Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 2 study of Prostate Cancer, sponsored by The New York Proton Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The NCI Common Terminology Criteria for Adverse Events v5.0 is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term.
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 |
What the registry record for NCT04842890 still lists
NCT04842890 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (90% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
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 NCT04842890's enrollment target sits among peer trials
61 419th of 735 higher than 316 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Trial of Neoadjuvant Enoblituzumab vs SOC in Men With High-Risk Localized Prostate Cancer
RECRUITING · Phase 2
-
Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate Cancer
RECRUITING · Phase 2
-
Post-prostatectomy Radiation Therapy--Moderate Versus Ultra-hypofractionated (Also Known as Stereotactic Body Radiation Therapy [SBRT])
RECRUITING · Phase 2
-
A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
RECRUITING · Phase 2
-
Utility of Hyperpolarized 13C-pyruvate Metabolic Magnetic Resonance Imaging
RECRUITING · Phase 2
-
High Intensity Focused Ultrasound in Prostate Cancer
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04115306 · 61 participants · Phase 1
Phase 1/1b/2 Study of Oral PMD-026 in Patients With Metastatic Breast Cancer
- NCT05070845 · 61 participants · Phase 2
Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia
- NCT05187832 · 61 participants · Phase 1
A Study of AND019 in Women With ER Positive HER2 Negative Advanced or Metastatic Breast Cancer
- NCT05269316 · 61 participants · Phase 1
Study to Evaluate IMP9064 as a Monotherapy or in Combination in Patients With Advanced Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI