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

Sponsor

University Hospital, Grenoble (Other)

Overall Status

Terminated

CT.gov ID

NCT01981707

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Dec 1, 2013

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Mar 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Sensitivity and specificity of 6 weeks PET-CT performed on the response after 12 weeks of abiraterone acetate treatment or enzalutamide [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

Study of global survival and progression-free survival according to the results of baseline F-choline PET . [24 weeks]
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]
Comparison of Area Under the Curve receiver operating characteristic curve for maximum standardized uptake value (SUVmax) different values. [12 and 24 weeks]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Clinique Universitaire d'Oncologie Médicale, CHU de Grenoble	Grenoble	France	38 000
2	Clinique Universitaire de Médecine Nucléaire, CHU de Grenoble	Grenoble	France	38 000
3	Service d'Oncologie Médicale, Institut Daniel Hollard, Groupement Hospitalier Mutualiste	Grenoble	France	38 000