Clinical trial · Interventional
PRE-ProstAtectomy MRI-GuidEd Stereotactic Body RadioTherapy for High-Risk Prostate Cancer Trial (PREPARE SBRT)
NCT03663218CI-TRIAL-00105839PREPARE SBRTactive not recruitingN/AResults postedClinicalTrials.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)
Men with prostate cancer with Gleason Score of 8 or greater or clinical/radiographic evidence of T3 disease will be considered for this trial.
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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5 Gy x 5 fractions | Radiation | — | UNRESOLVED |
| 6.5 Gy x 5 fractions | Radiation | — | UNRESOLVED |
| 6 Gy x 5 fractions | Radiation | — | UNRESOLVED |
| maximum tolerated dose (6.5 Gy x 5 fractions) | Radiation | — | UNRESOLVED |
| recommended phase 2 dose (6.5 Gy x 5 fractions) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- OTHER
- label
- Part 1 - Arm 5 Gy x 5 fractions
- description
- Part 1 uses a modified 3+3 dose escalation/de-escalation design with expansion to define the RP2D in a minimum of 3 to a maximum of 9 patients. DLT is defined as Grade ≥3 GI and/or GU toxicity related to preoperative radiotherapy per Clavien-Dindo within 30 days. Three dose levels are evaluated: 5 Gy, 6 Gy, and 6.5 Gy. At each level, 3 patients are treated over five days. If 0/3 experience DLT, escalate. If 1/3 has DLT, expand to 6. If ≤1/6 have DLT, escalate; if ≥2/6, de-escalate and define the prior dose as MTD. The MTD is expanded to 9 patients. If ≤2/9 have DLT, it is the RP2D; if ≥3/9, further de-escalation occurs. In the arm "Part 1 - Arm 5 Gy x 5 fractions" the participants will receive a dose of 5 Gy for each RT fraction for a total of 5 fractions (total dose 25 Gy).
- interventionNames
- Radiation: 5 Gy x 5 fractions
- type
- OTHER
- label
- Part 1 - Arm 6 Gy x 5 fractions
- description
- Part 1 uses a modified 3+3 dose escalation/de-escalation design with expansion to define the RP2D in a minimum of 3 to a maximum of 9 patients. DLT is defined as Grade ≥3 GI and/or GU toxicity related to preoperative radiotherapy per Clavien-Dindo within 30 days. Three dose levels are evaluated: 5 Gy, 6 Gy, and 6.5 Gy. At each level, 3 patients are treated over five days. If 0/3 experience DLT, escalate. If 1/3 has DLT, expand to 6. If ≤1/6 have DLT, escalate; if ≥2/6, de-escalate and define the prior dose as MTD. The MTD is expanded to 9 patients. If ≤2/9 have DLT, it is the RP2D; if ≥3/9, further de-escalation occurs. In the arm "Part 1 - Arm 6 Gy x 5 fractions" the participants will receive a dose of 6 Gy for each RT fraction for a total of 5 fractions (total dose 30 Gy).
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Men aged greater than equal to18 with histologically confirmed primary prostate cancer. * KPS greater than equal to 70 * Patient with a negative staging bone scan. * Patient can undergo an MRI. * Patient with negative staging CT or MRI of pelvis. Suspicious evidence of nodal involvement on staging CT or MRI of pelvis is defined as greater than 1 cm on short axis. Documented negative biopsy of suspicious node required. * Patient is medically fit to undergo prostatectomy. * Patient has either Gleason Score greater than equal to 8 on biopsy and/or clinical/radiographic evidence of T3 disease. Exclusion Criteria: * Prior history of receiving pelvic radiotherapy. * Patient is unwilling to undergo prostatectomy. * Patient with active inflammatory bowel disease defined as currently receiving therapy for IBD.
References
Publications (0)
Data not yet available
No reference posted for this study.