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

Grenoble Alpes University Hospital Center (CHU)

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Castration-resistant Prostate Cancer

Treatments: Device: F-Choline-PET

Study type: Interventional

Funder types: Other

Identifiers

NCT01981707

2013-003058-25

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

F-Choline PET

Experimental group

Description:

The F-Choline-PET will be performed before and at 6 weeks of the beginning of treatment by abiraterone acetate or enzalutamide.

Treatment:

Device: F-Choline-PET