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)
Recruiting · NCT06654336 · Interventional (participants receive a specific treatment) · Lead sponsor: Ontario Clinical Oncology Group (OCOG)
View the official record on ClinicalTrials.gov →Interventions studied
ELIGARD 22.5mgRecurrence-directed therapy (RDT)
What this trial is about
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 take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
- 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 criteria
- Age \< 18.
- ECOG Performance Status ≥3.
- PSA ≥ 20 ng/ml.
- 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.
- 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.
Where it is running
3 locations listed.
- Juravinski Cancer Centre - Hamilton, Ontario, Canada
- The Ottawa Hospital Regional Cancer Centre - Ottawa, Ontario, Canada
- Jewish General Hospital - Montreal, Quebec, Canada