Actively Recruiting
Metastasis-directed Therapy in Oligoprogressive Castration-refractory Prostate Cancer: a Randomized Phase 3 Trial
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-09-05
246
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of progression-directed therapy in patients with castration-refractory prostate cancer who have up to 5 progressing lesions. This phase 3, randomized, open-label trial aims to compare overall survival in patients with oligoprogressive metastatic castration-resistant prostate cancer (mCRPC). Patients are grouped based on number and location of metastases and systemic therapy type before randomization, which follows approval by a multidisciplinary tumor board. Participants are randomly assigned to one of two groups. One group receives standard care, which may include surveillance with ongoing systemic treatment or starting new systemic treatments such as abiraterone acetate, enzalutamide, apalutamide, chemotherapy, or radionuclide therapy. The other group receives progression-directed therapy (either metastasectomy or stereotactic body radiation therapy) while continuing their current systemic treatment, except for those currently on docetaxel. If new lesions appear after progression-directed therapy, repeated therapy is required. During the study, participants will have regular assessments including imaging every 6 months or as needed, and quality of life questionnaires at baseline and several follow-up points up to 24 months. Researchers will monitor overall survival up to 5 years, cancer-specific survival, radiographic progression-free survival, and treatment-related toxicity. This comprehensive monitoring will help determine the effects of progression-directed therapy in this patient population.
CONDITIONS
Brief Title
Metastasis-directed Therapy in Oligoprogressive Castration-refractory Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent prior to screening procedures
- Diagnosed with acinar adenocarcinoma including neuro-endocrine dedifferentiation
- Oligoprogressive disease on imaging with a maximum of 3 extracranial progressive lesions within 6 weeks prior to randomization
- Castration-refractory disease with testosterone level below 50 ng/dL
- Prior treatment of the primary tumor by radiotherapy or surgery (mandatory if not previously treated)
- WHO performance status of 0 to 2
- Age 18 years or older
- No psychological, sociological, or geographical conditions that may impact study compliance
- Approval by multidisciplinary tumor board for trial inclusion
You will not qualify if you...
- Diagnosis of ductal adenocarcinoma or small-cell prostate cancer
- Serum testosterone level above 50 ng/mL
- Presence of more than 3 progressive lesions or poly-progressive disease on imaging
- Active malignancy other than prostate cancer that could interfere with the trial
- Prior treatments or comorbidities preventing stereotactic body radiation therapy
- Highly symptomatic or unstable spinal bone lesions
- Previous treatment with radionuclides, cabazitaxel, or PARP inhibitors
- Progressive disease during docetaxel treatment
- Inability to understand the treatment protocol or provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or discontinuation
Participants receive either standard of care therapy or progression-directed therapy such as metastasectomy or stereotactic body radiation therapy while continuing systemic treatment. Those in the progression-directed therapy arm may undergo repeated therapy if new lesions appear.
Visits scheduled according to treatment and follow-up plans
Duration - Up to 5 years
Participants are monitored with quality of life assessments and imaging to evaluate progression and toxicity for up to 5 years after randomization.
Visits at month 1, 3, 6, 12, 24 and every 6 months during follow-up or as needed
Trial Site Locations
Total: 1 location
1
University Hospitals Leuven
Leuven, Belgium
Actively Recruiting
Research Team
K
Kato Rans, MD
G
Gert De Meerleer, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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