Clinical trial · Interventional
Feasibility and Safety Study Using Preoperative High-Dose Single-Fraction Image-Guided Radiotherapy for Men Undergoing Radical Prostatectomy at High-Risk for Extraprostatic Cancer
Phase I Feasibility and Safety Study Using Preoperative High-Dose Single-Fraction Image-Guided Radiotherapy for Men Undergoing Radical Prostatectomy at High-Risk for Extraprostatic 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 accrual
Summary
Brief summary (as posted)
This study is being done to test the safety of a single high-dose of radiation therapy before radical prostatectomy (removal of the prostate). The investigators want to find out what effects, good and/or bad, the radiation will have on men undergoing prostatectomy. The investigators are especially interested in men who are at risk for having cancer cells that have spread outside the prostate.
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 |
|---|---|---|---|
| High-Dose Single-Fraction Image-Guided Radiotherapy for Men Undergoing Radical Prostatectomy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- High-Dose Single-Fraction Image-Guided Radiotherapy
- description
- This will assess the feasibility and safety of this approach in men at high-risk for extraprostatic prostate cancer undergoing RP. This initial trial has been designed in a manner intended to emphasize patient comfort and safety.
- interventionNames
- Radiation: High-Dose Single-Fraction Image-Guided Radiotherapy for Men Undergoing Radical Prostatectomy
Primary outcomes (1)
- measure
- To assess the feasibility and safety of single-fraction image-guided intensity modulated radiotherapy (IG-IMRT).
- timeFrame
- 1 year
- description
- Given prior to radical prostatectomy (RP) in men at high risk for extraprostatic cancer.
Secondary outcomes (3)
- measure
- To analyze the changes in prostate perfusion induced by single-fraction IG-IMRT.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy-proven prostate cancer verified at MSKCC. The biopsy will include a minimum of 10 cores * Radical Prostatectomy (RP) chosen as the therapeutic method * The size of the prostate will be \< 70 cc by transrectal ultrasound or endorectal MRI imaging * No radiographic evidence of lymph node metastases, bone metastases or soft tissue disease * Risk of extraprostatic cancer of \> 40% based on the MSKCC surgical nomogram * Age \> or = to 18 years * KPS \> or = to 80 * Able to tolerate immobilization cradle positioning Exclusion Criteria: * Allergic reaction to intravenous CT contrast (if premedicated, pt will not be excluded) * Prior radiation to the planned target region * Patients receiving concurrent chemotherapy * Neoadjuvant hormonal therapy Luteinizing-hormone-releasing hormone(LHRH)agonist and/or antiandrogen) * Prior transurethral resection of the prostate * Normal tissue directly overlying target precluding ability to limit the bowel, bladder, rectum or other tissue to less than or equal to 15-16 Gy dose constraints * Dominant prostatic lesion within 3 mm from the anterior rectal wall by imaging studies * Creatinine clearance \<60 ml/min/1.73m2
References
Publications (0)
Data not yet available