Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04253483 · ClinicalTrials.gov registry record · Phase 2
Comparison of High-Dose Rate Brachytherapy and Stereotactic Ablative Radiotherapy as Monotherapy for the Treatment of Localized Prostate Cancer
A Phase 2 study of Stage II Prostate Cancer AJCC v8 and Stage I Prostate Cancer AJCC v8, sponsored by Rutgers, The State University of New Jersey.
- Active
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
- 3
- Study locations
NCT04253483: Active Phase 2 study of Stage II Prostate Cancer AJCC v8 and Stage I Prostate Cancer AJCC v8, sponsored by Rutgers, The State University of New Jersey.
NCT04253483 is a Phase 2 study of Stage II Prostate Cancer AJCC v8 and Stage I Prostate Cancer AJCC v8 that is active but no longer recruiting, run by Rutgers, The State University of New Jersey. The registered enrollment target is 14 participants, below the 119-participant average among 21 other Stage II Prostate Cancer AJCC v8 trials with a reported enrollment target (88% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04253483, a Phase 2 study of Stage II Prostate Cancer AJCC v8 and Stage I Prostate Cancer AJCC v8, is active but no longer recruiting, sponsored by Rutgers, The State University of New Jersey.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase II trial compares high-dose rate brachytherapy and stereotactic ablative radiotherapy as monotherapy in treating patients with prostate cancer that has not spread to other parts of the body (localized). High-dose rate brachytherapy delivers radiation directly into the prostate within a few minutes by a single radioactive seed through temporarily placed plastic catheters inside the prostate gland. Stereotactic ablative radiotherapy is an external beam radiation method that delivers large doses of radiation to the cancer in a short period of time, usually 5 treatments. This trial aims to find which of these two approaches is better in terms of patient-reported quality of life.
Primary Outcome
Feasibility is defined as success in enrolling patients, performing the procedures, reporting adverse effects, collecting and managing data across several institutions and patient compliance in completing health-related quality of life questionnaires.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- RADIATION High-Dose Rate Brachytherapy
- PROCEDURE Stereotactic Ablative Radiotherapy
Study Locations (3)
New Jersey
- RWJBarnabas Health - Saint Barnabas Medical Center, Livingston - Livingston
- Rutgers Cancer Institute of New Jersey - New Brunswick
- Rutgers New Jersey Medical School - Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2019-07-17 |
| Est. Completion | 2027-09-01 |
| Phase | Phase 2 |
What the registry record for NCT04253483 still lists
NCT04253483 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 119-participant average among 21 other Stage II Prostate Cancer AJCC v8 trials with a reported enrollment target (88% lower).
The record links to 5 conditions, with Stage II Prostate Cancer AJCC v8 appearing as the primary indexed condition, and to 4 interventions - of which Quality-of-Life Assessment is the first listed.
NCT04253483 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT04253483 about?
NCT04253483 is a clinical study titled "Comparison of High-Dose Rate Brachytherapy and Stereotactic Ablative Radiotherapy as Monotherapy for the Treatment of Localized Prostate Cancer". This phase II trial compares high-dose rate brachytherapy and stereotactic ablative radiotherapy as monotherapy in treating patients with prostate cancer that has not spread to other parts of the body (localized). High-dose rate brachytherapy delivers radiation directly into the prostate within a fe...
What is the current status of trial NCT04253483?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2019-07-17. Estimated completion is 2027-09-01.
What conditions does trial NCT04253483 study?
This clinical trial studies the following conditions: Stage II Prostate Cancer AJCC v8, Stage I Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8, Stage IIB Prostate Cancer AJCC v8, Stage IIA Prostate Cancer AJCC v8.
What interventions are being tested in trial NCT04253483?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), High-Dose Rate Brachytherapy (RADIATION), Stereotactic Ablative Radiotherapy (PROCEDURE).
Who is sponsoring clinical trial NCT04253483?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04253483 being conducted?
This trial has 3 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage II Prostate Cancer AJCC v8
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 NCT04253483's enrollment target sits among peer trials
14 19th of 21 higher than 3 of 21 other Stage II Prostate Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage II Prostate Cancer AJCC v8 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
-
Time-Restricted Eating Versus Nutritional Counseling for the Reduction of Radiation or Chemoradiation Tx Side Effects in Patients With Prostate, Cervical, or Rectal Cancers
RECRUITING · Phase 2
-
Hormone Therapy (Apalutamide) and Image-guided Stereotactic Body Radiation Therapy for the Treatment of Patients With Prostate Cancer, HEATWAVE Trial
RECRUITING · Phase 2
-
Aspirin and Rintatolimod With or Without Interferon-alpha 2b in Treating Patients With Prostate Cancer Before Surgery
ACTIVE NOT RECRUITING · Phase 2
-
Testing the Effects of Low Dose Apalutamide on Prostate-Specific Antigen (PSA) Levels in Men Scheduled for Removal of the Prostate Gland
ACTIVE NOT RECRUITING · Phase 2
-
RElugolix VErsus LeUprolide Cardiac Trial
ACTIVE NOT RECRUITING · Phase 2
-
Focal Ablation With Focal Cryotherapy or HIFU for the Treatment of Men With Localized Prostate Cancer
RECRUITING · NA
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
- NCT02523092 · 14 participants · Phase 4
Use of CXCL9 as a Biomarker of Acthar Efficacy
- NCT04263285 · 14 participants · NA
Treatment of Depression Post-SCI
- NCT04743271 · 14 participants · NA
Food and Circadian Timing
- NCT05065671 · 14 participants · Phase 1
Microbiome Derived Metabolism and Pharmacokinetics
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
- NCT06358040 · started 2026-10 · NA
Opioid Dispenser for Microdiscectomy/Laminectomy