Retrospective Evaluation of Commercial Spacers in Prostate Cancer Patients

Prostate Cancer Clinical Trial

— CLP-10095  

Official title:

Evaluation of Commercially Available Implantable Spacers, in Prostate Cancer Patients Undergoing Radiotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05354427
• Other study ID #: CLP-10095
• Status: Completed
• Start date: June 18, 2020
• Est. completion date: January 1, 2022

Study information

• Verified date: April 2022
• Source: BioProtect
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Assessment of efficacy and safety of implantable spacers when used to reduce the radiation dose delivered to the organs at risk in prostate cancer patients undergoing radiotherapy.

Description:

Multi-center, retrospective, observational study for assessment of rectal dose reduction following implantation of the BioProtect Balloon Implant System

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males at least 18 years of age, who have undergone radiation therapy with implantable spacers

Exclusion Criteria:

• Patients whose clinical and pathological data are not available.

• Patients have been histologically diagnosed with invasive adenocarcinoma that is extracapsular with posterior extension

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Observation
Assessment of rectal dosimetry change from pre-insertion to post-insertion in subjects with prostate cancer who have undergone radiotherapy with implantabale spacers.

Locations

Country	Name	City	State
Poland	Institute of Maria Sklodowska, Curie (MCMCC)	Warsaw
Portugal	Cuf Porto institution	Porto

Sponsors (1)

Lead Sponsor	Collaborator
BioProtect

Countries where clinical trial is conducted

Poland,  Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of adverse events throughout the treatment course and follow up period		3 months
Primary	Evaluation of Rectal radiation Dose	Dosimetry change to organs at risk in subjects with prostate cancer who have undergone radiotherapy with implantable spacers when compared to pre-implantation values.	1 month
Secondary	Prostate to rectum spacing	Measurement of prostate-rectum spacing	1 month