NCT03604211

Brief Summary

Single-institution retrospective analysis for predictive factors of prostate cancer patients presenting with isolated or limited lymph node (LN) recurrence (1-3 lesions) on F-Ccholine PET-CT (CholPET) treated with SBRT between January 2010 and July 2015.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 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

January 1, 2010

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 27, 2018

Completed
Last Updated

August 17, 2018

Status Verified

August 1, 2018

Enrollment Period

5.5 years

First QC Date

July 19, 2018

Last Update Submit

August 15, 2018

Conditions

Prostate Cancer RecurrentProstate CancerLymph Node Metastases

Outcome Measures

Primary Outcomes (1)

  • time to biochemical recurrence

    time interval from SBRT until second PSA rise

    18 months

Secondary Outcomes (2)

  • biochemical response rate

    18 months

  • time interval between SBRT and ADT start

    18 months

Interventions

Cyberknife Radiation TherapyRADIATION

Stereotactic Radiotherapy of lymphnode recurrence after prostatectomy +/- salvage radiotherapy

Eligibility Criteria

Age18 Years - 85 Years
Sexmale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

single-Institution cohort of male patients 18-85 years of age, with recurrent prostate cancer after radical prostatectomy in 1-3 lymphnodes, prospectively registered in a local institutional database

You may qualify if:

  • histologically proven diagnosis of prostate cancer
  • Radical prostatectomy (± salvage radiotherapy)
  • PSA relapse (defined by two consecutive rising PSA values \>0.2 ug/l)
  • one to three lymphnodes positive on Choline-PET
  • no recurrence in prostatic bed on Choline-PET
  • WHO performance status of 0-1
  • no previous chemotherapy or ADT for prostate cancer.

You may not qualify if:

  • primary treatment for prostate cancer by RT or brachytherapy
  • bone (M1b) metastases
  • visceral (M1c) metastases
  • any symptomatic nodal lesion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Juergen Curschmann

Zurich, 8032, Switzerland

Location

MeSH Terms

Conditions

Prostatic NeoplasmsLymphatic Metastasis

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Daniel R Zwahlen, MD

    Kantonsspital Graubuenden

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

July 19, 2018

First Posted

July 27, 2018

Study Start

January 1, 2010

Primary Completion

July 1, 2015

Study Completion

July 1, 2018

Last Updated

August 17, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)