Clinical trial · Interventional
MRI Assisted Focal Boost With HDR Monotherapy for Prostate Cancer Patients
MRI Assisted Focal Boost Integrated With HDR Monotherapy Study in Low and Intermediate Risk Prostate Cancer Patients (MARS)
- 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)
Radiation therapy plays an important role in the management of prostate cancer. In recent years it has become evident that higher doses of radiation are required to optimize disease control. The limiting factor of escalating dose to the prostate is the surrounding normal tissue. Despite advances in escalating radiation therapy, failures still occur in 20-30% of patients most often at the site of the original primary disease. As such there is growing interest in further dose escalating to the area of primary disease burden.The aim of this work is to look at the feasibility and toxicities of an integrated focal boost to whole gland prostate treatment using high dose rate brachytherapy.
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 assisted focal boost with HDR monotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MRI assisted HDR monotherapy
- description
- HDR monotherapy to the whole prostate gland (19Gy/1) with MRI assisted focal boost to intraprostatic nodule up to 22.5Gy
- interventionNames
- Radiation: MRI assisted focal boost with HDR monotherapy
Primary outcomes (1)
- measure
- Acute GU and GI toxicities
- timeFrame
- 3mo
- description
- Measured according to NCI CTCAE v4.0
Secondary outcomes (5)
- measure
- Late GU and GI toxicities
- timeFrame
- 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed diagnosis of adenocarcinoma of the prostate 2. Low and Intermediate risk disease defined as T1-T2c, Gleason \< 7 and PSA \< 20 ng/ml. 3. Prostate volume \< 60 cc as determined by US, CT or MRI 4. Ability to undergo MR imaging 5. Provide written informed consent 6. Identified MR nodule (PIRADs 4/5) Exclusion Criteria: 1. Ineligible for MR imaging due to contraindications 2. Documented nodal or distant metastases 3. Previous pelvic radiotherapy 4. Previous trans-urethral resection of prostate, previous prostatectomy or HIFU 5. Use of androgen deprivation therapy. Use of 5-alpha-reductase inhibitors permitted 6. Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) \>15 7. Contra-indication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease 8. Significant medical co-morbidity rendering patient unsuitable for general anaesthetic
References
Publications (0)
Data not yet available