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New treatment option for Castration-resistant Prostate Cancer
Official title Metastasis-directed Therapy in Oligoprogressive Castration-refractory Prostate Cancer
ClinicalTrials.gov ID: NCT06585007
What this study is testing
- What it's testing
- Evaluation of the impact of metastasis-directed therapy in patients with castration-refractory prostate cancer and a maximum of 5 progressive lesions.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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...
- Patients with oligoprogressive disease with pADT only as ongoing treatment (Type 1).
You likely can't join if
- 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...
- 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.
See the full eligibility 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...
- Patients with oligoprogressive disease with pADT only as ongoing treatment (Type 1).
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Leuven, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.