Recruiting
Phase 2

ADT with ELIGARD®

Sponsor:

Ontario Clinical Oncology Group (OCOG)

Code:

NCT06654336

Conditions

Prostate Adenocarcinoma

Castration Sensitive Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Recurrence-directed therapy (RDT)

ELIGARD 22.5mg

Study Details

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

Study ID

NCT06654336

Start date

May 6, 2026

Status verified date

Jun, 2026

Completion date

Jun, 2031

Anticipated

Primary completion date

Apr, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

162 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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®.

active comparator: Recurrence-directed therapy (RDT) alone

Local, regional, and distant oligometastatic RDT.

Interventions

Recurrence-directed therapy (RDT)

RDT options include radiotherapy or surgical resection.

ELIGARD 22.5mg

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

Primary outcome measure

  • Composite progression free survival [ Time Frame: Time from randomization to the occurrence of composite PFS event occurring up to the 36 month follow-up. ]

Central Contacts and Locations

Central contacts

Locations

Juravinski Cancer Centre

Recruiting

Hamilton, Ontario, Canada

Contacts

Principal Investigator:

Theos Tsakiridis, Dr.

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H1T2M4

Contacts

Principal Investigator:

Tamim Niazi, MD

More Information

Sponsor

Ontario Clinical Oncology Group (OCOG)

Last update posted

Aug 31, 2026

Last verified

Jun, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ontario Clinical Oncology Group (OCOG) on 2026-08-31.