Metastasis-directed Therapy in Oligoprogressive Castration-refractory Prostate Cancer

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

Evaluation of the impact of metastasis-directed therapy in patients with castration-refractory prostate cancer and a maximum of 5 progressive lesions.

Eligibility criteria

Qualifiers

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 both) in any organ. Nodal (N1) disease should be measured in the short axis. Nodes more than 1.5 cm in the short axis are considered pathologic and measurable. Oligoprogression on bone scan is defined as the occurrence of maximal 3 new and/or progressive lesions. In case of not unambiguously, additional imaging such as diagnostic magnetic resonance imaging (MRI) or dedicated CT-scan should be performed. Visceral disease reported separately (lung, liver, adrenal, or CNS) and is considered measurable if an individual lesions is more than 1 cm longest dimension.

Patients with oligoprogressive disease with pADT only as ongoing treatment (Type 1).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Radiotherapy
  • metastasectomy

Treatment groups

246 Participants
are divided into 2 treatment groups