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Study of Recurrence-directed Therapy (RDT) With or Without Androgen-Deprivation Therapy (ADT) In Patients With Radio-recurrent Oligo-metastatic Hormone/Castrate Sensitive Prostate Cancer (romCSPC)

NCT06654336 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2026-03-13

No results posted yet for this study

Summary

The goal of this study is to determine whether the addition of Androgen Deprivation Therapy (ADT) utilizing the study drug ELIGARD® to Recurrence- Directed Therapy (RDT) improves progression-free survival (PFS) compared to RDT alone in patients with early radio-recurrent oligo-metastatic castrate / hormone sensitive prostate cancer (romCSPC). Participants will be assessed at standard of care clinic visits every 3 months. The follow-up period is 36 months.

Conditions

  • Prostate Adenocarcinoma
  • Castration Sensitive Prostate Cancer

Interventions

RADIATION

Recurrence-directed therapy (RDT)

RDT options include radiotherapy or surgical resection.

DRUG

ELIGARD 22.5mg

ADT in the form of ELIGARD 22.5 mg every 3 months for a total of 12 months.

Sponsors & Collaborators

  • Ontario Clinical Oncology Group (OCOG)

    lead OTHER

Principal Investigators

  • Theos Tsakiridis, Dr. · McMaster University

  • Jim Wright, Dr. · Ontario Clinical Oncology Group (OCOG)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-30
Primary Completion
2031-04-30
Completion
2031-06-30

Countries

  • Canada

Study Locations

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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 NCT06654336 on ClinicalTrials.gov