Single Fractions SBRT for Prostate Cancer

Study Overview
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Brief Summary
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It is a phase I study of radical hypofractionation delivering one single fraction of SBRT in patients with low- and favorable intermediate-risk prostate cancer that will undergo placement of the SpaceOAR hydrogel prior to treatment. Our hypothesis is that treatments can be safely delivered in one single fraction using SBRT provided the separation between the prostate and rectum is increased using the hydrogel

Detailed Description
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There is a pre-treatment visit to the radiation oncology department. A gel is injected between the prostate and the rectum. This procedure is done with the use of a transrectal ultrasound, similarly to the prostate biopsy the patient had. A local anesthetic will be applied to numb the skin and to the underneath tissue where the injection will be performed. The procedure itself will take approximately 20 minutes and after a short observation time, the patient returns home. The next visit (approximately after 7 days after the insertion of the gel), a CT scan and MRI-scan will be done. Prior to the scans, a urinary catheter will be inserted in the bladder through the penis, and removed once the scans are done. Using these images, the doctor and the team involved will perform an individualized planning study to establish the safest way the radiation will enter your body. When the treatment plan is ready, patient is called to receive the single treatment. A urinary catheter again will be inserted in the bladder and the patient will be directed to the room where your treatment will be delivered. The treatment should last approximately 30 minutes. After the treatment, the urinary catheter will be removed.

Official Title
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Single Fractions SBRT in the Treatment of Prostate Cancer: A Phase I Study

Conditions
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Prostate Cancer

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven adenocarcinoma of the prostate. Tl-2b (AJCC 7th edition) Gleason score 6 or 7 (3+4)) or Gleason 7(4+3) and recent PSA < 10 (less than 30 days; must obtained >90 days from stopping dutasteride or >30 days from stopping finasteride) Recent PSA under 15 ng/dL (less than 30 days; must obtained >90 days from stopping dutasteride or >30 days from stopping finasteride) OR Gleason 7(4+3) and recent PSA < 10 (less than 30 days; must obtained >90 days from stopping dutasteride or >30 days from stopping finasteride) International Prostate Symptom Score <16 Prostate gland volume< 80cc Zubrod Performance Status 0-1 within 60 days prior to registration Age >: 18 Patient must be able to provide study-specific informed consent prior to study entry. Exclusion Criteria: Patients who opt to receive another treatment modality, such as surgery, or undergo active surveillance. Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. All patients with in situ carcinoma are eligible for this study (for example, carcinoma in situ of the oral cavity) except patients with carcinoma of the bladder (including in situ bladder cancer or superficial bladder cancer). Evidence of distant metastases Regional lymph node involvement Previous radical surgery (prostatectomy), cryosurgery, or HIFU for prostate cancer Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy Previous hormonal therapy, such as LHRH agonists or antagonists, anti-androgens, estrogens, or surgical castration (orchiectomy) Use of finasteride within 30 days prior to registration. PSA should not be obtained prior to 30 days after stopping finasteride. Use of dutasteride within 90 days prior to registration. PSA should not be obtained prior to 90 days after stopping dutasteride. Previous or concurrent cytotoxic chemotherapy for prostate cancer Severe, active co-morbidity, defined as follows: Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months Transmural myocardial infarction within the last 6 months Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol. (Patients on Coumadin or other blood thinning agents are eligible for this study.) Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.

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: Single Fraction SBRT in the treatment of prostate cancer<br>Prior to treatment, a hydrogel spacer will be inserted between the recutm and prostate. A urinary catheter will also be inserted in the bladder. A single dose of 19Gy will be delivered with an IMRT technique. The treatment should last approximately 30 minutes. After the treatment, the urinary catheter will be removed. | Radiation: Stereotactic Body Radiation Therapy (SBRT)<br>* Shorter radiation therapy means that a higher dose will be offered. To limit side effects of exposure to a high dose, a medical device protecting the rectum will be used. The medical device to be used is called SpaceOAR hydrogel (device). The SpaceOAR hydrogel creates space between the rectum and the prostate, making it much less likely that the rectum is exposed to radiation. It is injected into place prior to the start of radiation treatment using a needle. Patients may be awake or asleep under local anesthesia for the procedure. SpaceOAR hydrogel is not painful, it remains stable during radiation therapy and then is gradually absorbed by the body over the course of approximately six months, once radiation therapy has been completed.<br>* Other names: Space OAR Gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Small bowel or rectal irritation, | To assess acute gastro-intestinal (GI) toxicity such as abdominal cramping, diarrhea, rectal urgency, proctitis, or hematochezia; | 3 months | 
| Bladder complications | Bladder complications including urinary frequency/urgency, dysuria, hematuria, urinary tract infection, and incontinence; | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess late GI and GU toxicity | gastro-intestinal (GI) toxicity such as abdominal cramping, diarrhea, rectal urgency, proctitis, or hematochezia;and GU toxicity such as Bladder complications including urinary frequency/urgency, dysuria, hematuria, urinary tract infection, and incontinence; | 3 years | 
| PSA control | To assess the rate of biochemical control | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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single fraction, SBRT, Space OAR Gel