Study on the Role of Hormonal Treatment for Two Dosage Levels of Prostate Radiation Therapy Versus Prostate Radiation Therapy Alone

Study acronym: PCS III
StatusActive, Not Recruiting
PhasePhase 3
Started

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Record History

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  1. Notable Primary completion date: Dec 31, 2023 to Dec 31, 2026
    • Study completion date: Dec 31, 2023 to Dec 31, 2027
    v11
  2. Notable Primary completion date: May 14, 2018 to Dec 31, 2023
    • Study completion date: Dec 31, 2025 to Dec 31, 2023
    v10
  3. Minor Study completion date: Dec 31, 2020 to Dec 31, 2025
    • Secondary endpoints revised (2)
    v9
  4. Minor Primary completion date changed from estimate of Dec 2017 to May 14, 2018
    • Study completion date: Dec 2018 to Dec 31, 2020
    v8
  5. Notable Primary endpoints: 2 to 1
    • Primary completion date: Jan 2018 to Dec 2017
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. 2 versions Re-verified since Sep 22, 2014, no change to tracked fieldsv5-v6
  2. Notable Lead sponsor: Université de Sherbrooke to Abdenour Nabidv4 Show 9 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Jan 2018
    • Study completion date: Dec 2018
    • Interventions: Drug + radiotherapy (Procedure), Radiotherapy alone (Procedure) to Androgen blockade (Drug), Radiotherapy 70 Gy (Radiation), Radiotherapy 76 Gy (Radiation)
    • Secondary endpoints: details revised at 2 of 2 entries
    • Site details revised
    • Study arms: 0 to 3
    • Eligibility criteria expanded, about 3 words
    • Collaborators expanded, about 1 word
  3. Re-verified, no change to tracked fieldsv3
  4. Minor Interventions: Drug + radiotherapy vs radiotherapy alone (Procedure) to Drug + radiotherapy (Procedure), Radiotherapy alone (Procedure)v2 Show 5 more changesShow less
    • Secondary endpoints revised (2)
    • Primary endpoints revised (2)
    • Study site revised
    • Study title revised
    • Eligibility criteria expanded, about 3 words
  1. Study First Submitted
  • 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 hypothesis of the proposed study would be that, due to the six months of total androgen blockade, which would include neoadjuvant hormonal therapy for four months and concomitant hormonal therapy for two months with irradiation, the investigators could reduce local failure rates for these two dosage levels, namely 70 Gy and 76 Gy. Since increasing the dose to the prostate also seems to reduce local relapse rates, the results of the two hormonal therapy groups would be compared with the results of prostate irradiation at doses of 76 Gy. This study would verify the possibility of compensating a six Gy dosage increase of radiation therapy with six months of hormonal therapy between the 70 Gy and 76 Gy groups who received hormonal therapy, and also match these results with a dose escalation to the prostate of 76 Gy. In the future, this could result in more therapeutic choices, such as reducing the doses of radiation therapy and, consequently, its related complications, if hormonal therapy proves to be beneficial; or rather, to continue in the direction of dose escalation for this intermediate-risk patient group, everything being correlated to the side effects of hormonal therapy and irradiation.
Trial Details
NCT Number NCT00223145
Lead Sponsor Abdenour Nabid
Collaborators: AstraZeneca
Conditions
(from sponsor)
Prostate Cancer
Related terms Prostatic Neoplasms
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov