Trial · Interventional
Active, not recruitingPhase 3Registry dataTrial Comparing Irradiation Plus Long Term Adjuvant Androgen Deprivation With GnRH Antagonist Versus GnRH Agonist Plus Flare Protection in Patients With Very High Risk Localized or Locally Advanced Prostate Cancer
Short name PEGASUS
Overview
- Status
- Active, not recruiting
- Phase
- Phase 3
- Enrollment
- 885 participants (estimated)
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC · Network
- Design
- Randomized · Open label (no masking)
- Countries
8 countries
Belgium, Denmark, France, Germany, Italy, Spain, Switzerland, United Kingdom
- Start
- 25 Sept 2017
- Primary completion
- 23 Aug 2023
- Completion
- 30 Jun 2026 (estimated)
- First posted
- 15 Jun 2016 (estimated)
- Last update posted
- 22 May 2026
- Conditions
- Prostate Cancer
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 3
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The primary objective of the trial is to assess if GnRH antagonists in combination with external beam radiation therapy improve progression free survival (progression that can be biological, clinical, or death) compared to GnRH agonists in combination with external beam radiation therapy. Secondary objectives include: * documentation of effect of GnRH antagonists on clinically significant cardiovascular events in the subgroup of patients at high risk of such events at baseline; * documentation of side effects and quality of life, I-PSS and urinary tract infections; * assessment of relative treatment effect on secondary efficacy endpoints (clinical progression, time to next line of systemic therapy, time on therapy, overall and cancer specific survival) and on PSA at 6 months after end of RT.
Interventions
- DegarelixDrug
- approved GnRH agonistDrug
- RadiotherapyRadiation
Arms2
Active comparator
GnRH agonist + radiation therapy (RT)
As the study investigates the effect of a drug given concomitantly to radiotherapy, all patients will be treated with the same treatment technique and target dose. The preferred treatment technique is intensity modulated radiotherapy (IMRT) + A GnRH-agonist will be given for the duration selected for each patient. A non-steroidal anti-androgen (e. g. flutamide, bicalutamide) will be given orally one week before the first injection of the GnRH agonist and will be continued for no longer than 8 weeks to protect against flare. Dose may vary due to availability of different brand names and pharmaceutical forms The start of antiandrogen must be registered as day 1 of treatment in the GnRH agonist arm.
Experimental
GnRH antagonist + radiation therapy (RT)
As the study investigates the effect of two drugs given concomitantly to radiotherapy, all patients will be treated with the same treatment technique and target dose. The preferred treatment technique is intensity modulated radiotherapy (IMRT) +a GnRH antagonist will be given for a predefined duration of 18, 24, or 36 months as per institution policy. Each institution has to adhere to the chosen duration of treatment for all patients throughout the study
Primary outcomes1
Outcomes the sponsor listed as primary.
Progression free survival
Time frame · through study completion, an average of 1 year
Registry description
The primary endpoint is progression-free survival defined as the time in days from randomization to death, clinical or biochemical progression, whichever comes first. Where * PSA progression based on Phoenix definition, i.e. a rise by 2 ng/mL or more above the nadir PSA (Ref. 17) confirmed by a second value measured minimum 3 months later * Clinical progression is defined as onset of obstructive symptoms requiring local treatment and demonstrated to be caused by cancer progression or evidence of metastases detected by clinical symptoms and confirmed by imaging * Start of another line of systemic therapy in absence of progression * Death due to any cause
Secondary outcomes(6)
Clinical progression-free survival
Time frame · through study completion, an average of 1 year
Time to next systemic anticancer therapy (including secondary hormonal manipulation)
Time frame · through study completion, an average of 1 year
♦ Proportion of patients switching from GnRH antagonists to GnRH agonists
Time frame · through study completion, an average of 1 year
♦ Overall survival
Time frame · through study completion, an average of 1 year
Incidence of clinical cardiovascular events
Time frame · through study completion, an average of 1 year
Registry description
♦ the incidence of clinical cardiovascular events - CCE (i.e. arterial embolic or thrombotic events, hemorrhagic or ischemic cerebrovascular conditions, myocardial infarction, and other ischemic heart disease) in patients who had cardiovascular events before entering the trial and in those without such events.
♦ Incidence of urinary tract infection
Time frame · through study completion, an average of 1 year
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
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.
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedZengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2. PMID 34350976
Eligibility
Who could join, as posted.
- Sex
- Male
- Age
- from 18 Years up to 80 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
PepBank is a research reference. Talk to a doctor before you use any peptide.