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

Castration-resistant Prostate Cancer Clinical Trial

— PRECHOL  

Official title:

F-choline PET in Early Response Assessment for Castration Resistant Prostatic Cancer Treated by Abiraterone Acetate or Enzalutamide

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01981707
• Other study ID #: 2013-003058-25
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: August 1, 2013
• Last updated: April 27, 2016
• Start date: December 2013
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Castration-resistant Prostate Cancer
• Prostatic Neoplasms
• Prostatic Neoplasms, Castration-Resistant

Intervention

Device:
• F-Choline-PET

Locations

Country	Name	City	State
France	Clinique Universitaire d'Oncologie Médicale, CHU de Grenoble	Grenoble
France	Clinique Universitaire de Médecine Nucléaire, CHU de Grenoble	Grenoble
France	Service d'Oncologie Médicale, Institut Daniel Hollard, Groupement Hospitalier Mutualiste	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (27)

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of 6 weeks PET-CT performed on the response after 12 weeks of abiraterone acetate treatment or enzalutamide	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.	12 weeks	No
Secondary	Study of global survival and progression-free survival according to the results of baseline F-choline PET .		24 weeks	No
Secondary	Study of global survival and progression-free survival at 12 weeks of treatment according to the results of 6 weeks treatment F-choline PET.		12 weeks	No
Secondary	Comparison of Area Under the Curve receiver operating characteristic curve for maximum standardized uptake value (SUVmax) different values.		12 and 24 weeks	No
Secondary	Study of global survival and progression-free survival at 24 weeks of treatment according to the results of 6 weeks treatment F-choline PET.		24 weeks	No