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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


Phase 2
18 Years
75 Years
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Biochemical failure-free survival (BFFS)

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Guillermo De la Cruz SugraƱas, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Ipsen

Authority:

Spain: Agencia EspaƱola de Medicamentos y Productos Sanitarios

Study ID:

A-92-52014-177

NCT ID:

NCT01374087

Start Date:

November 2011

Completion Date:

July 2018

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms
  • Recurrence

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