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

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ClinicalTrials.gov Identifier: NCT02911922

Recruitment Status : Terminated (Lack of patient accruals.)

First Posted : September 22, 2016

Last Update Posted : August 13, 2018

Sponsor:

Information provided by (Responsible Party):

Weill Medical College of Cornell University

Study Description

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.

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.

Study Design


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
Actual Primary Completion Date :	April 17, 2018
Actual Study Completion Date :	April 17, 2018

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Prostate cancer

MedlinePlus related topics: Prostate Cancer

U.S. FDA Resources

Arms and Interventions

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.

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.

Radiation: Radiation therapy

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.

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.

Radiation: Radiation therapy

Outcome Measures

Primary Outcome Measures :

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 :

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
To measure recurrence-free survival [ Time Frame: 5 years ]
To compare biochemical recurrence-free survival at 1, 2 and 5 years
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
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:

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
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

Information from the National Library of Medicine

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Ages Eligible for Study:	19 Years to 99 Years (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02911922

Locations


United States, New York
Weill Cornell Medicine
New York, New York, United States, 10065

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


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 Key Record Dates
Last Update Posted:	August 13, 2018
Last Verified:	August 2018
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

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