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) (RATIONAL)

March 11, 2026 updated by: Ontario Clinical Oncology Group (OCOG)

Phase II Randomized Trial of Recurrence-directed Therapy (RDT) With or Without Androgen-Deprivation Therapy (ADT) In Radio-recurrent Oligo-metastatic Hormone/Castrate Sensitive Prostate Cancer (romCSPC).

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A multi-centre, open-label, phase II randomized clinical trial evaluating the addition of Androgen Deprivation Therapy (ADT) utilizing the study drug ELIGARD® compared to Recurrence Directed Therapy (RDT) alone in patients with previously localized prostate adenocarcinoma treated with definitive radiotherapy or with salvage radiotherapy after radical prostatectomy who experience biochemical recurrence and present with oligo-metastases (i.e., < 5 sites of metastases) on conventional imaging. Eligible and consenting patents will be randomized in a 1:1 fashion to either RDT alone (standard arm) or RDT +ADT (ELIGARD®) x12 months (experimental arm). During treatment study participants will be assessed for disease progression, development of castrate resistant prostate cancer (CRPC), acute and late genitourinary (GU) and gastrointestinal (GI) radiotherapy toxicity, the occurrence of adverse events, initiation of tertiary therapy, overall survival and quality of life through the completion of participant questionnaires. Participants will be assessed at standard of care clinic visits every 3 months. The follow-up period is 36 months from the date of randomization. The planned sample size is 162 study participants.

Study Type

Interventional

Enrollment (Estimated)

162

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Lisa Rudd-Scott, RN BScN
  • Phone Number: 43793 905-527-2299
  • Email: ruddl@mcmaster.ca

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada
        • Recruiting
        • Juravinski Cancer Centre
        • Contact:
        • Principal Investigator:
          • Theos Tsakiridis, Dr.
      • Ottawa, Ontario, Canada, K1H8L6
        • Not yet recruiting
        • The Ottawa Hospital Regional Cancer Centre
        • Contact:
          • Scott Morgan, MD
    • Quebec
      • Montreal, Quebec, Canada, H1T2M4
        • Recruiting
        • Jewish General Hospital
        • Principal Investigator:
          • Tamim Niazi, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Previous biopsy-proven localized prostate adenocarcinoma (without predominant features of sarcomatoid, small cell or neuroendocrine carcinoma) treated with definitive or salvage radiotherapy ≥ 2 years or more before enrollment.

  2. Recurrent Oligo-metastatic CSPC, M0 on conventional imaging (bone scan and CT scan of chest/abdomen/pelvis) with ≤ 5 metastases cumulative on all imaging, including MRI and PSMA-PET.

    Note: Patients with conventional imaging M1 oligometastatic CSPC, who have no more than 5 metastatic sites in all imaging modalities including MRI and PSMA-PET, will be accepted for study enrollment.

  3. All sites of recurrent disease must be amenable to treatment with radiotherapy or surgery in the judgment of the investigator.

  4. Biochemical recurrent prostate cancer with ONE of the following PSA recurrence definitions:

    1. After definitive radiotherapy (prostate in situ), with PSA ≥ nadir + 2ng/ml;
    2. After prostatectomy and adjuvant/salvage radiotherapy, with PSA ≥ nadir + 0.2ng/ml.

Exclusion Criteria:

  1. Age < 18.
  2. ECOG Performance Status ≥3.
  3. PSA ≥ 20 ng/ml.
  4. Treatment with ADT within 2 years from study enrollment or treatment with any androgen receptor axis within 6 months from study enrollment.
  5. Prior treatment with chemotherapy for prostate cancer or bilateral orchiectomy. Note: prior chemotherapy for a different type of cancer is allowed if the patient has been continuously disease-free for > 3 years.
  6. Intracranial or intrathecal metastasis.
  7. Spinal cord compression, or spinal intramedullary metastasis.
  8. Prior malignancy (except non metastatic, non- melanomatous skin cancer) unless disease free for > 3 years.
  9. Bilateral hip prosthesis, treated earlier with definitive prostate radiotherapy, who have evidence of local disease recurrence within the prostate and no option for salvage treatment with brachytherapy or surgery.
  10. Previous documented hypersensitivity to ELIGARD® or other GnRH agonist analogs of components of such preparations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Recurrence-directed therapy (RDT) + ADT x 12 months
Local, regional or distant oligometastatic RDT in addition to treatment with ADT for 12 months in the form of ELIGARD®.
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.
Active Comparator: Recurrence-directed therapy (RDT) alone
Local, regional, and distant oligometastatic RDT.
Radiation: Recurrence-directed therapy (RDT)
RDT options include radiotherapy or surgical resection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite progression free survival
Time Frame: Time from randomization to the occurrence of composite PFS event occurring up to the 36 month follow-up.
Biochemical, radiological or clinical progression [composite PFS (cPFS) event]
Time from randomization to the occurrence of composite PFS event occurring up to the 36 month follow-up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease progression
Time Frame: Time from date of randomization, until the date of progression or death occurring up to the 36 month follow-up.
Disease progression: time to biochemical progression (bPFS) (proportion of bPFS events); Disease progression: proportion of conventional-imaging based progression (rPFS) (proportion of rPFS events); Disease progression: proportion with eugonadal progression (egPFS)
Time from date of randomization, until the date of progression or death occurring up to the 36 month follow-up.
Time to initiation of tertiary therapy;
Time Frame: Time of initial therapy to 36 month follow-up.
Any non-protocol treatment given for prostate cancer after protocol-specified intervention.
Time of initial therapy to 36 month follow-up.
Proportion of patients that develop castrate-resistant prostate cancer (CRPC)
Time Frame: During the 36 month follow-up.
Proportion of patients that develop castrate-resistant prostate cancer (CRPC)
During the 36 month follow-up.
Overall survival.
Time Frame: During the 36 month follow-up.
Overall survival.
During the 36 month follow-up.
Rate of early and late Grade 3 or higher GU and GI toxicity.
Time Frame: At 3, 6, 15 and 36 months.
The rate of early and late Grade 3 or higher GU and GI toxicity will be assessed at baseline, 3, 6, 15 and 36 months. The CTCAEv.5.0 (> Grade 3, GI and GU) toxicity rates will be reported.
At 3, 6, 15 and 36 months.
Quality of life assessed by EORTC QLQ C30
Time Frame: Completed by the study participant at scheduled follow-up visits (Months 3, 6, 15 and 36).
Study participant reported quality of life utilizing the following measurement EORTC QLQ C30
Completed by the study participant at scheduled follow-up visits (Months 3, 6, 15 and 36).
Quality of life assessed by EORTC QLQ PR25 questionnaire
Time Frame: Completed by the study participant at scheduled follow-up visits (Months 3, 6, 15 and 36).
Completed by the study participant at scheduled follow-up visits (Months 3, 6, 15 and 36).
Quality of life assessed by EORTC QLQ PRT20 questionnaire
Time Frame: Completed by the study participant at scheduled follow-up visits (Months 3, 6, 15 and 36).
Completed by the study participant at scheduled follow-up visits (Months 3, 6, 15 and 36).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ontario Clinical Oncology Group (OCOG)

Collaborators

Ontario Clinical Oncology Group (OCOG) - McMaster University
TOLMAR PHARMACEUTIQUES CANADA, INC.

Investigators

  • Principal Investigator: Theos Tsakiridis, Dr., McMaster University
  • Study Director: Jim Wright, Dr., Ontario Clinical Oncology Group (OCOG)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 30, 2026

Primary Completion (Estimated)

April 1, 2031

Study Completion (Estimated)

June 1, 2031

Study Registration Dates

First Submitted

October 16, 2024

First Submitted That Met QC Criteria

October 22, 2024

First Posted (Actual)

October 23, 2024

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCOG-2024-RATΙONAL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

A complete de-identified patient-level data set will be made available to academic affiliated researchers for the purpose of meta-analysis or a newly proposed study.

  • Data will be made available following submission of a maximum 2-page proposal. The study Steering Committee will review and, if acceptable, provide approval of the request.
  • A signed data sharing access/transfer agreement will be required between the requesting party and OCOG.
  • Authorship of publications to include the name of the study Principal Investigator.
  • The data will be provided as SAS datasets (as a CPT or XPT file). Any other format requests or additional statistical support may incur costs to the requestor.
  • Data will become available 12 months after publication by the study Principal Investigator, of the initial study results

IPD Sharing Time Frame

Data will become available 12 months after publication by the study Principal Investigator, of the initial study results.

Note: The timeframe may vary based on the journal and internal contractual obligations. The relevant timeframe should be adjusted accordingly to be study specific.

IPD Sharing Access Criteria

A complete de-identified patient-level data set will be made available to academic affiliated researchers for the purpose of meta-analysis or a newly proposed study.

  • Data will be made available following submission of a maximum 2-page proposal. The study Steering Committee will review and, if acceptable, provide approval of the request.
  • A signed data sharing access/transfer agreement will be required between the requesting party and OCOG.
  • Data requests should be submitted to the OCOG Director.

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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