin). The accrual goal is 61 patients over 3 years. To ensure that unexpected significant toxicity is identified, all grade 3 or higher toxicities will be reported to the study PI and the trial will stop accruing if at any point 4 or more patients experience a grade 3 or higher toxicity after completing SBRT. This is felt to be conservative given the vast experience with photon SBRT at this dose with an expected G3+ toxicity of \~5%. Secondary objectives are to examine patient-reported urinary, gastrointestinal, sexual, and financial outcomes using IPSS, EPIC-26, and COST questionnaires at the same follow-up timepoints as above. Baseline measures of these domains will be obtained prior to treatment as well. Clinical outcomes will also be evaluated with PSA measured at each follow-up, as well as prostate MRI and biopsies at 2 years. Patients will be followed for at least 2 years to determine rates of PSA relapse, salvage treatment, development of metastases, death from prostate cancer, and overall survival. A dosimetric comparison will be performed where each patient will be planned for proton and photon SBRT to determine possible advantages of proton SBRT.
Conditions Studied
Interventions
- RADIATION Pencil Beam Scanning Proton SBRT
Study Locations (1)
New York
- The New York Proton Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2021-01-08 |
| Est. Completion | 2031-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04842890
The ClinicalTrials.gov registry entry for NCT04842890 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (90% lower). The listed sponsor is The New York Proton Center, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which Pencil Beam Scanning Proton SBRT is the first listed.
NCT04842890 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT04842890 about?
NCT04842890 is a clinical study titled "Phase II Study of Pencil Beam Scanning Proton Stereotactic Body Radiation Therapy for Prostate Cancer". This is a single arm phase II study of image-guided pencil beam scanning proton SBRT (40Gy RBE in 5 fractions delivered every other day) for patients with low- and intermediate-risk prostate cancer. The primary aim is to assess GU/GI toxicity of proton SBRT and compare this to historic outcomes asso...
What is the current status of trial NCT04842890?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2021-01-08. Estimated completion is 2031-01.
What conditions does trial NCT04842890 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT04842890?
The interventions under investigation include: Pencil Beam Scanning Proton SBRT (RADIATION).
Who is sponsoring clinical trial NCT04842890?
This trial is sponsored by The New York Proton Center, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04842890 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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