metastatic prostate cancer oligoprogressive castraction resistant prostate cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • Adenocarcinoma of the prostate. • mCRPC setting, with testosterone level = 18 years old. • Patient should be presented at the multidisciplinary tumor board of the local hospital in which the therapy will be given. • Before patient registration, written informed consent must be given according to ICH/GCO and national/local regulations.
Exclusion criteria
Exclusion criteria: • Serum testosterone level > 50 ng/ml or > 1.7 nmol/l. • Presence of 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, except non-melanoma skin cancer or non-invasive urothelial cell carcinoma. • Local recurrence in the prostate after previous radiotherapy. • Previous treatments (RT, surgery) or comorbidities making new treatment with MDRT impossible. • Disorder precluding understanding of trial information or informed consent or signing informed consent. • Evidence of PSMA-negative disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • 6, 12-and 24-months NEST-FS. • 6- and 12- months rPFS. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Quality of Life (QoL) evaluated using the EORTC QLQ-C30 for health related QoL and the EORTC PR-25 for prostate symptom specific QoL. • Acute and late toxicity reported using both physician-reported score (CTCAE v5) and patient-reported questionnaires (RTOG/EORTC). • Overall survival (OS). | — |
Countries
Netherlands
Contacts
Universitair Medisch Centrum Groningen