Histologically proven initial diagnosis of adenocarcinoma of the prostate
Rising PSA after local therapy as defined by PSA ≥ 0.2 ng/mL after RP +/- adjuvant/salvage prostate bed RT and at least 2 ng/mL above nadir for primary RT, with a PSADT ≤ 9 months
Serum Testosterone ≥ 150 ng/dl (6.9343 nM/L)
On PSMA PET/CT restaging presence of: 1 to 5 distant metastases that are amenable to MDT ± N1 patients (no limit in the number of nodes)
ECOG performance status 0 - 2
Age \> or =18 years
Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations
You may not be if
More than 5 distant PSMA positive metastases and/or brain or leptomeningeal metastases.
Prostate recurrence (positive PSMA disease) after primary prostate irradiation
Prostate bed recurrence (positive PSMA disease) after salvage/adjuvant irradiation
Pelvic nodal recurrence (positive PSMA disease) after primary WPRT irradiation
Contraindications to pelvic RT and/or MDT
Prior evidence of distant metastatic disease
Contraindications to ADT
Contraindication for treatment with enzalutamide
Prior hormonal therapy (Neoadjuvant/adjuvant therapy to treat PCa ≤ 36 months in duration and ≥ 9 months before randomization is allowed)
Previous treatment with cytotoxic agent for PCa
Any active malignancies (i.e., progressing or requiring any treatment in the previous 36 months) other than prostate cancer (except non-muscle invasive bladder cancer; non-melanomatous skin cancer or a malignancy that is considered cured with minimal risk of recurrence
Clareo Health | Best Salvage Treatment for High-risk Relapsing Prostate Cancer (PEACE-9 - ESCALATE-RT)