Combining darolutamide with targeted radiotherapy for recurrent prostate cancer
Stereotactic Body Radiotherapy With or Without Darolutamide for OligoRecurrent Prostate Cancer: a Randomized Phase II Trial (DART)
This study is testing if combining a medication called darolutamide with targeted radiation therapy can help men with recurring prostate cancer live longer without worsening their quality of life.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University Hospital, Ghent Academic / other |
| Locations | 8 sites (Aalst and 7 other locations) |
| Trial ID | NCT04641078 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of combining darolutamide, an androgen receptor inhibitor, with stereotactic body radiotherapy (SBRT) in patients with oligometastatic recurrent hormone-sensitive prostate cancer. The study aims to determine if this combination improves metastasis-free survival without negatively impacting the quality of life. Historical data from previous trials will be used as a comparator to assess outcomes. The trial addresses a gap in treatment guidelines for patients with limited metastases following local therapy.
Who should consider this trial
Good fit: Ideal candidates include men with a confirmed diagnosis of oligometastatic recurrent hormone-sensitive prostate cancer who have experienced biochemical relapse after local treatment.
Not a fit: Patients with advanced metastatic prostate cancer or those who have not undergone prior local therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates for patients with recurrent prostate cancer while maintaining their quality of life.
How similar studies have performed: Previous studies have shown promise in using metastasis-directed therapies for oligometastatic prostate cancer, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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 \>= 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. 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,...) * Other active malignancy, except non-melanoma skin cancer or other malignancies with a documented disease-free survival for a minimum of 3 years.
Where this trial is running
Aalst and 7 other locations
- OLVZ Aalst — Aalst, Belgium (Recruiting)
- Gza — Antwerp, Belgium (Recruiting)
- AZ St-Jan Brugge — Brugge, Belgium (Recruiting)
- Institut Jules Bordet — Brussel, Belgium (Recruiting)
- AZ St-Lucas Gent — Gent, Belgium (Recruiting)
- Ghent University Hospital — Ghent, Belgium (Recruiting)
- Jessa Ziekenhuis — Hasselt, Belgium (Recruiting)
- AZ Groeninge — Kortrijk, Belgium (Recruiting)
Study contacts
- Principal investigator: Piet Ost, MD, PhD — University Hospital, Ghent
- Study coordinator: Piet Ost, MD, PhD
- Email: piet.ost@ugent.be
- Phone: 003293323015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.