Clinical trial · Interventional
MRI Guided Radiation Therapy for the Treatment of High Risk Prostate Cancer
Phase 2 Study of Extreme Hypofractionation Including Pelvic Nodes for High Risk Prostate Cancer Using MgRT (MRI Guided Radiation Therapy)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Loss of required MRI resources needed to conduct protocol-specified procedures
Summary
Brief summary (as posted)
This phase II trial tests whether magnetic resonance imaging (MRI)-guided hypofractionated radiation therapy works to reduce treatment time and side effects in patients with high risk prostate cancer. MRI-guided hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time directly to diseased tissue, reducing damage to healthy tissue. Using MRI-guided radiation therapy on areas of the prostate and pelvic lymph nodes may shorten overall treatment time compared to the longer standard of care therapy and may reduce the number and/or duration of side effects.
Conditions
Conditions (3)
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 Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Stage IIIB Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIC Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Antiandrogen Therapy | Drug | — | UNRESOLVED |
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Bone Scan | Procedure | — | UNRESOLVED |
| Computed Tomography | Procedure | — | UNRESOLVED |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| MRI-guided Intensity-Modulated Radiation Therapy | Procedure | — | UNRESOLVED |
| PSMA PET Scan | Procedure | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (MRI-guided IMRT, ADT)
- description
- Patients undergo MRI-guided IMRT on study and receive SOC ADT throughout the trial. Patients may also undergo PSMA PET, CT, MRI, and bone scans at screening and undergo collection of blood samples throughout the trial.
- interventionNames
- Procedure: MRI-guided Intensity-Modulated Radiation Therapy
- Drug: Antiandrogen Therapy
- Procedure: PSMA PET Scan
- Procedure: Computed Tomography
- Procedure: Magnetic Resonance Imaging
- Procedure: Bone Scan
- Procedure: Biospecimen Collection
- Other: Quality-of-Life Assessment
Primary outcomes (1)
- measure
- Rate of late grade 2+ genitourinary (GU) toxicity
- timeFrame
- At 1 year
- description
- Per Common Terminology Criteria for Adverse Events version 5.0 compared to rate of toxicity in POP-RT trial. Will be estimated for the entire sample that receives the intervention, treating death from any cause (other than treatment) as a competing risk and censoring subjects who drop out before experiencing toxicity at time of last follow-up. A point estimate of cumulative incidence at 1 year will be estimated from this curve along with a two-sided 90% confidence interval. If the upper bound of the interval is less than 20%, the null hypothesis will be rejected.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age: above 18 years * Participants must be histologically proven, adenocarcinoma prostate * Localized to the prostate without positive pelvic lymph node involvement * No distant metastatic disease assessed by pretreatment PSMA PET or bone scan and CT scan * High risk prostate cancer as defined by National Comprehensive Cancer Network (NCCN): Gleason score of 8- 10, clinical stage T3a or higher, or prostate specific antigen (PSA) \> 20 ng/mL * Ability to receive long term hormone therapy * Karnofsky performance score (KPS) \> 70 * No prior history of therapeutic irradiation to pelvis * Patient willing and reliable for follow-up and quality of life (QOL) * English speaking/reading Exclusion Criteria: * Evidence of distant or pelvic metastasis at any time since presentation * Life expectancy \< 2 years * Previous radiation therapy (RT) to prostate or prostatectomy * A previous trans-urethral resection of the prostate (TURP) * Severe urinary symptoms or with severe International Prostate Symptom Score (IPSS) score despite being on hormonal therapy for 6 months which in the opinion of the physician precludes RT * Patients with known obstructive symptoms with stricture * Any contraindication to radiotherapy such as inflammatory bowel disease
References
Publications (0)
Data not yet available