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Trial record 1 of 1 for:    Randomized trial of image -guided stereotactic radiation therapy (IG-SRT) in prostate cancer
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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
Results First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Tracking Information
First Submitted Date  ICMJE September 19, 2016
First Posted Date  ICMJE September 22, 2016
Results First Submitted Date  ICMJE February 12, 2019
Results First Posted Date  ICMJE April 29, 2019
Last Update Posted Date April 29, 2019
Study Start Date  ICMJE September 2016
Actual Primary Completion Date April 17, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2019)
Incidence of Patient-reported Acute Toxicity Based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4 [ Time Frame: Baseline to 1 year ]
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).
Original Primary Outcome Measures  ICMJE
 (submitted: September 20, 2016)
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)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2019)
  • Measure the Effect of Treatment on Patients' Using Health Related Quality of Life Based on Expanded Prostate Cancer Index Composite Questionnaire [ Time Frame: 1 year ]
    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.
  • Number of Participants With Recurrence-free Survival [ Time Frame: 1 year ]
    1 year
  • Comparing Several Parameters That Are Involved in Treatment Planning in Patients Randomized to Two Radiation Therapy Modalities. [ 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
  • Incidence of Patient-reported Toxicity (Late Toxicity) Based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4 [ Time Frame: post RT to 1 year ]
    To compare late toxicity (as defined by CTCAE v4.0). Late toxicities are toxicities that occur greater than 3 months after radiation therapy completion.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2016)
  • 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)
Current Other Pre-specified Outcome Measures
 (submitted: April 26, 2019)
  • Measuring Number of Participants Changes in the Microbiome That is Associated With Normal Tissue Toxicities Resulting From Radiation From Baseline to End of Treatment [ Time Frame: baseline, post radiation follow up ]
    To explore microbiome changes associated with normal tissue toxicities resulting from radiation
  • Comparing Neutrophile:Lymphocyte Ratio (NLR) at Different Time Points to Assess Impact of SBRT in All the Participants [ Time Frame: 1 month, 6 months, 1 year ]
    Comparing NLR ratio at different timepoints to assess the impact of radiation therapy on patients. A neutrophil:lymphocyte ratio (NLR) > 4 at time radiotherapy predicts for significantly worse prognosis, when compared to NLR < 4.
Original Other Pre-specified Outcome Measures
 (submitted: September 20, 2016)
  • 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
 
Descriptive Information
Brief Title  ICMJE Randomized Trial of Image -Guided Stereotactic Radiation Therapy (IG-SRT) in Prostate Cancer
Official Title  ICMJE Randomized Trial of Image -Guided Stereotactic Radiation Therapy (IG-SRT) in Prostate Cancer
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • 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.

  • 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.
Study Arms  ICMJE
  • 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.

    Interventions:
    • Device: Endorectal Balloon
    • 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.

    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.

    Interventions:
    • Device: Rectal Spacer
    • Radiation: Radiation therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 26, 2019)
1
Original Estimated Enrollment  ICMJE
 (submitted: September 20, 2016)
40
Actual Study Completion Date  ICMJE April 17, 2018
Actual Primary Completion Date April 17, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 19 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02911922
Other Study ID Numbers  ICMJE 1604017139
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Weill Medical College of Cornell University
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Weill Medical College of Cornell University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP