Stereotactic body radiotherapy with or without Darolutamide for OligoRecurrent prostate cancer: a randomized phase II trial (DART)

Prior treatment

• Treatment during the past month with products known to influence PSA levels (e.g. fluconazole, finasteride, corticosteroids,…)
• Currently receiving ADT or PSA rise while on active treatment with ADT (LHRH-agonist, LHRH-antagonist, anti-androgen or estrogen) within the past 6 weeks
• Metastases in previously irradiated areas precluding safe delivery of SBRT
• Previous treatment with cytotoxic agent for PCa

Other illness

• Other active malignancy, except non-melanoma skin cancer or other malignancies with a documented disease-free survival for a minimum of 3 years.

Lab values

• Serum testosterone level <50ng/dl or 1.7 nmol/L at time of randomization

Other

• Local relapse in the prostate gland or prostate bed not suitable for a local salvage treatment
• Small cell carcinoma of the prostate
• PSA doubling time >12 months
• Spinal cord compression or impending spinal cord compression
• Contraindications to darolutamide

• Histologically proven initial diagnosis of adenocarcinoma of the prostate
• Before patient registration/randomization, written informed consent must be given in accordance with to ICH/GCP, and national/local regulations.
• Biochemical relapse of PCa following radical local prostate treatment (radical prostatectomy (RP), primary radiotherapy or the combination of RP and prostate bed adjuvant/ salvage radiotherapy) according to the EAU guidelines 2018.
• Following RP, patients with a biochemical relapse are eligible in case a metastatic relapse is detected even in the absence of prior postoperative prostate bed radiotherapy (adjuvant or salvage). In the absence of prior prostate bed radiotherapy, prostate bed radiotherapy is mandatory for all pT3a or higher or patients with a positive margin at time of RP.
• For patients without prior RP that have a suspected local recurrence following primary radiotherapy, a biopsy should confirm local recurrence. Patients with a confirmed local recurrence and metastases are eligible in case they also undergo a local salvage therapy.
• Metastatic relapse on PSMA PET-CT with a maximum of 5 metastases (any M1a, M1b or M1c). Concomitant diagnosis of N1 disease is allowed as long as all lesions are treated with SBRT and the total number of lesions does not exceed 5. PSMA positive lesions will be scored using the MI-RADS scoring system with lesions scored 4 or 5 considered positive.
• Asymptomatic for metastatic PCa
• Age >=18 years
• WHO class 0-1
• 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