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

niversity Hospital Ghent0 sites140 target enrollmentAugust 14, 2020

DrugsNUBEQA

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: niversity Hospital Ghent
Enrollment: 140
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 14, 2020

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Investigators

Sponsor

niversity Hospital Ghent

Eligibility Criteria

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 ? 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.

Exclusion Criteria

•? 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
•? Serum testosterone level \<50ng/dl or 1\.7 nmol/L at time of randomization
•? 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
•? Spinal cord compression or impending spinal cord compression
•? Metastases in previously irradiated areas precluding safe delivery of SBRT
•? Contraindications to darolutamide
•? Previous treatment with cytotoxic agent for PCa
•? Treatment during the past month with products known to influence PSA levels (e.g. fluconazole, finasteride, corticosteroids,…)