Study to Assess the Efficacy of Brachytherapy With or Without Hormone Therapy, Using Triptorelin 22.5mg in Patients With Recurrence of Prostate Cancer (ANABRAQ)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Ipsen
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01374087
First received: June 14, 2011
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

The purpose of the protocol, is to compare the efficacy of brachytherapy versus brachytherapy plus triptorelin 22.5 mg (single injection) in patients with recurrence of prostate cancer previously treated with radiotherapy.


Condition Intervention Phase
Prostate Cancer
Other: Brachytherapy + Decapeptyl® SR 22.5mg Triptorelin
Radiation: Brachytherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Proof-of-concept Multicentre, Prospective, Randomised, Open-label and Parallel Group Clinical Trial to Assess the Efficacy of Brachytherapy With or Without Hormone Therapy, Using Triptorelin 22.5 mg Six-monthly in Patients With Recurrence of Prostate Cancer Previously Treated With Radiotherapy

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Biochemical failure-free survival (BFFS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • BFFS percentage [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Overall survival (OS) (defined as the time from randomisation to death due to any cause) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Change in total testosterone [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Median time to prostate-specific antigen (PSA) progression [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Quality of Life modifications (Spanish version of the Expanded Prostate Cancer Index Composite [EPIC] questionnaire) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 96
Study Start Date: November 2011
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brachytherapy + Decapeptyl® SR 22.5mg Triptorelin Other: Brachytherapy + Decapeptyl® SR 22.5mg Triptorelin
Brachytherapy: Low dose rate or high dose rate. Triptorelin: Single injection (22.5 mg), intramuscular injection, preferably 2 months before brachytherapy.
Active Comparator: Brachytherapy Radiation: Brachytherapy
Brachytherapy: Low dose rate or high dose rate.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A history of prostate cancer (T1-T2-T3 N0 M0), confirmed through histopathology and initially treated with radiotherapy.
  • Biochemical failure due to Phoenix criteria (nadir + 2) and local recurrence of the initial prostate cancer, confirmed by prostate biopsy, with neither regional involvement nor distant metastases.
  • Late local recurrence of the initial prostate cancer. A recurrence is late when it appears after longer than 18 months post- radiotherapy.
  • PSA < 10 ng/ml at the time of recurrence.

Exclusion Criteria:

  • Evidence of metastatic disease.
  • Previous evidence of hormone-resistant cancer.
  • Patients currently receiving or having received either Luteinizing hormone-releasing hormone (LH-RH) agonists, or antagonists, over the last 12 months.
  • Patients with known hypersensitivity to triptorelin, LH-RH, other LH-RH-analogous agonists, or any of triptorelin 22.5 mg's excipients.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01374087

Contacts
Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com

Locations
Spain
H. de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain
Fundación IMOR Recruiting
Barcelona, Spain
H. Oncológico de Galicia Withdrawn
Coruña, Spain
ICO Institut Català d'Oncologia-Hospitalet Recruiting
Hospitalet de Llobregat, Spain
H. Ramón y Cajal Recruiting
Madrid, Spain
H. Sanchinarro Recruiting
Madrid, Spain
H. Virgen de la Victoria Withdrawn
Málaga, Spain
H. Carlos Haya Recruiting
Málaga, Spain
H. Central de Asturias Withdrawn
Oviedo, Spain
Complejo Hospitalario de Navarra Recruiting
Pamplona, Spain
Instituto Oncológico Recruiting
San Sebastián, Spain
H. Universitario Marqués de Valdecilla Recruiting
Santander, Spain
IVO Instituto Valenciano de Oncología Recruiting
Valencia, Spain
H. Do Meixoeiro Recruiting
Vigo, Spain
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Guillermo De la Cruz Sugrañas, M.D. Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01374087     History of Changes
Other Study ID Numbers: A-92-52014-177
Study First Received: June 14, 2011
Last Updated: July 28, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Prostatic Neoplasms
Recurrence
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Disease Attributes
Pathologic Processes
Triptorelin Pamoate
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 18, 2014