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

NCT02911922 | Terminated Results DMC

• 1 other identifier: 1604017139
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Measure the Effect of Treatment on Patients' Using Health Related Quality of Life Based on Expanded Prostate Cancer Index Composite Questionnaire

  1 year

• Number of Participants With Recurrence-free Survival

  1 year

• Comparing Several Parameters That Are Involved in Treatment Planning in Patients Randomized to Two Radiation Therapy Modalities.

  5 years

• Incidence of Patient-reported Toxicity (Late Toxicity) Based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4

  post RT to 1 year

Other Outcomes (2)

• Measuring Number of Participants Changes in the Microbiome That is Associated With Normal Tissue Toxicities Resulting From Radiation From Baseline to End of Treatment

  baseline, post radiation follow up

• Comparing Neutrophile:Lymphocyte Ratio (NLR) at Different Time Points to Assess Impact of SBRT in All the Participants

  1 month, 6 months, 1 year

Study Arms (2)

Endorectal balloon - Radiation therapy

EXPERIMENTAL

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; Radiation: Radiation therapy

Rectal spacer - Radiation therapy

EXPERIMENTAL

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; Radiation: Radiation therapy

Interventions

Endorectal Balloon DEVICE

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.

Endorectal balloon - Radiation therapy

Rectal Spacer DEVICE

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.

Rectal spacer - Radiation therapy

Radiation therapy RADIATION

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.

Endorectal balloon - Radiation therapy; Rectal spacer - Radiation therapy

Eligibility Criteria

• Age: 19 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Josephine Kang, M.D. Ph.D.
• Organization: Weill Cornell Medicine - New York Presbyterian Hospital

jok9106@med.cornell.edu

212-746-3607

Study Officials

• Josephine Kang, M.D.

  Weill Cornell Medicine - New York Presbyterian Hospital

  PRINCIPAL INVESTIGATOR

• Silvia Formenti, M.D.

  Weill Cornell Medicine - New York Presbyterian Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2016
• First Posted: September 22, 2016
• Study Start: September 1, 2016
• Primary Completion: April 17, 2018
• Study Completion: April 17, 2018
• Last Updated: April 29, 2019
• Results First Posted: April 29, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)