Clinical trial · Interventional
Focal Therapy for Prostate Cancer - A Pilot Study of Focal Low Dose Rate Brachytherapy
FTPC (Focal Therapy for Prostate Cancer): A Pilot Study Using Focal Low Dose Rate Brachytherapy as an Alternative to Active Surveillance and Radical Treatment for Favourable Risk Prostate Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This project will develop and evaluate a treatment plan for prostate focal therapy based on low dose rate brachytherapy. The participants entering this study are those suitable for active surveillance. These participants will be monitored with various imaging methods and interventions such as MR elastography, Transrectal ultrasound elastography, PET/CT and transperineal mapping biopsy to determine the extent of cancer and suitable treatments. Those suitable for focal therapy will be offered the option of low dose rate brachytherapy (LDRB) focal therapy in addition to active surveillance or radical therapy. This study will be used to evaluate the long term use of multi-modal, multi-parametric prostate cancer imaging, combining data from MRI, ultrasound and 11C-choline PET/CT. Such methods can be used to eliminate the need for invasive methods such as mapping biopsies.
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 |
|---|---|---|---|
| Low Dose Radiation Focal Brachytherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Low Dose Radiation Focal Brachytherapy
- description
- Low Dose Radiation Focal Brachytherapy
- interventionNames
- Radiation: Low Dose Radiation Focal Brachytherapy
Primary outcomes (1)
- measure
- Constitute Disease Criteria and Appropriate Treatment Plans
- timeFrame
- Approximately 4 years; upon study completion
- description
- To develop criteria for what constitutes focal disease and treatment plans appropriate for focal LDRB.
Secondary outcomes (1)
- measure
- Quality of Life
- timeFrame
- Approximately 4 years; upon study completion
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must be 18 years of age or older * Must be able to give informed consent * Histologic diagnosis of prostate adenocarcinoma made on transrectal guided prostate biopsy with no fewer than 6 cores taken * The prostate cancer is considered suitable for a strategy of active surveillance as well as conventional radical treatment. * No more than 2 cores from one lobe containing cancer * Gleason sum no greater than 3+4 =7 in any one core * Clinical T stage no higher than T2a * Serum prostate-specific antigen (PSA) no higher than 10 ng/mL * No previous radiation therapy to the pelvis * No prior history of malignancy except non-melanoma skin cancer * Must be suitable for general or spinal anesthesia * Must not be on coumadin or other anticoagulants * Must be suitable for multi-parametric MRI scan (excluded are those with significant renal impairment that would preclude the use of contrast agents and may exclude some patients with cardiac pacemaker, wires, or defibrillator; artificial heart valve; brain aneurysm clip; electrical stimulator for nerves or bones; ear or eye implant; implanted drug infusion pump; coil, catheter, or filter in any blood vessel. Some men with metallic prostheses; shrapnel, bullets, or other metal fragments retained in the body may be excluded as well. Exclusion Criteria: * They are unable to participate in an MRI scan. * They are unable to undergo general or spinal anesthesia. * They are on anticoagulation therapy (blood thinners). * They have had previous radiotherapy to the pelvis.
References
Publications (0)
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