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


N/A
45 Years
85 Years
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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.
Serious adverse event are defined as adverse requiring operation and/or associated with
prolongation of hospital stay. 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 will be documented in Adverse Event Form.

3. Subjective discomfort related to the balloon and implantation procedure will be
assessed by 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 will be measured by routine Dose Volume Histogram
(DVH) per local hospital practice and according to the instruction regarding anatomical
landmarks delineated in this protocol.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

The safety endpoint is incidence of complications related to BioProtect balloon implant and implantation procedure

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Yossi Muncher, Dr.

Investigator Role:

Study Director

Investigator Affiliation:

BioProtect

Authority:

United States: Food and Drug Administration

Study ID:

BPI-01 (USA)

NCT ID:

NCT00918229

Start Date:

June 2009

Completion Date:

May 2011

Related Keywords:

  • Prostate Cancer
  • Prostate
  • cancer
  • radiation
  • biodegradable implantable balloon
  • intrarectal balloon
  • Prostatic Neoplasms

Name

Location

Virginia Commonwealth University School of Medicine, Massey Cancer CenterRichmond, Virginia  23298-0058