Clinical trial · Interventional
HDR vs LDR Brachytherapy as Monotherapy in the Treatment of Localized Prostate Cancer.
Comparison of High-dose- Versus Low-dose-rate Brachytherapy as Monotherapy in the Treatment of Early, Organ Confined Prostate Cancer.
NCT02258087CI-TRIAL-00015792PROMOBRAunknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Investigators compare in a randomized clinical trial the results and side effects of high-dose- and low-dose-rate brachytherapy as monotherapy in the treatment of early, organ confined prostate cancer patients.
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 |
|---|---|---|---|
| Adenocarcinoma of Prostate | Prostate Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HDR Brachytherapy | Radiation | — | UNRESOLVED |
| LDR Brachytherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- LDRPBT
- description
- Patients with low and selected intermediate risk prostate cancer are treated with Prostate LDR brachytherapy as monotherapy. 145 Gy is prescribed to the prostate. I-125 radioactive sources are used. Transperineal approach, rectal ultrasound guidance, inverse treatment planning, real time dose optimization is applied.
- interventionNames
- Radiation: LDR Brachytherapy
- type
- EXPERIMENTAL
- label
- HDRPBT
- description
- Patients with low and selected intermediate risk prostate cancer are treated with prostate HDR brachytherapy as monotherapy. The prescribed dose is 1x19 Gy to the whole prostate. Ir-192 radioactive source is used. Transperineal approach, rectal ultrasound guidance, inverse treatment planning, real time dose optimization is applied.
- interventionNames
- Radiation: HDR Brachytherapy
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) status \<=1 * 40-75 years old * expected life expectancy\>10 years * low risk prostate cancer (Prostate specific antigen (PSA)\<=10ng/ml, gleason score \<7, T status\<=2a), less than 50 % positive biopsy cores * selected intermediate prostate cancer (PSA)=10-\<15ng/ml or gleason score =3+4(but not 4+3), or T2b-c, less than 50 % positive biopsy cores) * International prostate symptom score (IPSS) \<=15 * Prostate volume\<=50cm3 * no pubic interference * no prior prostate operation, except biopsy * no prior radiation to pelvis * patient signed the informed consent Exclusion Criteria: * \<40 years or \>75 years old * PSA\>15 ng/ml gleason score 4+3 , score 8-10 * ECOG\>=2 * T3-4 * percent core positivity \>50 % * TUR operation within six months prior to the brachytherapy prostate volume\<10 cm3 or \>50 cm3 IPSS \>15
References
Publications (0)
Data not yet available
No reference posted for this study.