Clinical trial · Interventional
Single Fraction Real-time High-Dose-Rate Brachytherapy in Patients With Low and Intermediate Risk Prostate Cancer
Prospective Phase II Trial of Single Fraction Real-time High-Dose-Rate (19-HDR) Brachytherapy in Patients With Low and Intermediate 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)
High-dose rate brachytherapy (HDR-BT) is an advanced technology theorized to be more advantageous than LDR-BT and External Beam Radiotherapy (EBRT), to the patient himself, and in terms of resource allocation. Studies of HDR-BT monotherapy have encouraging results in terms of biochemical control, patient survival and toxicity, but there are still certain limitations that preclude recommending HDR-BT monotherapy outside the setting of a clinical trial. The primary endpoint of this study is to evaluate the safety, tolerance and impact on quality of life (QoL) of the BT-HDR 19Gy administered in single fraction in patients with low and intermediate risk prostate cancer. Secondary endpoint is to measure the efficacy, in terms of cancer control and satisfaction of the patients undergoing the experimental treatment. Forty nine patients will be recruited for the experimental procedure Quality of Life, tolerance, gastrointestinal and genitourinary toxicity will be assessed using standardized procedures and scales. Patient satisfaction with the procedure will be appraised using five-category predetermined Likert scale questions. Two different types of intermediate analyses will be performed: with 15 and 30 recruited patients. The experimental treatment tested in this study is very innovative. Since prostate cancer is the most frequent cancer in men in Spain, this trial results are very likely to have a major impact on the standard therapy for prostate cancer in our National Health Service, allowing for a higher number of Hospitals within our country and other countries starting protocols of HDR BT 19Gy in single fraction.
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 |
|---|---|---|---|
| MRI-TRUS fusion guided Single Frac HDR | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MRI-TRUS fusion guided Single Frac HDR
- description
- Patients treated with a Single Fraction Real-Time High-Dose-Rate (HDR 19Gy)
- interventionNames
- Radiation: MRI-TRUS fusion guided Single Frac HDR
Primary outcomes (2)
- measure
- Safety measured by i) urinary retention rate and duration ii) maximum International Prostate Symptom Score and time to normalize
- timeFrame
- 12 months
- description
- Data to be collected are: i) urinary retention rate and duration ii) maximum International Prostate Symptom Score and time to normalize
- measure
- Quality of Life measured by alidated instruments including International Prostate Symptom Score and the urinary, bowel and sexual domains of EPIC
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men older than 18 years old * Histologically confirmed diagnosis of adenocarcinoma of the prostate * Clinical stage T1c/T2a disease * Low and Intermediate risk disease defined as either Gleason 6 or Gleason 7 and PSA \< 20 ng/ml. * Prostate volume \< 60 cc as determined by ultrasound, CT or MRI * Life expectancy of more than 10 years * Willing to give informed consent to participate in this clinical trial * Able and willing to complete Expanded Prostate Index Composite (EPIC) questionnaire * Eastern Cooperative Oncology Group (ECOG) of 0 - 2. * Give competent informed consent to participate in this trial. Exclusion Criteria: * Documented nodal or distant metastases * Previous pelvic radiotherapy * Previous trans-urethral resection of prostate, previous prostatectomy or HIFU * Use of androgen deprivation therapy. Use of 5-alpha-reductase inhibitors is permitted * Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) \>19 * Contra-indication to radical prostate radiotherapy * Significant medical co-morbidity rendering patient unsuitable for general anaesthetic
References
Publications (1)
- DERIVEDGomez-Iturriaga A, Casquero F, Pijoan JI, Minguez P, Espinosa JM, Irasarri A, Bueso A, Cacicedo J, Buchser D, Bilbao P. Health-related-quality-of-life and toxicity after single fraction 19 Gy high-dose-rate prostate brachytherapy: Phase II trial. Radiother Oncol. 2018 Feb;126(2):278-282. doi: 10.1016/j.radonc.2017.10.039. Epub 2017 Nov 15. PMID 29153462