NCT02858128

Brief Summary

The purpose of this study is to determine the effectiveness of whole-body diffusion-weighted magnetic resonance imaging (WB-DW- MRI) in detecting metastases by comparing the results with those from choline-positron emission tomography-computed tomography (choline-PET/CT) in patients with metastatic/oligometastatic prostate cancer. Patients with this disease profile who could benefit from treatment with stereotactic body radiation therapy (SBRT) were selected and their responses to these techniques were rated.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2014

Shorter than P25 for all trials

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

October 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 8, 2016

Completed
Last Updated

August 9, 2016

Status Verified

August 1, 2016

Enrollment Period

5 months

First QC Date

August 3, 2016

Last Update Submit

August 6, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • effectiveness of whole-body diffusion-weighted magnetic resonance imaging (WB-DW- MRI) in detecting metastases

    2 years

Interventions

Choline-PET/CT versus NMRscan comparative study

Eligibility Criteria

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

46 consecutive patients given a diagnosis of prostate cancer by the Radiation Oncology Department of our center, between October 2014 and March 2015 who met the established inclusion criteria: a histological diagnosis of prostate cancer, and after treatment of the primary disease, a diagnosis of biochemical relapse and no metastases or oligometastatic stage (less than 5 lesions) in conventional diagnostic images (bone scintigraphy, chest-abdominal and pelvic CT and pelvic MRI).

You may qualify if:

  • Prostate cancer histologic diagnostic after one treatment
  • o less lessions
  • Asimptomatic lessions
  • Informed Consent Form signed

You may not qualify if:

  • Not capability to perform NMR os CT/PET scans

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Conde-Moreno AJ, Herrando-Parreno G, Muelas-Soria R, Ferrer-Rebolleda J, Broseta-Torres R, Cozar-Santiago MP, Garcia-Pinon F, Ferrer-Albiach C. Whole-body diffusion-weighted magnetic resonance imaging (WB-DW-MRI) vs choline-positron emission tomography-computed tomography (choline-PET/CT) for selecting treatments in recurrent prostate cancer. Clin Transl Oncol. 2017 May;19(5):553-561. doi: 10.1007/s12094-016-1563-4. Epub 2016 Oct 31.

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Antonio J Conde Moreno, MD PhD

    Hospital Provincial de Castellon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

August 3, 2016

First Posted

August 8, 2016

Study Start

October 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

August 9, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share