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)

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.

Trial Details

NCT ID
NCT06654336
Phase
PHASE2
Sponsor
Ontario Clinical Oncology Group (OCOG)
Status
RECRUITING
Cancer Type
Hormone-Sensitive Prostate Cancer
Interventions
  • Recurrence-directed therapy (RDT)
  • ELIGARD 22.5mg
Locations (sample)
  • Hamilton, Ontario, Canada|43.25011,-79.84963
  • Ottawa, Ontario, Canada|45.41117,-75.69812
  • Montreal, Quebec, Canada|45.50884,-73.58781

Key Eligibility Criteria

  • Previous biopsy-proven localized prostate adenocarcinoma (without predominant features of sarcomatoid, small cell or neuroendocrine carcinoma) trea…
  • Recurrent Oligo-metastatic CSPC, M0 on conventional imaging (bone scan and CT scan of chest/abdomen/pelvis) with ≤ 5 metastases cumulative on all i…
  • Note: Patients with conventional imaging M1 oligometastatic CSPC, who have no more than 5 metastatic sites in all imaging modalities including MRI …
  • All sites of recurrent disease must be amenable to treatment with radiotherapy or surgery in the judgment of the investigator.

For full eligibility, visit ClinicalTrials.gov.

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