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.

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.

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.

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

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.

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.