NCT05423431

Brief Summary

Dosimetry efficacy of the hydrogel spacer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

November 9, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
Last Updated

June 24, 2022

Status Verified

June 1, 2022

Enrollment Period

8 months

First QC Date

June 14, 2022

Last Update Submit

June 19, 2022

Conditions

Prostate Cancer

Keywords

ProstateProstate CancerSpacerPerirectal spacer

Outcome Measures

Primary Outcomes (1)

  • Dosimetry Changes

    Assessment of rectal radiation exposure as compared between rectal dose volume histograms calculated for pre and post hydrogel injection

    1 Month

Secondary Outcomes (1)

  • Prostate to rectum spacing

    1 Month

Study Arms (1)

Radiation with Hydrogel Spacer

Males at least 18 years of age, who underwent radiation therapy with a hydrogel spacer in place.

Other: Observation

Interventions

ObservationOTHER

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

Radiation with Hydrogel Spacer

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale
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
  • Undergone external beam or brachy radiation therapy with a hydrogel spacer in place

You may not qualify if:

  • Clinical and pathological data are not available
  • Invasive adenocarcinoma that is extracapsular and demonstrates posterior extension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Advanced Radiation Centers of New York ("ARC")

Lake Success, New York, 111042, United States

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

June 14, 2022

First Posted

June 21, 2022

Study Start

November 9, 2020

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

June 24, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)