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

• Status: Terminated
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The primary objective of the study was to compare the efficacy of brachytherapy versus brachytherapy + triptorelin 22.5 mg (single injection) in subjects with recurrence of prostate cancer previously treated with radiotherapy. Efficacy was to be assessed by biochemical failure-free survival (BFFS) curves from treatment initiation up to 5 years.

Secondary objectives included comparing the following: the differences in time to progression of subjects receiving brachytherapy + triptorelin 22.5 mg versus subjects receiving brachytherapy only, the BFFS percentages between both treatment groups at 5 years from treatment initiation, overall survival between both treatment groups, total testosterone changes (from baseline visit up to 12 months) and Prostate Specific Antigen (PSA) levels (from baseline visit up to 60 months of treatment) between both treatment groups, quality of life (QoL) modifications (Spanish version of the Expanded Prostate Cancer Index Composite (EPIC) questionnaire) between the baseline score and the rest of measurements, and to compare safety between both treatment groups.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen
• Treatments: Triptorelin Pamoate

Criteria

Inclusion Criteria:

1. A history of prostate cancer (T1-T2-T3 N0 M0), confirmed through histopathology and initially treated with radiotherapy.

2. Age ≤ 75 years.

3. 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.

4. Late local recurrence of the initial prostate cancer. A recurrence is late when it appears after longer than 18 months post-radiotherapy.

5. PSA < 10 ng/mL at the time of recurrence.

6. The subject was required to be amenable to brachytherapy treatment.

7. Adequate urinary function according to the questionnaire (IPSS ≤ 20 points).

8. Suitable bone marrow function, determined by:

• Haemoglobin > 10 g/dL.

• Neutrophil count > 1.5 x 10^9/L.

• Platelet count > 100 x 10^9/L.

9. Suitable liver function determined by: serum bilirubin < 1.5 x Upper Normal Level (UNL), and alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 2.5xUNL.

10. Suitable renal function determined by: serum creatinine < 1.5 x UNL, or creatinine clearance ≥ 60 mL/min.

11. The subject was required to be ≥ 18 years old.

12. The subject had to give his written informed consent (personally signed and dated) before starting with any study-related procedure.

13. Life expectancy > 5 years.

Exclusion Criteria:

1. Evidence of metastatic disease.

2. Previous evidence of hormone-resistant cancer.

3. Lack of availability for performing regular follow-up.

4. Subjects who were receiving or had received either luteinizing hormone-releasing hormone (LH-RH) agonists, or antagonists, over the previous 12 months.

5. Subjects who had been on treatment with other hormone therapies, including antagonists, megestrol acetate, finasteride, dutasteride, any herbaceous product known to reduce the PSA levels, or any systemic corticosteroid, over the previous 4 weeks.

6. Subjects who had previously undergone a radiotherapy treatment that was completed within 18 months of inclusion.

7. Subjects with pre-existing heart failure (New York Heart Association class III or IV), or with a myocardial infarction within 6 months of inclusion.

8. Subjects with a significant co-existing disease or an active infection.

9. Subjects who had been treated with investigational therapies within 4 weeks prior to the brachytherapy ± triptorelin treatment.

10. Subjects with known hypersensitivity to triptorelin, LH-RH, other LH-RH-analogous agonists, or any excipients in triptorelin 22.5 mg.

11. Subjects with a mental condition that prevented them from understanding the nature, the scope and the potential consequences of this study, and/or subjects who showed an uncooperative attitude.