Clinical trial · Interventional
Dose Escalation Study of Preoperative SBRT for High Risk Prostate Cancer
A Phase I Dose Escalation Study of Preoperative Stereotactic Body Radiation Therapy (SBRT) for High Risk Prostate Cancer
NCT02572284CI-TRIAL-00063326completedPhase 1ClinicalTrials.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)
The purpose of this study is to compare the effects, good and/or bad, of different doses of SBRT given before prostatectomy. Depending when participants enter the study, they will be treated with either 5 or 6 gray (Gy) per day of radiation. A Gy is a measure of radiation dose. The standard dose is 10Gy per day when SBRT is the only treatment to the prostate and no surgery is planned. The researchers want to see which dose of radiation will work best with the least amount of side effects. About 4-6 weeks after SBRT, participants will have a 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prostatectomy | Procedure | — | UNRESOLVED |
| Quality of Life Questionnaires | Other | — | UNRESOLVED |
| Stereotactic Body Radiation Therapy (SBRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose Escalation of SBRT
- description
- Stereotactic Body Radiation Therapy (SBRT) followed by prostatectomy and Quality of Life questionnaires. The radiation will be given for only 5 days. Conventional radiation to the prostate is given over 7-8 weeks.
- interventionNames
- Radiation: Stereotactic Body Radiation Therapy (SBRT)
- Procedure: Prostatectomy
- Other: Quality of Life Questionnaires
Primary outcomes (1)
- measure
- Dose Limiting Toxicity
- timeFrame
- Up to 28 ± 5 days post-prostatectomy
- description
- Acute dose-limiting toxicity and quality of life due to preoperative SBRT followed by robotic-assisted laparoscopic radical prostatectomy at 14 ± 5 days and 28 ± 5 days post-prostatectomy in high risk prostate cancer patients. In order to assess the toxicity of preoperative SBRT, the severity of specific events will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 form where a score of ≥3 is considered dose-limiting.
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically-proven prostate adenocarcinoma. * Clinical stage ≤T3a based on digital rectal exam and/or ≤T3a based on MRI (if done); N0-Nx; M0-Mx (AJCC 7th Edition) * Prostate-specific antigen (PSA) ≤ 80 ng/ml, obtained within 3 months. * Patients belonging in the National Comprehensive Cancer Network (NCCN) high recurrence risk group. High risk: Clinical stage T3a, or Gleason score = 8-10, or PSA \>20 ng/mL. * Prostate volume: ≤ 80 cc on transrectal ultrasound * IPSS score ≤15 * Zubrod performance status 0-2 or equivalent * No prior total prostatectomy or cryotherapy of the prostate. Prior transurethral resection or laser ablation is permitted. * No prior radiotherapy to the prostate or lower pelvis * 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 5 years * No androgen deprivation therapy (ADT) can be prescribed prior to or during radiation therapy * Must be able to have gold fiducial markers placed in the prostate or, if patient already has fiducial markers placed, they must be in accordance with the protocol specifications * Ability to understand and the willingness to sign a written informed consent document * Willingness to fill out IPSS, SHIM, and EPIC quality of life forms * Age ≥18 years * IPSS (AUA) score ≤15 Exclusion Criteria: * Does not have a diagnosis of prostate adenocarcinoma * Has very low risk, low risk, intermediate risk or very high risk disease as defined by the NCCN * Has stage N1 or M1 (metastatic) disease * Has a PSA of greater than 80 ng/ml obtained no greater than 3 months prior to randomization * Prostate volume greater than 80 cc on transrectal ultrasound * Zubrod performance status 3 or greater * Prior total prostatectomy or cryotherapy of the prostate * Prior radiation therapy to the pelvis * Implanted hardware which limits treatment planning or delivery (determined by the investigator). * Diagnosis of an invasive malignancy within 5 years (other than current prostate cancer or non-metastatic basal or squamous skin cancers) * The use of androgen deprivation therapy (ADT) prior to registration or during radiation * Inability to have gold fiducial markers placed in the prostate, or fiducial markers already placed, that are not in accordance with the protocol * Unwilling or inability to give informed consent * Not willing to fill out IPSS, SHIM, and EPIC quality of life questionnaires * IPSS score \>15
References
Publications (0)
Data not yet available
No reference posted for this study.