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Trial · Interventional

TerminatedPhase 2Results postedRegistry data

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

Short name ANABRAQ

NCTNCT01374087 (opens ClinicalTrials.gov in a new tab)Other idA-92-52014-177Other id2010-019158-41
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 2
Enrollment
32 participants (actual)
Sponsor
Ipsen · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

Spain

Start
Nov 2011
Primary completion
Dec 2014
Completion
Dec 2014
First posted
15 Jun 2011 (estimated)
Last update posted
18 Sept 2019
Conditions
Prostate Cancer

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20112012201320142015
  1. Ph 2

    ANABRAQ

    NCT01374087

    Nov 2011 to Dec 2014

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Triptorelin 22.5 mgDrug
  • BrachytherapyRadiation

Arms2

  • Experimental

    Brachytherapy + Triptorelin 22.5 mg

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

  • Active comparator

    Brachytherapy

    Brachytherapy: Low or high dose rate.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Biochemical Failure-free Survival (BFFS)

    Time frame · Up to 5 years

    Registry description

    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.

Secondary outcomes(6)

  1. Time to Progression

    Time frame · Up to 5 years

    Registry description

    Time to progression (in months) was measured from the informed consent date to the date of first event occurrence. Progression was defined as either: death from all causes or disease progression (defined as PSA increased by 2 ng/mL as compared to the pre-trial nadir PSA, confirmed during follow-up by a second value after 3 or more weeks, or the diagnosis of a new clinical recurrence of their prostate cancer (metastasis, new injury, etc.)). As the study was prematurely terminated, no analyses were conducted. Data for time to progression are listed by subject for those individuals who reported progression.

  2. BFFS Percentage 5 Years From Treatment Initiation

    Time frame · 5 years

    Registry description

    A subject had a biochemical failure if there was an increase of PSA of 2 ng/mL or more in comparison with the pre-study nadir PSA confirmed in the course of follow-up by a second value after 3 or more weeks or with diagnosis of a new clinical recurrence of their prostate cancer over the 5 year follow-up.

  3. Overall Survival

    Time frame · 5 years

    Registry description

    Overall survival was defined as the time in months from diagnosis (biopsy date for local recurrence) to death due to any cause, the last visit or the loss to follow-up.

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

    Time frame · Baseline and 3, 6 and 12 months

    Registry description

    Blood samples were drawn for serum testosterone at baseline (Visit 1) and then at 3, 6 and 12 months. Changes from baseline in total serum testosterone levels in relation to the normal parameter ranges are indicated. WNR = Within Normal Range, BNR= Below Normal Range and ANR = Above Normal Range.

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

    Time frame · Baseline and 3, 6 and 12 months

    Registry description

    Blood samples were drawn for serum PSA at baseline (Visit 1) and at 3, 6 and 12 months. Changes from baseline in total serum PSA levels in relation to the normal parameter ranges are indicated. WNR = Within Normal Range, BNR= Below Normal Range and ANR = Above Normal Range.

  6. Change in Quality of Life (QoL) Modifications (Spanish Version of the Expanded Prostate Cancer Index Composite (EPIC) Questionnaire) From Baseline at 5 Years

    Time frame · Baseline and 5 years.

    Registry description

    EPIC assessed the disease-specific aspects of prostate cancer and its therapies and comprised four summary domains (Urinary, Bowel, Sexual and Hormonal). Factor analysis supported dividing the Urinary Domain Summary Score into two different Incontinence and Irritative/Obstructive subscales. In addition, each Domain Summary Score had measurable Function Subscale and Bother Subscale components. Response options for each EPIC item formed a Likert scale, and multi-item scale scores were transformed linearly to a 0-100 scale, with higher scores representing better Health-Related QoL.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Up to 5 years

Biochemical Failure-free Survival (BFFS)

GroupValue (Months)
Brachytherapy5.2
Brachytherapy + Triptorelin 22.5 mgNA
Secondary and other outcome results(6)
Secondary outcomeNumber· Up to 5 years

Time to Progression

GroupValue (Months)
Brachytherapy6.7
Brachytherapy + Triptorelin 22.5 mgNA
Secondary outcome· 5 years

BFFS Percentage 5 Years From Treatment Initiation

GroupValue
Brachytherapynot posted
Brachytherapy + Triptorelin 22.5 mgnot posted
Secondary outcome· 5 years

Overall Survival

GroupValue
Brachytherapynot posted
Brachytherapy + Triptorelin 22.5 mgnot posted
Secondary outcomeCount of participants· Baseline and 3, 6 and 12 months

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

GroupValue (Participants)
Brachytherapy6
Brachytherapy + Triptorelin 22.5 mg0
Secondary outcomeCount of participants· 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

GroupValue (Participants)
Brachytherapy3
Brachytherapy + Triptorelin 22.5 mg2
Secondary outcome· Baseline and 5 years.

Change in Quality of Life (QoL) Modifications (Spanish Version of the Expanded Prostate Cancer Index Composite (EPIC) Questionnaire) From Baseline at 5 Years

GroupValue
Brachytherapynot posted
Brachytherapy + Triptorelin 22.5 mgnot posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
BrachytherapySubjects were randomised to receive brachytherapy alone, as either a low dose rate (\[125\]I) or high dose rate (\[192\]I).–3 / 1611 / 16
Brachytherapy + Triptorelin 22.5 mgSubjects received brachytherapy as either a low dose rate (\[125\]I) or high dose rate (\[192\]I). Subjects also received a single intramuscular injection of 22.5 mg triptorelin at Visit 2 (Day 1).–2 / 1510 / 15

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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