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Duration of Androgen Blockade Combined With Pelvic Irradiation in Prostate Cancers

Study acronym: PCS IV
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 31, 2023 to Dec 31, 2026 Completion date: Dec 31, 2023 to Dec 31, 2027v11 Show all 2 changesShow less
    • Completion date: Dec 31, 2023 to Dec 31, 2027
  2. Primary completion date: Oct 4, 2018 to Dec 31, 2023 Enrollment target: estimated 650 to confirmed 630 · Completion date: Dec 31, 2025 to Dec 31, 2023v10 Show all 3 changesShow less
    • Enrollment target: estimated 650 to confirmed 630
    • Completion date: Dec 31, 2025 to Dec 31, 2023
  3. Completion date: Dec 31, 2020 to Dec 31, 2025v9
  4. Primary completion date changed from estimate of Dec 2017 to Oct 4, 2018 Completion date: Dec 2018 to Dec 31, 2020v8 Show all 2 changesShow less
    • Completion date: Dec 2018 to Dec 31, 2020
  5. Primary completion date: Jan 2016 to Dec 2017 Completion date: Dec 2016 to Dec 2018v7 Show all 2 changesShow less
    • Completion date: Dec 2016 to Dec 2018
Show 5 earlier versionsHide 5 earlier versions
  1. 2 versions Re-verified since Sep 22, 2014, no change to tracked fieldsv5-v6
  2. Trial status: Recruiting to Active, Not Recruiting Enrollment target: 600 to 650 · Primary completion date: Jan 2016 · Completion date: Dec 2016 · 6 morev4 Show all 10 changesShow less
    • Enrollment target: 600 to 650
    • Primary completion date: Jan 2016
    • Completion date: Dec 2016
    • Interventions: Androgen blockade + radiation therapy (Procedure) to Androgen blockade + radiation therapy (Drug)
    • Secondary endpoints: details revised at 4 of 4 entries
    • Site details revised
    • Study arms: 0 to 2
    • Eligibility criteria expanded, about 1 word
    • Collaborators expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Eligibility criteria expanded, about 8 words Study site revised · Study title revisedv3 Show all 3 changesShow less
    • Study site revised
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  4. Site contact updatedv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The objective of this study is to use as a reference the 36-month duration of hormonal therapy according to the European Organization for Research of the Treatment of Cancer (EORTC protocol 22863) : namely one-month of total androgen blockade followed by a luteinizing hormone releasing hormone (LHRH) agonist, all for three years, combined with pelvic and prostate irradiation; this arm is currently considered to be a standard for high-risk prostate cancers. The proposed study intends to challenge the duration of hormonal therapy and verify whether the five-year outcomes in favour of combined treatment in regard to survival (79% versus 62%) and local control (85% versus 48%) can be transposed for hormonal therapy that is half as long, namely 18 months, with the possibility of hormone salvage therapy in the event of biochemical and/or clinical failure (local, regional, or distant); this applies to both arms. The proposed study will compare survival in the two groups and evaluate in each one the total duration of initial hormonal therapy, followed by initial hormonal therapy combined with salvage hormonal therapy, the duration of salvage hormonal therapy until hormonal therapy resistance, and the side effects of this hormonal therapy, with everything being related to an assessment of the quality of life of these patients.
Trial Details
NCT Number NCT00223171
Lead Sponsor Université de Sherbrooke
Collaborators: AstraZeneca
Conditions Prostate Cancer
Enrollment 630 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov