Pilot Study to Assess the Safety and Efficacy of BioProtect Balloon in Prostate Cancer Subjects

NCT ID: NCT00918229

Last Updated: 2018-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2011-05-31

Brief Summary

Primary Goal

The study's primary goal is to assess the safety of the BioProtect biodegradable balloon implant and implantation procedure, in prostate cancer subjects undergoing routine radiation therapy (XRT) treatment. Safety of the BioProtect device will be assessed by reporting adverse events.

Secondary Goal

The study's secondary goal is to evaluate the effectiveness of the BioProtect biodegradable balloon implant in prostate cancer subjects undergoing routine XRT treatment. Effectiveness will be assessed in terms of increased distance between anterior rectal wall and prostate and noticeable reduction of isodose to the rectum.

Detailed Description

Primary Endpoint Parameters

The incidence of unexpected serious adverse events related to BioProtect's SpaceGuard balloon implant and/or implantation procedure:

1. Serious Adverse Events related to the BioProtect balloon and/or implantation procedure were defined by the Clinical Trials.gov definition of a serious adverse event. Serious Adverse Events will be documented in Serious Adverse Event Form.

2. Adverse Events related to the BioProtect balloon and/or implantation procedure. Adverse Events were documented in Adverse Event Form.

3. Subjective discomfort related to the balloon and implantation procedure were assessed by a pain analogue scale.

Secondary Endpoint Parameters A 10% decrease or greater of the average rectal doses at V50 in at least 75% of the subjects after balloon implantation as compared to the doses at V50 before the balloon implantation. This was measured by routine Dose Volume Histogram (DVH) per local hospital practice and according to the instructions regarding anatomical landmarks delineated in this protocol.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

balloon implantation

implantation of an absorbable perirectal spacer balloon

Group Type: OTHER

balloon implant

Intervention Type: DEVICE

Absorbable perirectal spacer implantation

Balloon implantation

Intervention Type: PROCEDURE

Implantation of the balloon between the prostate and the anterior rectal wall

Interventions

balloon implant

Absorbable perirectal spacer implantation

Intervention Type: DEVICE

Balloon implantation

Implantation of the balloon between the prostate and the anterior rectal wall

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Adult male above 45 years old and less than 85.
• Diagnosed locally confined prostate cancer per hospital practice and definitions for local confined prostate cancer.
• Subject is scheduled for only localized prostate XRT treatments
• Zubrod performance status 0-1; or Karnofsy >80
• Blood CBC and biochemistry up to two weeks before screening demonstrating:

• Platelets ≥ 100,000 cells/mm3
• Hemoglobin ≥ 10.0 g/dl
• Normal values of electrolytes (sodium, potassium, calcium)
• Normal values of the PT, PTT and INR tests.
• Peak Uroflow rate ≥ 13ml/sec
• Residual Urine volume Test result < 150 ml
• Urinalysis (RBC, WBC) and urine culture
• Subject able to comprehend and give informed consent for participation in this study and are considered by the investigator to have good compliance for the study.

Exclusion Criteria

• Any prior prostate resection with a compliant prostate urethra as assessed by transrectal ultrasound (TRUS)
• Prior radical prostatectomy
• Prior cryosurgery or radiotherapy for prostate cancer, or other local therapy for prostate cancer
• Suspected extension of the prostate tumour toward the rectum as evidenced by acceptable imaging modalities used in the study site
• Prior surgical procedure involving peri-rectal and peri-prostatic area
• Prior radiotherapy to the pelvis, including brachytherapy at the same body organ
• Unstable angina
• Congestive heart failure (CHF) phase III or IV or CHF requiring hospitalization within the last 6 months prior to screening
• Transmural myocardial (MI) infarction within the last 6 months prior to screening
• Moderate to severe respiratory failure, hepatic failure or renal failure
• Acute infection requiring intravenous antibiotics at the time of screening
• Uncontrolled bleeding disorders
• Uncontrolled diabetes mellitus
• Known to be HIV positive or have any other immunosuppressive disorder
• Inflammatory diseases of the perineal skin
• Urinary tract infection or acute or chronic prostatitis
• Uncontrolled moderate to severe urinary disorders
• Active inflammatory bowel disease or moderate to severe gastrointestinal (GI) disorders
• Known or suspected rectal carcinoma
• Subjects after anterior resection of rectum or after rectal amputation
• Concurrent participation in any other clinical study

• Irregular findings by the implanting physician before or during implantation that to the best of the implanting physician may lead to prostate compliance leading to urinary retention or other such symptoms.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

BioProtect

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yossi Muncher, Dr.

Role: STUDY_DIRECTOR

BioProtect

Locations

Virginia Commonwealth University School of Medicine, Massey Cancer Center

Richmond, Virginia, United States

Countries

United States

Other Identifiers

BPI-01 (USA)

Identifier Type: -

Identifier Source: org_study_id