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Evaluation of the impact of metastasis-directed therapy in patients with castration-refractory prostate cancer and a maximum of 5 progressive lesions.
EU CTIS ID: 2022-502254-13-00
What this study is testing
The aim is to investigate whether the addition of metastasis-directed therapy will increase overall survival as compared to standard of care treatment in patients with oligoprogressive metastatic castration-refractory prostate cancer. Overall survival will be calculated from the day of randomization until death from any cause.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Voluntary 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).
- Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as true secsual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)), use of condom or vasectomy or commitment to a partner using implants, injectables, combined oral contraceptives or some IUDs (27). This method of contraception needs to be continued for at least 6 months after the last dose of Trial treatment(s).
- Oligoprogressive disease defined as a maximum of 5 extracranial progressive lesions (pre-existing lesions, the development of new lesions, or both) in any organ reported according to the PROMISE V2 Framework for the standardized reporting of PSMA PET for research and clinical routine. In case of locally persistent/recurrent disease, a diagnostic magnetic resonance imaging (MRI) or dedicated CT-scan should be performed. If a metastatis in the extremities is suspected, a bone scan or dedicated CT-scan will be performed. 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: a. Patients with oligoprogressive disease with pADT only as ongoing treatment (Type 1). b. 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 or 1.7 nmol/L and the presence of biochemical or radiologic progression.
- Prior treatment of the primary tumor by radiotherapy or surgery. If the primary tumor had not been treated, local therapy should be added to the treatment together MDT.
You likely can't join if
- Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol
- Ductal adenocarcinoma and small-cell prostate cancer
- Spinal bone lesion that is highly symptomatic, neurologically threatening or at risk of fracture will be excluded.
- Patients with progressive disease while receiving docetaxel at the moment of progression.
- Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial.
- Participation in an interventional Trial with an investigational medicinal product (IMP) or device
See the full eligibility criteria
Who can join
- Voluntary 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).
- Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as true secsual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)), use of condom or vasectomy or commitment to a partner using implants, injectables, combined oral contraceptives or some IUDs (27). This method of contraception needs to be continued for at least 6 months after the last dose of Trial treatment(s).
- Oligoprogressive disease defined as a maximum of 5 extracranial progressive lesions (pre-existing lesions, the development of new lesions, or both) in any organ reported according to the PROMISE V2 Framework for the standardized reporting of PSMA PET for research and clinical routine. In case of locally persistent/recurrent disease, a diagnostic magnetic resonance imaging (MRI) or dedicated CT-scan should be performed. If a metastatis in the extremities is suspected, a bone scan or dedicated CT-scan will be performed. 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: a. Patients with oligoprogressive disease with pADT only as ongoing treatment (Type 1). b. 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 or 1.7 nmol/L and the presence of biochemical or radiologic progression.
- Prior treatment of the primary tumor by radiotherapy or surgery. If the primary tumor had not been treated, local therapy should be added to the treatment together MDT.
- WHO performance 0-2
- Age 18 years or older
- 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
What rules you out
- Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol
- Ductal adenocarcinoma and small-cell prostate cancer
- Spinal bone lesion that is highly symptomatic, neurologically threatening or at risk of fracture will be excluded.
- Patients with progressive disease while receiving docetaxel at the moment of progression.
- Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial.
- Participation in an interventional Trial with an investigational medicinal product (IMP) or device
- Serum testosterone level > 50 ng/ml or 1.7 nmol/l.
- Presence of poly-progressive disease, defined as more than 5 progressive lesions on PSMA PET-CT including local recurrence, nodal disease and/or metastatic lesions.
- 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.
- Not able to understand the treatment protocol or sign informed consent.
- Patients already treated with radionuclides, cabazitaxel or PARP-inhibitors in the past.
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.