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Androgen Suppression Combined With Nodal Irradiation and Dose Escalated Prostate Treatment

NCT06235697 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 710

Last updated 2026-04-14

No results posted yet for this study

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)?

Conditions

Interventions

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

Sponsors & Collaborators

  • NRG Oncology

    collaborator OTHER

  • Canadian Cancer Trials Group

    lead NETWORK

Principal Investigators

  • Andrew Loblaw · Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON, Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-25
Primary Completion
2032-10-31
Completion
2033-04-30
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06235697 on ClinicalTrials.gov