Clinical trial · Interventional
Single Arm Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade Group 4 Prostate Cancer
A Single Arm Phase II Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade Group 4 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): No accrual interest
Summary
Brief summary (as posted)
This study involves Stereotactic Body Radiation Therapy (SBRT) followed by prostatectomy (removal of the prostate). SBRT is a relatively new radiation technique in which a few doses of radiation are delivered to small, well-defined tumors. It has been used effectively in other cancers like lung and liver. The radiation will be given for only 5 days. The purpose of this study is to compare the effects, good and/or bad, of different doses of SBRT given before prostatectomy.
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 |
|---|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Stereotactic Body Radiation Therapy, followed by Prostatectomy
- description
- Patients will receive 6 Gy per day of Stereotactic Body Radiation Therapy (SBRT) per day for 5 days, followed by prostatectomy in 3 weeks.
- interventionNames
- Device: Stereotactic Body Radiation Therapy (SBRT)
Primary outcomes (2)
- measure
- Measure of PSA (Prostate Specific Antigen)
- timeFrame
- Up to 12 months
- description
- Measure of PSA through treatment. PSA is expected to be undetectable (\<0.2 mg/ml) after prostatectomy and radiation therapy.
- measure
- Number of symptomatic adverse anastomotic events
- timeFrame
- Up to 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
* Histologically proven prostate adenocarcinoma. * Clinical stage ≤T3a based on digital rectal exam (DRE) and ≤T3a based on MRI (within 3 months); N0-Nx; M0-Mx, or Gleason score 4 + 4. No more than 1 lymph node \>1 cm. * PSA ≤ 50 ng/ml, obtained within 3 months * Prostate volume: ≤60 cc. * IPSS score ≤15. * No previous radiotherapy to the prostate or lower pelvis. * Lymph node risk of \<35% using https://www.mskcc.org/nomograms/prostate/pre\_op. * No prior radical prostatectomy or cryotherapy of the prostate (prior transurethral resection or laser ablation are permitted). * No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion. * No history of an invasive malignancy (other than this prostate cancer, or non-metastatic basal or squamous skin cancers) in the last 3 years. * No androgen deprivation therapy (ADT) can be prescribed prior to or during radiation therapy. * Participant must be able to have gold fiducial markers placed in the prostate. Note: patients can be enrolled after fiducial markers have been placed, as long as the procedure was done in accordance with the protocol (Section 4.2.2). * Eastern Cooperative Oncology Group (ECOG) performance status ≤2 * Ability to understand and the willingness to sign a written informed consent document. * Willing to fill out quality of life questionnaires.
References
Publications (0)
Data not yet available