Stereotactic Body Radiotherapy With or Without Darolutamide for OligoRecurrent Prostate Cancer
DART
1 other identifier
interventional
124
1 country
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 prostate-cancer
Started Feb 2021
Typical duration for phase_2 prostate-cancer
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2020
CompletedFirst Posted
Study publicly available on registry
November 23, 2020
CompletedStudy Start
First participant enrolled
February 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 12, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 12, 2026
CompletedFebruary 28, 2024
February 1, 2024
5 years
November 17, 2020
February 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Metastasis-free survival
Metastasis-free survival is defined as time between randomization and the appearance of a new metastatic recurrence (any M1) as suggested by PET-CT or death due to any cause.
2 year
Secondary Outcomes (10)
Clinical progression-free survival
2 year
Biochemical relapse-free survival
2 year
Time to next systemic therapy
4 year
Castrate resistant-free survival
4 year
Prostate cancer-specific survival
4 year
- +5 more secondary outcomes
Study Arms (2)
Arm A
EXPERIMENTALSBRT + 6 months of darolutamide (600 mg b.i.d.)
Arm B
OTHERSBRT only
Interventions
Eligibility Criteria
You may qualify if:
- 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 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 in accordance with to ICH/GCP, and national/local regulations.
You may not qualify if:
- 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,…)
- Other active malignancy, except non-melanoma skin cancer or other malignancies with a documented disease-free survival for a minimum of 3 years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
OLVZ Aalst
Aalst, Belgium
GZA
Antwerp, Belgium
AZ St-Jan Brugge
Bruges, Belgium
Institut Jules Bordet
Brussels, Belgium
AZ St-Lucas Gent
Ghent, Belgium
Ghent University Hospital
Ghent, Belgium
Jessa Ziekenhuis
Hasselt, Belgium
AZ Groeninge
Kortrijk, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Piet Ost, MD, PhD
University Hospital, Ghent
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2020
First Posted
November 23, 2020
Study Start
February 12, 2021
Primary Completion
February 12, 2026
Study Completion
February 12, 2026
Last Updated
February 28, 2024
Record last verified: 2024-02