Clinical trial · Interventional
Metastasis-directed Therapy in Castration-refractory Prostate Cancer
Metastasis-directed Therapy in Castration-refractory Prostate Cancer MEDCARE : a Non-randomized Phase 2 Trial
NCT04222634CI-TRIAL-00072043MEDCAREactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim is to define the postponement of next line systemic treatment (NEST), by the use of metastasis-directed therapy in patients with oligoprogressive castration-refractory prostate cancer. This will be defined by the NEST-free survival. Furthermore the investigators will use 18F PSMA PET-CT as investigational imaging, to assess the predictive value and impact on treatment policy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy (SBRT) and/or surgery (metastasectomy) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- MDT for oligoprogressive lesions in CRPC
- description
- metastasis-directed therapy: * radiotherapy (SBRT or conventional radiotherapy in case of local recurrence or untreated primary tumor) * metastasectomy * salvage lymphadenectomy * salvage prostatectomy in case of local recurrence or untreated primary tumor
- interventionNames
- Other: Radiotherapy (SBRT) and/or surgery (metastasectomy)
Primary outcomes (2)
- measure
- Next-line Systemic Treatment - free survival (NEST-FS)
- timeFrame
- up to 5 years after MDT
- description
- Time until the start with a subsequent systemic treatment line calculated from the last day of MDT until the first day of NEST or death (whichever comes first)
- measure
- PSMA PET-CT accuracy and predictive value
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven initial diagnosis of adenocarcinoma of the prostate * mCRPC setting, with testosterone level \< 50 ng/dl or 1.7 nmol/l * Oligoprogressive disease, defined as a maximum of 3 extracranial metastases in any organ system OR local recurrence, diagnosed on conventional imaging with CT and bone scan. This may present as either the progression of pre-existing disease, and/or the appearance of new metastases. (defined according to the PCWG 3 criteria (20), see section 6. Trial Procedures) * Patients currently treated with ADT, whether or not combined with another systemic treatment such as abiraterone acetate, enzalutamide, docetaxel and radium-223. Denosumab is allowed but not considered as second-line systemic treatment. * Priory treated primary tumor by radiotherapy or surgery. If the primary tumour is not treated, local therapy should be added to the treatment. Both radiotherapy as well as surgery are allowed. * WHO performance status 0-1 * Age \>= 18 years old * Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and/or follow-up schedule. Those conditions should be discussed with the patient before registration in the trial. * Patient presented at the multidisciplinary tumour board of the local hospital. * Before patient registration/randomization, written informed consent must be given according to ICH/GCO and national/local regulations. Exclusion Criteria: * Serum testosterone level \> 50 ng/ml or \> 1.7 nmol/l. * Presence of polyprogression, defined as more than 3 progressive/new metastatic lesions and/or local recurrence (which counts for 1 lesion). * Active malignancy other than prostate cancer that can potentially interfere with the interpretation of the trial. * Previous treatments (RT, surgery) or comorbidities rendering PDT impossible. * Disorder precluding understanding of trial information or informed consent or signing informed consent.
References
Publications (1)
- DERIVEDBerghen C, Joniau S, Rans K, Devos G, Poels K, Slabbaert K, Dumez H, Albersen M, Goffin K, Haustermans K, De Meerleer G. Metastasis-directed therapy in castration-refractory prostate cancer (MEDCARE): a non-randomized phase 2 trial. BMC Cancer. 2020 May 24;20(1):457. doi: 10.1186/s12885-020-06853-x. PMID 32448171