Clinical trial NCT02911922: Randomized Trial of Image -Guided Stereotactic Radiation Therapy (IG-SRT) in Prostate Cancer
Official title: Randomized Trial of Image -Guided Stereotactic Radiation Therapy (IG-SRT) in Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2016-09-22
Enrollment: 1
Sex: MALE
Minimum age (years): 19
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

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.
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.

This study plans to enroll a total of 40 patients with an accrual period of 4 years.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Patient-reported Acute Toxicity Based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4
timeFrame: Baseline to 1 year
Secondary outcomes:
measure: Measure the Effect of Treatment on Patients' Using Health Related Quality of Life Based on Expanded Prostate Cancer Index Composite Questionnaire
timeFrame: 1 year
measure: Number of Participants With Recurrence-free Survival
timeFrame: 1 year
measure: Comparing Several Parameters That Are Involved in Treatment Planning in Patients Randomized to Two Radiation Therapy Modalities.
timeFrame: 5 years
measure: Incidence of Patient-reported Toxicity (Late Toxicity) Based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4
timeFrame: post RT to 1 year
Other outcomes:
measure: Measuring Number of Participants Changes in the Microbiome That is Associated With Normal Tissue Toxicities Resulting From Radiation From Baseline to End of Treatment
timeFrame: baseline, post radiation follow up
measure: Comparing Neutrophile:Lymphocyte Ratio (NLR) at Different Time Points to Assess Impact of SBRT in All the Participants
timeFrame: 1 month, 6 months, 1 year
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Cornell Medicine - New York Presbyterian Hospital
name: Josephine Kang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Cornell Medicine - New York Presbyterian Hospital
name: Silvia Formenti, M.D.
role: PRINCIPAL_INVESTIGATOR
References: