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

NCT00918229 | Completed Results FDA Device

• 1 other identifier: BPI-01 (USA)
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate; cancer; radiation; biodegradable implantable balloon; intrarectal balloon

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects Achieving a Reduction of at Least 25% of the Volume of the Rectum Receiving at Least 70 Gy.

  Evaluated in subjects with prostate cancer who underwent radiotherapy by means of IMRT and who received the ProSpace, with individual patient success defined as a reduction of at least 25% of the volume of the rectum receiving greater or equal to 70 Gy (VRectum70) when compared to pre-implantation values.

  6 months

Secondary Outcomes (1)

• Rate of Occurrence of Grade 2 or Greater Rectal Adverse Event or Procedure Related Adverse Events.

  6 months

Study Arms (1)

balloon implantation

OTHER

implantation of an absorbable perirectal spacer balloon

Device: balloon implant; Procedure: Balloon implantation

Interventions

balloon implant DEVICE

Absorbable perirectal spacer implantation

balloon implantation

Balloon implantation PROCEDURE

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

balloon implantation

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• BioProtect: lead

Study Sites (1)

Virginia Commonwealth University School of Medicine, Massey Cancer Center

Richmond, Virginia, 23298-0058, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Shaul Shohat
• Organization: BioProtect

Shaul@bioprotect.com

+972545423774

Study Officials

• Yossi Muncher, Dr.

  BioProtect

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2009
• First Posted: June 11, 2009
• Study Start: June 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: November 20, 2018
• Results First Posted: November 20, 2018

Record last verified: 2018-11

Locations

US (1)