Clinical trial NCT01981707: F-choline PET in Early Response Assessment for Castration Resistant Prostatic Cancer
Official title: F-choline PET in Early Response Assessment for Castration Resistant Prostatic Cancer Treated by Abiraterone Acetate or Enzalutamide
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Castration-resistant Prostate Cancer
Keywords: castration-resistant prostate cancer
abiraterone acetate
enzalutamide
choline pet
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2013-11-11
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: Sensitivity and specificity of 6 weeks PET-CT performed on the response after 12 weeks of abiraterone acetate treatment or enzalutamide
timeFrame: 12 weeks
Secondary outcomes:
measure: Study of global survival and progression-free survival according to the results of baseline F-choline PET .
timeFrame: 24 weeks
measure: Study of global survival and progression-free survival at 12 weeks of treatment according to the results of 6 weeks treatment F-choline PET.
timeFrame: 12 weeks
measure: Comparison of Area Under the Curve receiver operating characteristic curve for maximum standardized uptake value (SUVmax) different values.
timeFrame: 12 and 24 weeks
measure: Study of global survival and progression-free survival at 24 weeks of treatment according to the results of 6 weeks treatment F-choline PET.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Clinique Universitaire d'Oncologie Médicale, CHU de Grenoble
city: Grenoble
country: France
facility: Clinique Universitaire de Médecine Nucléaire, CHU de Grenoble
city: Grenoble
country: France
facility: Service d'Oncologie Médicale, Institut Daniel Hollard, Groupement Hospitalier Mutualiste
Study officials:
affiliation: University Hospital, Grenoble
name: Jean-Philippe Vuillez, MD PHD
role: PRINCIPAL_INVESTIGATOR
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