N/A N=7 Prevention

Evaluation of the Safety and Efficacy of the BioProtect Balloon in Prostate Cancer Subjects Undergoing Radiotherapy

Prostate Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00462124 ↗

Enrolled (actual)

Serious AEs

14.3%

Results posted

Aug 2019

Primary outcome: Primary: Safety of Balloon Implant — 0 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Absorbable perirectal spacer (Device)
Age: Pediatric, Adult, Older Adult
Sex: Male
Sponsor: BioProtect
Primary completion: Mar 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Safety of Balloon Implant	—	—
SECONDARY Efficacy Will be Measured in Terms of: Number of Participants With a Reduction in Radiation to the Rectum	7	—

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 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.

Eligibility Criteria

Inclusion Criteria

Male aged ≤80.
Men with child producing potential (that are not sterile) must accept using adequate contraceptive throughout the radiotherapy phase and for at least 3 months after completion of the radiotherapy phase when ever they have heterosexual intercourse.
Diagnosed prostate cancer not spread outside the capsule (T1 and T2).
Subject is scheduled for localized prostate XRT treatments.
Zubrod performance status 0-1; or Karnofsy >80.
Pre-randomization serum PSA lower than 25 (obtained prior to any LHRH or antiandrogen therapy); or Kattan nomogram less than 15 %.
Subject able to comprehend and give informed consent for participation in this study.
Probability of lymph node involvement based on Kattan nomogram less than 15 %.
Normal blood CBC and biochemistry up to two weeks before screening as follow:
Normal CBC
Absolute neutrophil count (ANC) ≥ 1, 800 cells/mm3
Platelets ≥ 100,000 cells/mm3
Hemoglobin ≥ 10.0 g/dl
Adequate renal function, with serum creatinine ≤ 2.0 mg/dl
Adequate liver function, with serum bilirubin 2.0 mg/dl).
Inflammatory diseases of the perineal skin.
Urinary tract infection or acute or chronic prostatitis.
Active inflammatory bowel disease.
Rectal carcinoma.
Subjects after anterior resection of rectum or after rectal amputation.
Known cognitive disorder.
Concurrent participation in any other clinical study.
Physician objection.

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Data sourced from ClinicalTrials.gov (NCT00462124). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.