Prostate cancer
Conditions
Brief summary
The feasibility and safety of drug application in patients with bone metastatic, oligometastatic, HSPCa after curative therapy (i.e., radical prostatectomy) treated by alternated Radium-223 RLT and 177Lu-PSMA RLT., The proposed treatment schedule is considered unfeasible when treatment is postponed more than 4 weeks in more than 50% of participants due to treatment related toxicity (myelosuppression or xerostomia), or when treatment had to be cancelled due to unwillingness of patients to continue (or complete) treatment.
Detailed description
The tolerability (toxicity) of study medication (i.e., Ra-223 RLT and 177Lu-PSMA RLT), the health-related quality of life (HRQoL) and the incidence of xerostomia by patient reported outcome measures (PROMS) using the RAND-36 and the xerostomia inventory, at baseline and repeatedly each two weeks after initiation of 177Lu-PSMA RLT and after the last treatment., the prostate-specific antigen (PSA) free survival at 3,6 and 12 months after combined cytotoxic RLT, i.e., 177Lu-PSMA RLT and Radium-223 RLT., the radiological response on PSMA PET/CT, bone scan and CT abdomen and thorax performed three months after last treatment (± 3 weeks).
Interventions
DRUGLutetium Lu-177 PSMA I&T Injection
Sponsors
Amsterdam UMC Stichting
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility and safety of drug application in patients with bone metastatic, oligometastatic, HSPCa after curative therapy (i.e., radical prostatectomy) treated by alternated Radium-223 RLT and 177Lu-PSMA RLT., The proposed treatment schedule is considered unfeasible when treatment is postponed more than 4 weeks in more than 50% of participants due to treatment related toxicity (myelosuppression or xerostomia), or when treatment had to be cancelled due to unwillingness of patients to continue (or complete) treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| The tolerability (toxicity) of study medication (i.e., Ra-223 RLT and 177Lu-PSMA RLT), the health-related quality of life (HRQoL) and the incidence of xerostomia by patient reported outcome measures (PROMS) using the RAND-36 and the xerostomia inventory, at baseline and repeatedly each two weeks after initiation of 177Lu-PSMA RLT and after the last treatment., the prostate-specific antigen (PSA) free survival at 3,6 and 12 months after combined cytotoxic RLT, i.e., 177Lu-PSMA RLT and Radium-223 RLT., the radiological response on PSMA PET/CT, bone scan and CT abdomen and thorax performed three months after last treatment (± 3 weeks). | — |
Countries
Netherlands
Outcome results
None listed