NCT06585007 Metastasis-directed Therapy in Oligoprogressive Castration-refractory Prostate Cancer
| NCT ID | NCT06585007 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Castration-resistant Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 246 participants |
| Start Date | 2023-12-19 |
| Primary Completion | 2029-01-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 246 participants in total. It began in 2023-12-19 with a primary completion date of 2029-01-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Evaluation of the impact of metastasis-directed therapy in patients with castration-refractory prostate cancer and a maximum of 5 progressive lesions.
Eligibility Criteria
Inclusion Criteria: Participants eligible for inclusion in this Trial must meet all the following criteria: * Written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures. * Acinar adenocarcinoma (inclusive neuro-endocrine dedifferentiation). * Oligoprogressive disease on conventional imagine within a maximum of 6 weeks prior to randomisation defined as: a maximum of 3 extracranial progressive lesions (pre-existing lesions, the development of new lesions, or both) in any organ. Nodal (N1) disease should be measured in the short axis. Nodes more than 1.5 cm in the short axis are considered pathologic and measurable. Oligoprogression on bone scan is defined as the occurrence of maximal 3 new and/or progressive lesions. In case of not unambiguously, additional imaging such as diagnostic magnetic resonance imaging (MRI) or dedicated CT-scan should be performed. Visceral disease reported separately (lung, liver, adrenal, or CNS) and is considered measurable if an individual lesions is more than 1 cm longest dimension. In case of locally persistent/recurrent disease, a diagnostic MRI of the prostate (bed) and/or biopsy of the site is recommended. There are two different mCRPC patient groups who are eligible for inclusion in the trial: 1. Patients with oligoprogressive disease with pADT only as ongoing treatment (Type 1). 2. Patients with oligoprogressive disease with pADT +/- second line systemic therapy. This is both the combination of pADT + ARTA as ongoing treatment or patients who had received docetaxel in the past (Type 2). * Castration-refractory disease, defined as testosterone level \< 50 ng/dL. * Prior treatment of the primary tumor by radiotherapy or surgery. If the primary tumor has not been treated previously, this treatment is obligatory within the trial. * WHO performance 0-2 * Age \>= 18 years old * Absence of psychological, sociological, or geographical condition potentially hampering compliance with study protocol. * Patients must be presented at the multidisciplinary board meeting and the inclusion in the trial needs approval by this board. Exclusion Criteria: * Ductal adenocarcinoma and small-cell prostate cancer. * Serum testosterone level \> 50 ng/ml. * Presence of poly-progressive disease, defined as more than 3 progressive lesions on conventional imaging or nodal and/or metastatic lesions on conventional imaging * Active malignancy other than prostate cancer that could potentially interfere with the interpretation of this trial. * Previous treatments (RT, surgery) or comorbidities rendering new treatment with SBRT impossible. * Spinal bone lesion that is highly symptomatic, neurologically threatening or at risk of fracture. * Patients already treated with radionuclides, cabazitaxel or PARP-inhibitors in the past. * Patients with progressive disease while receiving docetaxel. * Not able to understand the treatment protocol or sign informed consent.
Contact & Investigator
Gert De Meerleer, MD, PhD
PRINCIPAL INVESTIGATOR
Universitaire Ziekenhuizen KU Leuven
Frequently Asked Questions
Who can join the NCT06585007 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Castration-resistant Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06585007 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 246 participants.
Is NCT06585007 currently recruiting?
Yes, NCT06585007 is actively recruiting participants. Contact the research team at kato.rans@uzleuven.be for enrollment information.
Where is the NCT06585007 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT06585007 clinical trial?
NCT06585007 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is Gert De Meerleer, MD, PhD at Universitaire Ziekenhuizen KU Leuven. The trial plans to enroll 246 participants.
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