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)
About this study
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.
- Condition
- Prostate Adenocarcinoma, Castration Sensitive Prostate Cancer
- Tested
- Recurrence-directed therapy (RDT), ELIGARD 22.5mg
- Sponsor
- Ontario Clinical Oncology Group (OCOG)
Who can join
- Age
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
Inclusion 10
- Minimum age: 18 years
- Eligible sex: Male
- Study condition: Prostate Adenocarcinoma, Castration Sensitive Prostate Cancer
- 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 10
- 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
3 sites, 3 recruiting
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
The Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, Canada
Contact
-
Lisa Rudd-Scott, RN BScN
905-527-2299 ruddl@mcmaster.ca
-
Daryl Solomon
905-527-2299 solomd5@mcmaster.ca
Potential match only. Final eligibility is determined by the study team.