NCT06235697

Androgen Suppression Combined With Nodal Irradiation and Dose Escalated Prostate Treatment

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 710 (estimated)
• Sponsor: Canadian Cancer Trials Group · Network
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)?

Detailed description

The usual approach for patients with unfavourable prostate cancer who are not in a study is treatment with external beam radiation therapy (EBRT) to the pelvis and prostate in combination with hormone therapy (androgen deprivation therapy - ADT). To improve control of prostate cancer at risk of returning, additional treatment with a brachytherapy boost (insertion of radiation sources directly into the prostate) is recommended. For patients who get the usual approach for this cancer, about 89 out of 100 are free of cancer after 5 years.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	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	Radiation SBRT only	25Gy / 5 fractions to pelvis + 40 Gy / 5 fractions to prostate (SBRT) (ultrahypofractionation EBRT (SBRT))
DRUG	ADT	Assigned at enrollment

Timeline

• Start date: 2024-04-25
• Primary completion: 2032-10-31
• Completion: 2033-04-30
• First posted: 2024-02-01
• Last updated: 2026-04-14

Locations

57 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study