NCT05354427

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 18, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 29, 2022

Completed
Last Updated

September 16, 2025

Status Verified

April 1, 2022

Enrollment Period

1.5 years

First QC Date

April 26, 2022

Last Update Submit

September 15, 2025

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Prostate to rectum spacing

    1 month

Other Outcomes (1)

  • Incidence of adverse events throughout the treatment course and follow up period

    3 months

Interventions

ObservationOTHER

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

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsProstate Cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Prostate Cancer

You may qualify if:

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

You may not qualify if:

  • Patients whose clinical and pathological data are not available.
  • Patients have been histologically diagnosed with invasive adenocarcinoma that is extracapsular with posterior extension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institute of Maria Skłodowska, Curie (MCMCC)

Warsaw, Poland

Location

Cuf Porto institution

Porto, Portugal

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2022

First Posted

April 29, 2022

Study Start

June 18, 2020

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

September 16, 2025

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)PT(1)