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NCT04253483
Comparison of High-Dose Rate Brachytherapy and Stereotactic Ablative Radiotherapy as Monotherapy for the Treatment of Localized Prostate Cancer
Phase 2 trial testing High-Dose Rate Brachytherapy in Stage I Prostate Cancer AJCC v8 in 14 participants. Participants enrolled and being followed up; not accepting new ones.
1 September 2026
Quick facts
| Lead sponsor | Rutgers, The State University of New Jersey |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 14 |
| Start date | 17 July 2019 |
| Primary completion | 1 September 2026 |
| Estimated completion | 1 September 2027 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- High-Dose Rate Brachytherapy
- Quality-of-Life Assessment
- Questionnaire Administration
- Stereotactic Ablative Radiotherapy
Conditions studied
- Stage I Prostate Cancer AJCC v8 — all drugs for Stage I Prostate Cancer AJCC v8 →
- Stage II Prostate Cancer AJCC v8 — all drugs for Stage II Prostate Cancer AJCC v8 →
- Stage IIA Prostate Cancer AJCC v8 — all drugs for Stage IIA Prostate Cancer AJCC v8 →
- Stage IIB Prostate Cancer AJCC v8 — all drugs for Stage IIB Prostate Cancer AJCC v8 →
Sponsor
Rutgers, The State University of New Jersey
Who can join
18 and older, male only, with Stage I Prostate Cancer AJCC v8 or Stage II Prostate Cancer AJCC v8. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Ablative Radiotherapy in Prostate Cancer: Stereotactic Body Radiotherapy and High Dose Rate Brachytherapy.
Ma TM, Lilleby O, Lilleby WA, Kishan AU. · · 2020 · cited 5× · PMID 33276562 · DOI 10.3390/cancers12123606
Verify or expand the search:
- PubMed search for NCT04253483
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of High-Dose Rate Brachytherapy
Trials testing the same drug.
- NCT07468903 — Focal Radiation Therapy (HDR-Brachytherapy) for the Treatment of Prostate Cancer · NA · not yet recruiting
- NCT07276360 — Hypofractionated Radiotherapy for the Treatment of Locally Advanced Cervical Cancer in Uganda · Phase 2 · recruiting
- NCT04945642 — High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for the Treatment of Prostate Adenocarcinoma · NA · recruiting
- NCT04725903 — Proton Radiation Therapy for the Treatment of Patients With High Risk Prostate Cancer · NA · recruiting
- NCT04399824 — Focal Radiation Therapy for the Treatment of Low or Intermediate-Risk Prostate Cancer · NA · withdrawn
Other recruiting trials for Stage I Prostate Cancer AJCC v8
Currently open trials in the same condition.
- NCT07276438 — Image-Guidance and Online Adaptation With Stereotactic Body Radiation Therapy for the Treatment of Localized Prostate Ca · NA · recruiting
- NCT06940271 — Feasibility and Effect of Wrapping Nerves With a Multi-Layer Perinatal Tissue Allograft During Prostatectomy · NA · recruiting
- NCT06995053 — Computed Tomography-Guided Stereotactic Body Radiation Therapy With Intrafraction Motion Monitoring for the Treatment of · NA · recruiting
- NCT06733350 — Testosterone Replacement Therapy for the Treatment of Low Testosterone in Hypogonadal Men With Localized Prostate Cancer · Phase 4 · recruiting
- NCT06325046 — Adaptive Radiation Therapy (ART) Stereotactic Ablative Body Radiotherapy (SABR) for Primary Localized Prostate Cancer · NA · recruiting
Other Rutgers, The State University of New Jersey trials
Trials by the same sponsor.
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- NCT07525011 — Comparative Study of Denture Fabrication Techniques · NA · not yet recruiting
- NCT06834204 — Advancing Care Coordination Between Cancer and Primary Care Teams for Complex Cancer Survivors · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04253483 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Rutgers, The State University of New Jersey
- Last refreshed: 17 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04253483.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing