NCT03284151

Brief Summary

Focused stereotactic radiation treatment of localized prostatic adenocarcinoma. in order to quantify the delay between the focused treatment and the salvage procedure.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2015

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 15, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

June 22, 2022

Status Verified

June 1, 2022

Enrollment Period

5 years

First QC Date

September 7, 2017

Last Update Submit

June 20, 2022

Conditions

Prostate Cancer

Keywords

prostate cancergood prognosisfocused treatmentCyberknife

Outcome Measures

Primary Outcomes (1)

  • Delay between the initial diagnosis and date of salvage treatment

    Delay between the initial diagnosis and date of salvage treatment

    through study completion, up to 36 months

Secondary Outcomes (5)

  • PSA evaluation

    3, 6, 12, 18, 24, 30, 36 months

  • Birads score evaluation

    12, 24, 36 months

  • Acute and late toxicity

    3, 6, 12, 18, 24, 30, 36 months

  • IPSS evaluation

    12, 24, 36 months

  • IIEF5 evaluation

    12, 24, 36 months

Interventions

CyberknifeRADIATION

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Prostatic adenocarcinoma Capra≤2

You may qualify if:

  • Prostatic adenocarcinoma of Capra score≤2 invading no more than two adjacent of the 12 prostatic zones. Lesions\>3mm. Maximal urinary flow rate ≥ 10ml/s, mean flow rate ≥ 5ml/s, post micturation volume ≤80ml, IPSS score ≤15.

You may not qualify if:

  • systemic disease, ulcerative hemorrhagic ulcer or Crohn diseases, bladder neck stenosis, urethral implants, transurethral prostatectomy (TURP), any recurrent prostatitis within the last 3 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Francois Baclesse

Esch-sur-Alzette, 4005, Luxembourg

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Philippe Nickers, MD, PhD

    Centre Francois Baclesse

    STUDY CHAIR

  • Michel Untereiner, MD

    Centre Francois Baclesse

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2017

First Posted

September 15, 2017

Study Start

January 1, 2015

Primary Completion

January 1, 2020

Study Completion

January 1, 2023

Last Updated

June 22, 2022

Record last verified: 2022-06

Locations

LU(1)