Metastasis-directed Therapy in Castration-refractory Prostate Cancer MEDCARE : a Non-randomized Phase 2 Trial


Condition: Castration-resistant Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04222634

Sponsor: Universitaire Ziekenhuizen Leuven

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

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.

View trial on ClinicalTrials.gov