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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Prostate Cancer	Device: Endorectal Balloon; Device: Rectal Spacer; Radiation: Radiation therapy	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	40 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Randomized Trial of Image -Guided Stereotactic Radiation Therapy (IG-SRT) in Prostate Cancer
Study Start Date :	September 2016
Estimated Primary Completion Date :	September 2019
Estimated Study Completion Date :	September 2019

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Endorectal balloon - Radiation therapy; 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; 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. Radiation: Radiation therapy; 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.
Experimental: Rectal spacer - Radiation therapy; 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; 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. Radiation: Radiation therapy; 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.

Outcome Measures

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Primary Outcome Measures :

1. To assess acute GI/GU toxicity [ Time Frame: 4 years ]
   To compare acute GI/GU toxicity (as defined by CTCAE v4.0) and to compare Rectal dose (V35, max rectal dose)

Secondary Outcome Measures :

1. Health-related quality of Life questionnaire [ Time Frame: 5 years ]
   To compare health-related quality of life (HRQOL) measured using the Expanded Prostate Cancer Index Composite (EPIC) instrument for bowel, urinary and sexual domains
2. To measure recurrence-free survival [ Time Frame: 5 years ]
   To compare biochemical recurrence-free survival at 1, 2 and 5 years
3. To compare radiation dose distribution of the two techniques [ Time Frame: 5 years ]

   To compare the dose distribution of the 2 techniques, specifically:

   1. coverage of the PTV
   2. DVH of organs at risk (OAR)
   3. prostate motion and shifts required during treatment
4. To assess late GI/GU toxicity [ Time Frame: 5 years ]
   To compare late GI/GU toxicity (as defined by CTCAE v4.0)

Other Outcome Measures:

1. To explore changes in the microbiome that is associated with normal tissue toxicities resulting from radiation [ Time Frame: 5 years ]
   To explore microbiome changes associated with normal tissue toxicities resulting from radiation
2. To compare blood count (CBC) measurements at different time points to assess impact of SBRT [ Time Frame: 5 years ]
   To collect complete blood count (CBC) measurements at pre-treatment, 1, 3 , 6 and 12 months post-treatment to assess impact of SBRT, if any, on baseline values

Eligibility Criteria

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Ages Eligible for Study:	19 Years to 99 Years (Adult, Senior)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Contacts

Contact: Sharanya Chandrasekhar, M.S.	212-746-7277	shc2043@med.cornell.edu
Contact: Christina Castro, B.S	212-746-2546	chc2071@med.cornell.edu

Locations

United States, New York
Weill Cornell Medicine	Recruiting
New York, New York, United States, 10065
Contact: Sharanya Chandrasekhar, M.S. 212-746-7277 shc2043@med.cornell.edu
Contact: Christina Castro, B.S. 212-746-2546 chc2071@med.cornell.edu
Principal Investigator: Josephine Kang, M.D.

Sponsors and Collaborators

Weill Medical College of Cornell University

Investigators

Principal Investigator:	Josephine Kang, M.D.	Weill Cornell Medicine - New York Presbyterian Hospital
Principal Investigator:	Silvia Formenti, M.D.	Weill Cornell Medicine - New York Presbyterian Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT02911922 History of Changes
Other Study ID Numbers:	1604017139
First Posted:	September 22, 2016
Last Update Posted:	August 22, 2017
Last Verified:	August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site	Neoplasms; Genital Diseases, Male; Prostatic Diseases