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

NCT01374087 | Terminated Phase 2 Results

• 2 other identifiers: A-92-52014-1772010-019158-41
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Prostate Cancer

Keywords

Recurrent Prostate Carcinoma; Brachytherapy; Triptorelin; Hormone Therapy

Outcome Measures

Primary Outcomes (1)

• Biochemical Failure-free Survival (BFFS)

  BFFS was determined by a prostate-specific antigen (PSA) increase of 2 nanograms per millilitre (ng/mL) or more in comparison with the pre-study nadir PSA and confirmed in the course of follow-up by a second value 3 weeks later or longer over the 5 year follow-up. Time to BFFS was defined from treatment initiation to the first time when PSA increase of 2 ng/mL was observed. As the study was prematurely terminated, no analyses were conducted. Data for BFFS are listed by subject for those individuals who reported biochemical failure. Time (in months) to biochemical failure is relative to the date of brachytherapy.

  Up to 5 years

Secondary Outcomes (6)

• Time to Progression

  Up to 5 years

• BFFS Percentage 5 Years From Treatment Initiation

  5 years

• Overall Survival

  5 years

• Number of Participants With Change in Total Serum Testosterone Levels From Baseline at 3, 6 and 12 Months

  Baseline and 3, 6 and 12 months

• Number of Participants With Change in Total Serum PSA Levels From Baseline at 3, 6 and 12 Months

  Baseline and 3, 6 and 12 months

Study Arms (2)

Brachytherapy + Triptorelin 22.5 mg

EXPERIMENTAL

Brachytherapy: Low or high dose rate. Triptorelin: A single, intramuscular injection (22.5 mg), preferably 2 months before brachytherapy.

Drug: Triptorelin 22.5 mg; Radiation: Brachytherapy

Brachytherapy

ACTIVE COMPARATOR

Brachytherapy: Low or high dose rate.

Radiation: Brachytherapy

Interventions

Triptorelin 22.5 mg DRUG

Triptorelin: A single, intramuscular injection (22.5 mg), preferably 2 months before brachytherapy.

Brachytherapy + Triptorelin 22.5 mg

Brachytherapy RADIATION

Brachytherapy: Low or high dose rate.

Brachytherapy; Brachytherapy + Triptorelin 22.5 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A history of prostate cancer (T1-T2-T3 N0 M0), confirmed through histopathology and initially treated with radiotherapy.
• Age ≤ 75 years.
• 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.
• The subject was required to be amenable to brachytherapy treatment.
• Adequate urinary function according to the questionnaire (IPSS ≤ 20 points).
• 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.
• Suitable liver function determined by: serum bilirubin \< 1.5 x Upper Normal Level (UNL), and alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 2.5xUNL.
• Suitable renal function determined by: serum creatinine \< 1.5 x UNL, or creatinine clearance ≥ 60 mL/min.
• The subject was required to be ≥ 18 years old.
• The subject had to give his written informed consent (personally signed and dated) before starting with any study-related procedure.

You may not qualify if:

• Evidence of metastatic disease.
• Previous evidence of hormone-resistant cancer.
• Lack of availability for performing regular follow-up.
• Subjects who were receiving or had received either luteinizing hormone-releasing hormone (LH-RH) agonists, or antagonists, over the previous 12 months.
• 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.
• Subjects with a significant co-existing disease or an active infection.
• Subjects who had been treated with investigational therapies within 4 weeks prior to the brachytherapy ± triptorelin treatment.
• Subjects with known hypersensitivity to triptorelin, LH-RH, other LH-RH-analogous agonists, or any excipients in triptorelin 22.5 mg.
• 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.

Sponsors & Collaborators

• Ipsen: lead

Study Sites (11)

Fundación IMOR

Barcelona, Spain

Location

H. de la Santa Creu i Sant Pau

Barcelona, Spain

Location

ICO Institut Català d'Oncologia-Hospitalet

L'Hospitalet de Llobregat, Spain

Location

H. Ramón y Cajal

Madrid, Spain

Location

H. Sanchinarro

Madrid, Spain

Location

H. Carlos Haya

Málaga, Spain

Location

Complejo Hospitalario de Navarra

Pamplona, Spain

Location

Instituto Oncológico

San Sebastián, Spain

Location

H. Universitario Marqués de Valdecilla

Santander, Spain

Location

IVO Instituto Valenciano de Oncología

Valencia, Spain

Location

H. Do Meixoeiro

Vigo, Spain

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Triptorelin Pamoate; Brachytherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Radiotherapy; Therapeutics

Limitations and Caveats

The study was prematurely stopped due to slow enrolment and all subjects were withdrawn following study termination in December 2014. Due to the small number of participating subjects very limited analyses were performed for the efficacy endpoints.

Results Point of Contact

• Title: Medical Director
• Organization: Ipsen

clinical.trials@ipsen.com

use email

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2011
• First Posted: June 15, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 18, 2019
• Results First Posted: February 23, 2017

Record last verified: 2019-09

Locations

ES (11)