Single Arm Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade Group 4 Prostate Cancer

Study Overview
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Brief Summary
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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.

Official Title
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A Single Arm Phase II Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade Group 4 Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: Stereotactic Body Radiation Therapy (SBRT)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stereotactic Body Radiation Therapy, followed by Prostatectomy<br>Patients will receive 6 Gy per day of Stereotactic Body Radiation Therapy (SBRT) per day for 5 days, followed by prostatectomy in 3 weeks. | Device: Stereotactic Body Radiation Therapy (SBRT)<br>* SBRT treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of PSA (Prostate Specific Antigen) | Measure of PSA through treatment. PSA is expected to be undetectable (<0.2 mg/ml) after prostatectomy and radiation therapy. | Up to 12 months | 
| Number of symptomatic adverse anastomotic events | Number of symptomatic anastomotic events related to pre-operative SBRT. | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Catheterization Time | Average time of catheterization following prostatectomy | Up to 4 weeks post surgery | 
| Mean Hospital Stay | Average time of hospitalization after prostatectomy | Up to 2 week post surgery | 
| Quality of Life assessment | Quality of Life will be assessed using 2 questionnaires: International Prostate Symptom Score (IPSS) and Sexual Health Inventory for Men (SHIM). The IPSS is an eight question questionnaire of symptoms ranging from 0 not at all to 5 always. The SHIM is a five question questionnaire ranging from 1 almost never or never to 5 almost always or always to determine erectile dysfunction. | Baseline, at 2 weeks, 4 weeks, 2 months and every 3 months up to 12 months post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High Risk Prostate Cancer, prostate, radiation therapy