Randomized Trial of Image -Guided Stereotactic Radiation Therapy (IG-SRT) in Prostate Cancer

Study Overview
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Brief Summary
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Patients with low-risk or favorable intermediate-risk prostate cancer as defined by 1.2016 NCCN criteria will be eligible to participate on this study.

Detailed Description
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This is a randomized, two arm study for patients with low-risk or favorable intermediate-risk prostate cancer as defined by 1.2016 NCCN criteria. Patients will be randomized to either rectal spacer placement or endorectal balloon placement, daily prior to each radiation treatment. Endorectal balloon (ERB): Immobilization device manually placed into the rectum prior to radiation treatment planning CT and daily treatment delivery, to immobilize the prostate and reduce prostate motion. Rectal spacer (RS): Biodegradable gel that is transperineally injected between the rectum and prostate under transrectal ultrasound guidance, to increase physical distance and thereby reduce radiation dose to the anterior rectal wall. The spacer begins to biodegrade in 2-3 months, and is fully absorbed within 6 months. This study plans to enroll a total of 40 patients with an accrual period of 4 years.

Official Title
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Randomized Trial of Image -Guided Stereotactic Radiation Therapy (IG-SRT) in Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: Endorectal Balloon
* Device: Rectal Spacer
* Radiation: Radiation therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Biopsy-proven diagnosis of prostate adenocarcinoma, diagnosed within 1 year of randomization Either NCCN-defined low-risk disease (T1c-T2a, Gleason score 3+3=6, PSA <10), intermediate-risk disease (Gleason score 3+4=7, 4+3=7, T2b-c and/or PSA 10-20; ) or high-risk disease due to Gleason score 8-10 and/or PSA >20 ng/ml, but not due to T3-T4 disease on physical exam. Exclusion Criteria: History of prior pelvic radiation (external beam or brachytherapy) Prior or concurrent lymphomatous/hematogenous malignancy, or history of prior/concurrent invasive malignancy during the past 5 years Very high risk prostate cancer (T3b-T4 on clinical exam, Primary Gleason pattern 5, or >4 cores with Gleason score 8-10) History of prior chemotherapy for prostate cancer History of irritable bowel disease Evidence of lymph node involvement AUA score >15 Prostate size > 90 cc

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 99 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endorectal balloon - Radiation therapy<br>Group 1 : Endorectal balloon (ERB): Immobilization device manually placed into the rectum prior to radiation treatment planning CT and daily treatment delivery, to immobilize the prostate and reduce prostate motion. Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days. | Device: Endorectal Balloon<br>* Endorectal balloon (ERB): Immobilization device manually placed into the rectum prior to radiation treatment planning CT and daily treatment delivery, to immobilize the prostate and reduce prostate motion. Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days.<br>Radiation: Radiation therapy<br>* Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days.<br>|
| Experimental: Rectal spacer - Radiation therapy<br>Group 2 : Rectal spacer (RS): Biodegradable gel that is transperineally injected between the rectum and prostate under transrectal ultrasound guidance, to increase physical distance and thereby reduce radiation dose to the anterior rectal wall. The spacer begins to biodegrade in 2-3 months, and is fully absorbed within 6 months. Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days. | Device: Rectal Spacer<br>* Rectal spacer (RS): Biodegradable gel that is transperineally injected between the rectum and prostate under transrectal ultrasound guidance, to increase physical distance and thereby reduce radiation dose to the anterior rectal wall. The spacer begins to biodegrade in 2-3 months, and is fully absorbed within 6 months. Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days.<br>Radiation: Radiation therapy<br>* Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Patient-reported Acute Toxicity Based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4 | To compare acute toxicity (as defined by CTCAE v4.0) and to compare Rectal dose (V35, max rectal dose). Acute radiation toxicities are side effects that occur on treatment or in the immediate post treatment period (within 90 days from the start of radiation treatment). | Baseline to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the Effect of Treatment on Patients' Using Health Related Quality of Life Based on Expanded Prostate Cancer Index Composite Questionnaire | To compare health-related quality of life (HRQOL) measured using the Expanded Prostate Cancer Index Composite (EPIC) instrument for bowel, urinary and sexual domains. scores are transformed linearly to a 0-100 scale (see following page: EPIC scoring), with higher scores representing better HRQOL. American Urological Association (AUA) scores ranges from 0-30 scores where, score greater than 15 indicate high degree of urinary symptoms and scores less than 15 indicate low degree of urinary symptoms. | 1 year | 
| Number of Participants With Recurrence-free Survival | 1 year | 1 year | 
| Comparing Several Parameters That Are Involved in Treatment Planning in Patients Randomized to Two Radiation Therapy Modalities. | To compare the dose distribution of the 2 techniques, specifically: coverage of the PTV DVH of organs at risk (OAR) prostate motion and shifts required during treatment | 5 years | 
| Incidence of Patient-reported Toxicity (Late Toxicity) Based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4 | To compare late toxicity (as defined by CTCAE v4.0). Late toxicities are toxicities that occur greater than 3 months after radiation therapy completion. | post RT to 1 year |