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

NCT ID: NCT01981707

Last Updated: 2016-04-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2016-03-31

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.

Conditions

Castration-resistant Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

F-Choline-PET

Intervention Type: DEVICE

Interventions

F-Choline-PET

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Philippe Vuillez, MD PHD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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, , France

Countries

France

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Other Identifiers

2013-003058-25

Identifier Type: -

Identifier Source: org_study_id