Adds ELIGARD hormone therapy to radiation for recurrent prostate cancer
Tests adding ELIGARD hormone therapy to radiation in men with recurrent prostate cancer.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Hamilton, Montreal, Ottawa, and Toronto, CanadaSee the 5 sites
- Phase
- Phase 2
Where in Canada
- Juravinski Cancer CentreHamilton, CanadaTaking people
- Jewish General HospitalMontreal, CanadaTaking people
- McGill University Health Centre (MUHC) - Glen SiteMontreal, CanadaTaking people
- The Ottawa Hospital Regional Cancer CentreOttawa, CanadaNot yet recruiting
- University Health Network - Princess Margaret Cancer CentreToronto, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ontario Clinical Oncology Group (OCOG)
- Trial code
- NCT06654336
- Record updated
- 13 October 2026
- Original description
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.Read full original descriptionShow less
Phase II Randomized Trial of Recurrence-directed Therapy (RDT) With or Without Androgen-Deprivation Therapy (ADT) In Radio-recurrent Oligo-metastatic Hormone/Castrate Sensitive Prostate Cancer (romCSPC).
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.
Inclusion: 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.
Exclusion: 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; 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; Age < 18; Prior malignancy (except non metastatic, non- melanomatous skin cancer) unless disease free for > 3 years; ECOG Performance Status ≥3; PSA ≥ 20 ng/ml; Intracranial or intrathecal metastasis; Spinal cord compression, or spinal intramedullary metastasis.