Stereotactic Body Radiotherapy With or Without Darolutamide for OligoRecurrent Prostate Cancer (NCT04641078) | Clinical Trial Compass
UnknownPhase 2
Stereotactic Body Radiotherapy With or Without Darolutamide for OligoRecurrent Prostate Cancer
Belgium124 participantsStarted 2021-02-12
Plain-language summary
The current trial will test the combination of darolutamide with SBRT, in oligometastatic recurrent hormone sensitive prostate cancer. We hypothesize that the addition of short-term darolutamide improves metastasis-free survival when added to SBRT without a detrimental impact on the QoL. Considering the large reluctance of both patients and physicians to be randomized to observation, we propose to use the historical data from previous reported randomized trials (STOMP and ORIOLE) as a comparator to explore as a secondary endpoint.
Who can participate
Age range18 Years
SexMALE
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Inclusion Criteria:
* Histologically proven initial diagnosis of adenocarcinoma of the prostate
* 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 positive19.
* Asymptomatic for metastatic PCa
* Age \>= 18 years
* WHO class 0-1
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with …