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NCT05698576: TPF-LITT
TRANBERG® Transperineal MR/US Fusion Laser--Induced Thermal Therapy for Men With Prostate Cancer
NA trial testing TRANBERG® Transperineal Fusion Laser--Induced Thermal Therapy of Prostate Cancer (TPF-LITT) in Prostate Cancer in 20 participants. Currently enrolling.
27 January 2023
Quick facts
| Lead sponsor | Urological Research Network, LLC |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 16 March 2022 |
| Primary completion | 27 January 2023 |
| Estimated completion | 30 January 2033 |
| Sites | 1 location across United States |
Drugs / interventions tested
- TRANBERG® Transperineal Fusion Laser--Induced Thermal Therapy of Prostate Cancer (TPF-LITT)
Conditions studied
- Prostate Cancer — all drugs for Prostate Cancer →
- Adverse Effects Surgery — all drugs for Adverse Effects Surgery →
- MRI — all drugs for MRI →
- Ultrasound — all drugs for Ultrasound →
Sponsor
Urological Research Network, LLC
Who can join
Adults 50 to 80, male only, with Prostate Cancer or Adverse Effects Surgery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is set up as a phase I prospective, single center, device interventional pilot study carried in office setting under local anesthesia. It will assess the tolerance and safety of target fusion ablation of prostate cancer tumors using Laser Induced Thermal Therapy (TFA-LITT) guided by fusion imaging in men 50 to 80 years of age with low to intermediate risk prostate cancer Prostate Cancer is currently managed with in a discrete fashion where patients either enroll in active surveillance protocols (No intervention) or undergo full intervention via whole gland treatments - most commonly radical surgery or radiation. These treatments have not shown definitive gains in all cause survival and not uncommonly harbor undesirable adverse effects, most notably: impotency and incontinence. Such events elicit significant and noticeable changes on a male lifestyle and for most prostate cancer tumors are considered overtreatment. This study aims to evaluate the use of TFA-LITT in the office setting under local anesthesia - greatly decreasing patient perioperative surgical risk - focused on the organ sparing cancer lesion ablation, where organ function is preserved. The fundamental objective is to determine the tolerance and safety of TFA-LITT in men with low to intermediate risk prostate cancer, successful performed in the outpatient office-based setting under local anesthesia directed by fusion imaging. Secondary objectives include: 1-Biopsy proven cancer control of ablated areas 12 months after procedure; 2-Uroflowmetry and urinary function Patient Reported Outcome Measures (PROMs) at one, three, six, nine and 12 months; 3- Sexual function Patient Reported Outcome Measures (PROMs) at one, three, six, nine and 12 months; 4- MRI changes of ablated area one, three and 12 months after TFA-LITT; 5- Absence or presence of ejaculation after TFA-LITT.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05698576
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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- NCT07027124 — Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Ris · Phase 2 · recruiting
- NCT07426094 — PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate · Phase 2, PHASE3 · recruiting
Other Urological Research Network, LLC trials
Trials by the same sponsor.
- NCT04760483 — Office Based Transperineal Laser Ablation for Benign Prostatic Hyperplasia HYPERPLASIA · Phase 1 · unknown
- NCT05218811 — Cryaoablation Assisted Partial Nephrectomy a Non Ischemic Approach · NA · 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 NCT05698576 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Urological Research Network, LLC
- Last refreshed: 26 January 2023
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/NCT05698576.
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