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 | Recruiting Phase 2 DMC

• 1 other identifier: OCOG-2024-RATΙONAL
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Prostate adenocarcinoma; Castration Sensitive Prostate Cancer; Recurrent Oligo-metastatic Castration Sensitive Prostate CancerSPC; Andrigen Deprivation Therapy; Eligard; Recurrence Directed Therapy; Radiotherapy; Bio-chemical recurrence; Androgen Deprivation Therapy

Outcome Measures

Primary Outcomes (1)

• Composite progression free survival

  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 Outcomes (8)

• Disease progression

  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 of initial therapy to 36 month follow-up.

• Proportion of patients that develop castrate-resistant prostate cancer (CRPC)

  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.

  At 3, 6, 15 and 36 months.

Study Arms (2)

Recurrence-directed therapy (RDT) + ADT x 12 months

EXPERIMENTAL

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); Drug: ELIGARD 22.5mg

Recurrence-directed therapy (RDT) alone

ACTIVE COMPARATOR

Local, regional, and distant oligometastatic RDT.

Radiation: Recurrence-directed therapy (RDT)

Interventions

Recurrence-directed therapy (RDT) RADIATION

RDT options include radiotherapy or surgical resection.

Recurrence-directed therapy (RDT) + ADT x 12 months; Recurrence-directed therapy (RDT) alone

ELIGARD 22.5mg DRUG

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

Recurrence-directed therapy (RDT) + ADT x 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• All sites of recurrent disease must be amenable to treatment with radiotherapy or surgery in the judgment of the investigator.
• Biochemical recurrent prostate cancer with ONE of the following PSA recurrence definitions:
• After definitive radiotherapy (prostate in situ), with PSA ≥ nadir + 2ng/ml;
• After prostatectomy and adjuvant/salvage radiotherapy, with PSA ≥ nadir + 0.2ng/ml.

You may not qualify if:

• Age \< 18.
• ECOG Performance Status ≥3.
• PSA ≥ 20 ng/ml.
• Treatment with ADT within 2 years from study enrollment or treatment with any androgen receptor axis within 6 months from study enrollment.
• 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.
• Intracranial or intrathecal metastasis.
• Spinal cord compression, or spinal intramedullary metastasis.
• Prior malignancy (except non metastatic, non- melanomatous skin cancer) unless disease free for \> 3 years.
• 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.
• Previous documented hypersensitivity to ELIGARD® or other GnRH agonist analogs of components of such preparations.

Sponsors & Collaborators

• Ontario Clinical Oncology Group (OCOG): lead

Study Sites (3)

Juravinski Cancer Centre

Hamilton, Ontario, Canada

RECRUITING

The Ottawa Hospital Regional Cancer Centre

Ottawa, Ontario, K1H8L6, Canada

NOT YET RECRUITING

Jewish General Hospital

Montreal, Quebec, H1T2M4, Canada

RECRUITING

MeSH Terms

Interventions

luprolide acetate gel depot

Study Officials

• Theos Tsakiridis, Dr.

  McMaster University

  PRINCIPAL INVESTIGATOR

• Jim Wright, Dr.

  Ontario Clinical Oncology Group (OCOG)

  STUDY DIRECTOR

Central Study Contacts

Lisa Rudd-Scott, RN BScN

CONTACT

905-527-2299; ruddl@mcmaster.ca

Daryl Solomon

CONTACT

905-527-2299; solomd5@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 23, 2024
• Study Start: March 30, 2026
• Primary Completion (Estimated): April 1, 2031
• Study Completion (Estimated): June 1, 2031
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• 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.
• 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.

Locations

CA (3)