Adenocarcinoma of the prostate prostate cancer
Conditions
Interventions
A maximum of 2 (expandable to 4 if clinically benefiting) cycles of 177Lu-PSMA
radioligand therapy (RLT).
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Histological proven adenocarcinoma of the prostate with archived tumor material. - Biochemical recurrence or clinical progression (PSA > 1.0 µg/l). - ECOG 0-1. - PSA-doubling time =1, maximally 5 metastases. - Local treatment for oligometastases with radiotherapy or surgery appears to be no option anymore (due to prior treatment or the location of the metastatic lesions). - No prior hormonal therapy (including any androgen directed treatment such as Bicalutamide, Apalutamide, Abiraterone or Enzalutamide) or taxane based chemotherapy (docetaxel or cabazitaxel); testosterone > 1.7 nmol/l. Exception: local prostate cancer treated with local radiotherapy plus adjuvant ADT; these patients need to be stopped with ADT at least 6 months. - No visceral metastases. - Laboratory values: • White blood cells > 3.0 x 10^9/l • Platelet count > 75 x 10^9/l • Hemoglobin > 6.2 mmol/l • ASAT, ALAT = 50 ml/min - Signed informed consent.
Exclusion criteria
Exclusion criteria: - A detectable lesion on the 18F-PSMA PET/CT with significant PSMA avidity, defined by a SUVmax > 10 (partial volume corrected). - A known subtype other than prostate adenocarcinoma. - Previous PSMA based radioligand treatment. - Visceral or brain metastases. - Any medical condition present that in the opinion of the investigator will affect patients* clinical status when participating in this trial. - Prior hip replacement surgery potentially influencing performance of PSMA PET/CT. - Sjogren's syndrome. - A second active malignancy other than prostate cancer. - Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main goal of this study is to assess the difference in the fraction of patients that have disease progression during the 6 month follow up of this study after 177Lu-PSMA RLT or a deferred androgen deprivation treatment schedule. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints will be the ADT free survival, PSA response, toxicity defined by NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0), radiological state of the disease expressed in the difference in amount and size of suspicious nodes 18F-PSMA PET/CT and (whole body) MRI between pre- and post-therapy and quality of life assessments. | — |
Countries
Netherlands
Outcome results
None listed