Clinical trial · Interventional
RAD 1801: Pilot Study of Intra-Urethral Radiotransponder Beacon Guided Focal Prostate Stereotactic Body Radiotherapy
Pilot Study of Intra-Urethral Radiotransponder Beacon Guided Focal Prostate Stereotactic Body Radiotherapy
NCT03458234CI-TRIAL-00077296RAD1801terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No longer manufacturing radiotransponder beacons. No similar product available. The results are no longer expected to have a scholarly or clinical impact. Terminating the study before it reaches its target accrual.
Summary
Brief summary (as posted)
This study offers focal therapy for prostate cancer by using an intra-urethral radiotransponder temporarily placed during radiotherapy. The study aims to improve the risk-benefit ratio of therapy for early prostate cancer and potentially lessen symptom burden over time.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 16 French Foley Catheter | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Focal SBRT with intra-urethral radiotransponder
- description
- This study will enroll patients that have a confirmed histology of prostate cancer. They will undergo a 3T MRI scan as well as a CT simulation with 16 French Foley Catheter containing dummy beacons for treatment planning purposes. The patient will then receive focal stereotactic body radiotherapy (SBRT) at a dose of 40 gy in 5 total fractions. Patients will be followed for 24 total months with specific follow-ups at 3, 6, 9, 12, 18, and 24 months.
- interventionNames
- Device: 16 French Foley Catheter
Primary outcomes (1)
- measure
- Confirm the Feasibility of Focal Prostate Stereotactic Body Radiotherapy (SBRT) With Real Time Guidance by Intra-urethral Radiotransponder Beacons.
- timeFrame
- 2 years
- description
- Confirm the technical feasibility of using focal prostate stereotactic body radiotherapy (SBRT) instead of traditional treatment methods using a 16-french Foley catheter and real time guidance by intra-urethral radiotransponder beacons.Feasibility will be defined as the ability of the treatment to take place as planned.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * All patients must have histologically confirmed adenocarcinoma of the prostate, with biopsies obtained within 12 months of registration * Gleason score 3+3 or 3+4 * PSA \<10 ng/mL within 3 months of enrollment * Clinical stage T1a-T2a by digital rectal exam * Up to 2 intraprostatic nodules visible on MRI, with combined volume \<50% of the total prostate volume * Karnofsky Performance Status (KPS) \>70%. * Life expectancy \>10 years * Age ≥ 19 years * Subjects given written informed consent Exclusion Criteria: * \>2 MRI defined nodules representing prostate cancer * Total volume of MRI nodules exceeding 50% of total prostate volume * Positive biopsy core in sextant region without MRI defined nodule (i.e. biopsy proven MRI occult prostate cancer) * American Urological Association (AUA) urinary score ≥ 18. * History of inflammatory bowel disease. * Prior pelvic surgery * Prior treatment for prostate cancer * Patients using immunosuppressive medications or other medications that may increase radiation toxicity such as methotrexate, sirolimus, tacrolimus, or colchicine that are unable to discontinue these medications during SBRT course. Use of corticosteroids is not considered an exclusion criteria. * Platelet count \< 70,000/µL * Patients unable to discontinue anti-platelet or anti-coagulant medicine such as clopidogrel, dabigatran, warfarin, or low molecular weight heparin. Use of aspirin is not an exclusion criteria. * Contraindication to MRI such as implanted devices. * Metallic pelvic implants resulting in imaging artifact within the prostate on MRI or CT
References
Publications (0)
Data not yet available
No reference posted for this study.