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

NCT01981707 | Terminated Phase 2

• 1 other identifier: 2013-003058-25
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

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

Keywords

castration-resistant prostate cancer; abiraterone acetate; enzalutamide; choline pet

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

Study Arms (1)

F-Choline PET

EXPERIMENTAL

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

Interventions

F-Choline-PET DEVICE

F-Choline PET

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (3)

Clinique Universitaire d'Oncologie Médicale, CHU de Grenoble

Grenoble, 38 000, France

Location

Clinique Universitaire de Médecine Nucléaire, CHU de Grenoble

Grenoble, 38 000, France

Location

Service d'Oncologie Médicale, Institut Daniel Hollard, Groupement Hospitalier Mutualiste

Grenoble, 38 000, France

Location

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Study Officials

• Jean-Philippe Vuillez, MD PHD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2013
• First Posted: November 11, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2016
• Last Updated: April 28, 2016

Record last verified: 2016-04

Locations

FR (3)