Clinical trial · Interventional
Functional MR-guided Stereotactic Body Radiation Therapy of Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of adequate sample size.
Summary
Brief summary (as posted)
To improve radiation therapy of prostate cancer, the investigators must be able to accurately identify the tumour. By using advanced functional imaging techniques available on state-of-the-art MRI scanners to clearly show the specific location of the tumour inside the prostate, the investigators can use advanced radiation therapy techniques to specifically target the tumor and control it with as few radiotherapy clinic visits as possible. This is different than current techniques which treat the whole prostate gland to the same dose, delivered over 7-8 weeks of daily radiotherapy visits. By increasing the radiation dose to the active tumor while still maintaining adequate radiation dose to the rest of the prostate, the investigators hope to better control prostate cancer and reduce complications to nearby normal tissues.
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 |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic body RT with MR-guided boost | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prostate stereotactic body RT with MR-guided boost
- description
- Patients will receive a dose of 36.25 Gy in 5 fractions to the entire prostate and proximal seminal vesicles with an additional boost to the dominant lesion for a total of 40 Gy in 5 fractions.
- interventionNames
- Radiation: Stereotactic body RT with MR-guided boost
Primary outcomes (1)
- measure
- Quality of Life as per EPIC
- timeFrame
- 6 months
- description
- Expanded Prostate Cancer Index Composite (EPIC) bowel domain
Secondary outcomes (4)
- measure
- Quality of Life as per EPIC and SF-12
- timeFrame
- Up to 5 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Informed consent * Age \>18 years * Histologically confirmed and centrally reviewed prostate adenocarcinoma based * PSA within 60 days * High risk prostate cancer defined as any one of: clinical stage \>= T3, Gleason score \>= 8, or PSA \>=20 and \<50 ng/mL. Exclusion Criteria: * Evidence of lymph node metastasis * Evidence of distant metastases * Prior pelvic radiotherapy or brachytherapy * Previous radical prostatectomy, cryotherapy, or high-frequency ultrasound * Unable to undergo gold seed insertion * Immunosuppressive medications * Inflammatory bowel disease * Unable to undergo MRI * Previous bilateral orchiectomy * Previous hormonal therapy including LHRH agonists (leuprolide, goserelin), LHRH antagonists (degarelix), anti-androgens (bicalutamide, flutamide, nilutamide), surgical castration, and estrogens * Previous finasteride within 14 days. * Previous dutasteride within 180 days.
References
Publications (0)
Data not yet available