Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

F-choline PET in Early Response Assessment for Castration Resistant Prostatic Cancer (PRECHOL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01981707
Recruitment Status : Terminated (enrollment default)
First Posted : November 11, 2013
Last Update Posted : April 28, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:

Until today no current diagnostic tool exists to identify an early objective response when patients with castration-resistant prostate cancer were treated by abiraterone acetate or enzalutamide. According to the Prostate Cancer Working Group, the investigators have to wait 12 weeks before the first evaluation. To know soon that the treatment is effective will be decisive for the oncologist, even more in palliative situation where second effects can't be imposed to patients.

In post-docetaxel, the F-choline PET-CT could be used to assess the response of this new therapy. Moreover, the investigators suppose that we can assess an early stage if there is an objective therapeutic response, at 6 weeks of treatment, in order to avoid unnecessarily and expansive treatment.

The aim of this study is to assess if it is possible to determine early (6 weeks of treatment)if a F-choline PET-CT could predict the response to abiraterone acetate or enzalutamide in post-docetaxel.


Condition or disease Intervention/treatment Phase
Castration-resistant Prostate Cancer Device: F-Choline-PET Phase 2 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: F-choline PET in Early Response Assessment for Castration Resistant Prostatic Cancer Treated by Abiraterone Acetate or Enzalutamide
Study Start Date : December 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: F-Choline PET
The F-Choline-PET will be performed before and at 6 weeks of the beginning of treatment by abiraterone acetate or enzalutamide.
Device: F-Choline-PET



Primary Outcome Measures :
  1. Sensitivity and specificity of 6 weeks PET-CT performed on the response after 12 weeks of abiraterone acetate treatment or enzalutamide [ Time Frame: 12 weeks ]
    A centralized review will be carried out by 2 independent reviewers. The gold-standard to evaluate tumoral response to abiraterone acetate or enzalutamide will be the pain, the Prostate Specific Antigen rate, and imagery at 3 months according to prostate cancer working group.


Secondary Outcome Measures :
  1. Study of global survival and progression-free survival according to the results of baseline F-choline PET . [ Time Frame: 24 weeks ]
  2. Study of global survival and progression-free survival at 12 weeks of treatment according to the results of 6 weeks treatment F-choline PET. [ Time Frame: 12 weeks ]
  3. Comparison of Area Under the Curve receiver operating characteristic curve for maximum standardized uptake value (SUVmax) different values. [ Time Frame: 12 and 24 weeks ]
  4. Study of global survival and progression-free survival at 24 weeks of treatment according to the results of 6 weeks treatment F-choline PET. [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Eastern Cooperative Oncology Group (ECOG)performance status score of 2 or less
  • Histologically or cytologically confirmed adenocarcinoma prostate cancer without neuroendocrine component (component with minority neuroendocrine) or small cell, or neuroendocrine cells or small minority component prostate who underwent surgical or medical castration
  • Disease progression during or after a docetaxel-based chemotherapy
  • serum testosterone level of 50 ng per deciliter or less (≤2.0 nmol per liter)
  • Biologic criteria :
  • platelets ≥ 100 000/μl,
  • Creatinine <1.5 x upper limit or creatinine clearance ≥ 60 ml / min,
  • Serum potassium ≥ 3.5 mmol / l,
  • Bilirubin <1.5 x upper limit of normal (ULN)
  • hemoglobin ≥ 9.0 g / dl without any transfusion.

Exclusion Criteria:

  • abnormal aminotransferase levels (levels of aspartate aminotransferase or alanine aminotransferase that were ≥2.5 times the upper level of the normal range; patients with known liver metastasis who had levels of aspartate aminotransferase or alanine aminotransferase that were ≤5 times the upper level of the normal range were eligible to participate
  • previous therapy with ketoconazole
  • serious coexisting nonmalignant disease :
  • active or symptomatic viral hepatitis or chronic liver disease,
  • uncontrolled hypertension,
  • a history of pituitary or adrenal dysfunction,
  • clinically significant heart disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01981707


Locations
Layout table for location information
France
Clinique Universitaire d'Oncologie Médicale, CHU de Grenoble
Grenoble, France, 38 000
Clinique Universitaire de Médecine Nucléaire, CHU de Grenoble
Grenoble, France, 38 000
Service d'Oncologie Médicale, Institut Daniel Hollard, Groupement Hospitalier Mutualiste
Grenoble, France, 38 000
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Layout table for investigator information
Principal Investigator: Jean-Philippe Vuillez, MD PHD University Hospital, Grenoble
Publications:
Guide pour la rédaction de protocoles pour la tomographie par émission de positons (TEP) à la [18F]-Fluorocholine ([18F]-FCH). Médecine Nucléaire. 2012;36(6):353-9.
IRSN. Doses délivrées au patient en scannographie et en radiologie conventionelle - Résultats d'une enquête multicentrique en secteur public. Rapport DRPH/SER N°2010-12. 2010.

Layout table for additonal information
Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01981707    
Other Study ID Numbers: 2013-003058-25
First Posted: November 11, 2013    Key Record Dates
Last Update Posted: April 28, 2016
Last Verified: April 2016
Keywords provided by University Hospital, Grenoble:
castration-resistant prostate cancer
abiraterone acetate
enzalutamide
choline pet
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Prostatic Neoplasms, Castration-Resistant
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents