Eligibility Details:
Inclusion Criteria:
- Histologic diagnosis/confirmation of prostate adenocarcinoma and no evidence of small
cell cancer.
- Stage IV at presentation or relapse after curative intent therapy, classification per
AJCC 8th edition: M1 disease with ≤ 5 metastases
- ≤ 3 metastases in any non-bone organ system
- Zoladex must commence within 12 weeks prior to randomization or within 6 weeks after
randomization.
- Radiology (CT/MRI chest/abdomen/pelvis) within 28 days of randomization
- Bone scan within 28 days of randomization
- All tumours (Primary prostate and metastases) must be amenable to local ablative
therapy (SBRT and/or surgery).
- Age ≥ 18
- ECOG performance 0-1
- Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life
and economics questionnaires in either English or French
- Patient consent must be appropriately obtained in accordance with applicable local and
regulatory requirements. Each patient must sign a consent form prior to enrollment in
the trial to document their willingness to participate
- Patients must be medically suitable for study treatments as assessed by the
appropriate specialties: medical, radiation, and surgical
- Patients with a prior or concurrent malignancy whose natural history or treatment does
not have the potential to interfere with the safety or efficacy assessment of the
investigational regimen
- Patients must be accessible for treatment and follow-up. Investigators must assure
themselves the patients randomized on this trial will be available for complete
documentation of the treatment, adverse events, and follow-up
- In accordance with CCTG policy, ablative therapy to metastases is to begin within 6
weeks after patient randomization
- Men of childbearing potential must have agreed to use a highly effective contraceptive
method to prevent pregnancy while on study
- Patient must consent to provision of, and Investigator must confirm access to and
agree to submit tumour tissue and whole blood for cfDNA.
Exclusion Criteria:
- Prior treatment with ADT in the neoadjuvant or adjuvant setting, unless treatment was
discontinued ≥ 12 prior to randomization AND total duration of treatment was ≤ 36
months (including expiry of last depot injection).
- Previously diagnosed recurrent/metastatic disease which has been already treated with
any systemic therapy or radiotherapy
- Castration resistant prostate cancer, defined as rising PSA or radiographic
progression in the setting of castrate levels of serum testosterone (< 1.7 nmol/L).
- Patients with previously untreated pelvic lymph nodes (N1), as the only site of
disease at enrollment.
- Inability to treat all sites of disease with local ablative therapy
- Patients with parenchymal brain metastases