Clinical trial · Interventional
Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Prostate Cancer Undergoing Surgery
Phase I Feasibility Trial of Preoperative Adjuvant Stereotactic Body Radiotherapy for Patients at High Risk of Local Failure After Prostatectomy
- 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)
This phase I trial studies stereotactic body radiation therapy (SBRT) in treating patients with prostate cancer that is likely to come back or spread (high-risk) undergoing surgery. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Delivering radiotherapy before prostatectomy by SBRT is more convenient, conformal, and may spare normal tissues better than delivering radiotherapy after prostatectomy.
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 |
|---|---|---|---|
| Stage III Prostate Adenocarcinoma AJCC v7 | Prostate Adenocarcinoma | CURATED_BROADER | 0.78 |
| Stage II Prostate Adenocarcinoma AJCC v7 | Prostate Adenocarcinoma | CURATED_BROADER | 0.78 |
| Stage I Prostate Adenocarcinoma American Joint Committee on Cancer (AJCC) v7 | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Stereotactic Body Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (SBRT)
- description
- Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Other: Quality-of-Life Assessment
- Radiation: Stereotactic Body Radiation Therapy
Primary outcomes (1)
- measure
- Number of Participants Who Completed the Maximum Time Allowed on Study Without Severe Acute Surgical Complications
- timeFrame
- At 4 weeks post surgery
Secondary outcomes (4)
- measure
- Number of Participants With Genitourinary Toxicities and Gastrointestinal Toxicities
- timeFrame
- Up to 1 year
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed primary non-metastatic adenocarcinoma of the prostate * Patient desires and is medically fit to undergo prostatectomy * Karnofsky performance status (KPS) \>= 70 * Patients on androgen deprivation therapy (ADT) are allowed * For confirmation of high risk local failure status, patients will have any one of the following: * Computed tomography (CT) or magnetic resonance imaging (MRI) demonstrating seminal vesicle invasion (SVI) or extraprostatic extension (EPE) within 1 year of enrollment into the study * Pre-biopsy prostate-specific antigen (PSA) \>= 20 * Gleason score 7-10 (Gleason 7 must be 4+3), presence of any Gleason 5 (even if a tertiary score) as determined at diagnostic biopsy * Gleason score 7 and \> 50% of biopsy cores positive for prostate cancer * Clinical stage \>= T3 (staging by imaging acceptable) * An image-guided biopsy (via Artemis Ultrasound with MRI co-registration) is encouraged but not required if not performed as standard of care biopsy Exclusion Criteria: * Distant metastases, based upon: * CT scan or MRI of the abdomen/pelvis or prostate specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) within 120 days prior to registration and * Bone scan or PSMA PET/CT within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis prior to registration * Patient is unable or unwilling to sign consent * Patient is considered low-risk and would not have received adjuvant radiation therapy (RT) outside of this study
References
Publications (0)
Data not yet available