Recurrence-directed therapy with or without 12 months of androgen-deprivation (ELIGARD) for radio-recurrent oligo-metastatic, hormone-sensitive prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multi-centre, open-label phase II randomized trial enrolling 162 men with prior radiotherapy-treated prostate adenocarcinoma who develop biochemical recurrence with up to five metastases. Participants are randomized 1:1 to receive recurrence-directed therapy (RDT) alone or RDT plus 12 months of ELIGARD® (leuprolide) as androgen-deprivation therapy. The primary outcome is progression-free survival, with secondary outcomes including development of castration-resistant disease, radiotherapy-related GU/GI toxicity, adverse events, initiation of further therapies, overall survival, and quality of life; follow-up visits occur every three months for 36 months. Imaging and clinical assessments will guide management and outcome measurements.

Why it matters

Who can join: the full rules

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.

Where it's running

• Juravinski Cancer Centre
  Hamilton, Ontario, Canada Recruiting
• University Health Network Princess Margaret Cancer Centre
  Toronto, Ontario, Canada Recruiting
• Jewish General Hospital
  Montreal, Quebec, Canada Recruiting
• McGill University Health Centre (MUHC) - Glen Site
  Montreal, Quebec, Canada Recruiting
• The Ottawa Hospital Regional Cancer Centre
  Ottawa, Ontario, Canada Not yet recruiting

Study contacts

• Principal investigator: Theos Tsakiridis, Dr. — McMaster University
• Study coordinator: Lisa Rudd-Scott, RN BScN
• Email: ruddl@mcmaster.ca
• Phone: 905-527-2299

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.