Study of Recurrence-directed Therapy (RDT) With or Without Androgen-Deprivation Therapy (ADT) In … (NCT06654336) | Clinical Trial Compass
RecruitingPhase 2
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)
Canada162 participantsStarted 2026-03-30
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. 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.
✓. 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 criteria
✕. Age \< 18.
✕. ECOG Performance Status ≥3.
✕
What they're measuring
1
Composite progression free survival
Timeframe: Time from randomization to the occurrence of composite PFS event occurring up to the 36 month follow-up.
✕. 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.
✕. Intracranial or intrathecal metastasis.
✕. Spinal cord compression, or spinal intramedullary metastasis.
✕. Prior malignancy (except non metastatic, non- melanomatous skin cancer) unless disease free for \> 3 years.