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Prostate CancerProstate healthMen's healthRadiationDrugPhase 3

What this study is

This study is being done to answer the following question: Is the strategy to give higher doses of radiotherapy treatment over a shorter period of time using special equipment and fewer treatments (also known as Stereotactic Body Radiation Therapy or SBRT) as effective as usual external radiation therapy given with a brachytherapy boost (which involves radiation sources inserted directly into the prostate)?

What's being tested

  • Radiation

    Intervention · RADIATION

    46Gy / 23 fractions of EBRT to pelvis and prostate + LDR or HDR boost to prostate OR 25Gy / 5 fractions of EBRT to pelvis and prostate (ultrahypofractionation EBRT (SBRT)) + LDR or HDR boost to prostate. + Adjuvant ADT: Unfavourable Intermediate Risk: 6 months or High / Very High Risk: 24 months

  • Radiation SBRT only

    Intervention · RADIATION

    25Gy / 5 fractions to pelvis + 40 Gy / 5 fractions to prostate (SBRT) (ultrahypofractionation EBRT (SBRT))

  • ADT

    Intervention · DRUG

    Assigned at enrollment

Study details

Official title
Androgen Suppression Combined With Elective Nodal Irradiation and Dose Escalated Prostate Treatment: A Non-Inferiority, Phase III Randomized Controlled Trial of Stereotactic Body Radiation Therapy Versus Brachytherapy Boost in Patients With Unfavourable Risk Localized Prostate Cancer
Sponsor
Canadian Cancer Trials Group
Conditions
Prostate Cancer
Enrolling
710 people
Starts
2024-04-25
Est. completion
2033-04-30
Design
Open-label, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗