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)

NCT ID: NCT06654336

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2031-06-30

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.

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.

Conditions

Prostate Adenocarcinoma; Castration Sensitive Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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®.

Group Type: EXPERIMENTAL

Recurrence-directed therapy (RDT)

Intervention Type: RADIATION

RDT options include radiotherapy or surgical resection.

ELIGARD 22.5mg

Intervention Type: DRUG

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

Recurrence-directed therapy (RDT) alone

Local, regional, and distant oligometastatic RDT.

Group Type: ACTIVE_COMPARATOR

Recurrence-directed therapy (RDT)

Intervention Type: RADIATION

RDT options include radiotherapy or surgical resection.

Interventions

Recurrence-directed therapy (RDT)

RDT options include radiotherapy or surgical resection.

Intervention Type: RADIATION

ELIGARD 22.5mg

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ontario Clinical Oncology Group (OCOG)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Theos Tsakiridis, Dr.

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Jim Wright, Dr.

Role: STUDY_DIRECTOR

Ontario Clinical Oncology Group (OCOG)

Locations

Juravinski Cancer Centre

Hamilton, Ontario, Canada

The Ottawa Hospital Regional Cancer Centre

Ottawa, Ontario, Canada

Countries

Canada

Central Contacts

Lisa Rudd-Scott

Role: CONTACT

ruddl@mcmaster.ca

001-905-527-2299

Facility Contacts

Theos Tsakiridis, Dr.

Role: primary

tsakirid@hhsc.ca

001-905-525-9140

Scott Morgan, MD

Role: primary

Other Identifiers

OCOG-2024-RATΙONAL

Identifier Type: -

Identifier Source: org_study_id