NCT04222634Active, not recruiting
Metastasis-directed Therapy in Castration-refractory Prostate Cancer
Metastasis-directed Therapy in Castration-refractory Prostate Cancer MEDCARE : a Non-randomized Phase 2 Trial
Source: ClinicalTrials.gov · Last updated 7 Dec 2023
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- First submitted
- 18 Dec 2019
- Start date
- 27 Dec 2019
- Primary completion date
- 25 Jul 2023
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Diseases
- Prostate cancer
- NCT number
- NCT04222634
What you commit to
- Study type: Interventional
- Planned participants: 18
- From 27 Dec 2019 to the primary completion date, 25 Jul 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatments (RT, surgery) or comorbidities rendering PDT impossible.
Other illness
- Active malignancy other than prostate cancer that can potentially interfere with the interpretation of the trial.
- Disorder precluding understanding of trial information or informed consent or signing informed consent.
Lab values
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gert De Meerleer Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.