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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Radiotherapy
RadiationProgression-directed therapy (stereotactic body radiation therapy)
metastasectomy
Procedure/SurgeryProgression-directed therapy (metastasectomy)
Treatment groups
246 Participants
are divided into 2 treatment groupsGroup A: Standard of care therapyNo intervention 0 interventions
Group B: Progression-directed therapyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Overall Survival
Overall Survival
Time frame
will be calculated from the day of randomisation until death from any cause, wichever came first, assessed up to 5 years.Secondary outcomes
1
Quality of life scoring EORTC QLQ-C30
Quality of life scoring using the EORTC QLQ-C30
Time frame
Assessments are planned at baseline and during follow-up consultation at month 1, month 3, month 6, month 12 and month 242
Quality of life scoring EORTC QLQ-PR25
Quality of life scoring using the EORTC QLQ-PR25
Time frame
Assessments are planned at baseline and during follow-up consultation at month 1, month 3, month 6, month 12 and month 243
Quality of life scoring EQ-5D-5L
Quality of life scoring using the EQ-5D-5L.
Time frame
Assessments are planned at baseline and during follow-up consultation at month 1, month 3, month 6, month 12 and month 244
Cancer Specific Survival
Cancer Specific Survival
Time frame
will be calculated from the day of randomisation until prostate cancer death, assessed up to 5 years.Sponsors and contacts
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Source ClinicalTrials.gov