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

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

balloon implant

Balloon implantation

About this trial

This is an interventional prevention trial for Prostate Cancer focused on measuring Prostate, cancer, radiation, biodegradable implantable balloon, intrarectal balloon

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Intra-operative exclusion criteria:

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.

Sites / Locations

Virginia Commonwealth University School of Medicine, Massey Cancer Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

balloon implantation

Arm Description

implantation of an absorbable perirectal spacer balloon

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Compare the rate of occurrence of rectal adverse events and implantation procedure related adverse events in balloon and control groups.

Full Information

NCT ID

NCT00918229

First Posted

June 9, 2009

Last Updated

November 13, 2018

Sponsor

BioProtect

1. Study Identification

Unique Protocol Identification Number

NCT00918229

Brief Title

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

Official Title

One-arm, Multi-center, International Prospective Study to Assess the Safety and Efficacy of BioProtect Biodegradable Implantable Balloon in Prostate Cancer Subjects Undergoing Radiotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

BioProtect

4. Oversight

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

Prostate, cancer, radiation, biodegradable implantable balloon, intrarectal balloon

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

balloon implantation

Arm Type

Other

Arm Description

implantation of an absorbable perirectal spacer balloon

Intervention Type

Device

Intervention Name(s)

balloon implant

Intervention Description

Absorbable perirectal spacer implantation

Intervention Type

Procedure

Intervention Name(s)

Balloon implantation

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

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

Description

Compare the rate of occurrence of rectal adverse events and implantation procedure related adverse events in balloon and control groups.

Time Frame

6 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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 Intra-operative exclusion criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yossi Muncher, Dr.

Organizational Affiliation

BioProtect

Official's Role

Study Director

Facility Information:

Facility Name

Virginia Commonwealth University School of Medicine, Massey Cancer Center

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298-0058

Country

United States

12. IPD Sharing Statement

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

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