Patients with very high-risk prostate cancer (as defined by a total Gleason-Score ≥4+4 [ISUP-GG 4+5] and clinical stage cT3 (digital rectal examinations or imaging based) plus clinical nodal status cN+ or Serum-PSA level > 20 ng/ml who are candidates for radical prostatectomy with pelvic lymph node dissection.
Conditions
Brief summary
Feasibility will be defined as the ability to perform prostatectomy in at least 83,33 % of participants of a treatment arm 85 days after start of neoadjuvant treatment with a maximum delay by 3 weeks in the present study., Safety of neoadjuvant treatment with ipilimumab and [177Lu]Lu-PSMA-617 RLT before radical prostatectomy will be characterized according to Adverse Events and Serious Adverse Events measured using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
Detailed description
Clinical activity is measured by pathologic complete response (pCR) and minimal residual disease (MRD), which is defined as a tumor burden of 5 mm or less in the largest dimensions., Disease-free survival measurements are also performed. Disease-free survival is defined as PSA progression-free survival up to 1 year after prostatectomy.
Interventions
DRUGIpilimumab
Sponsors
Universitaetsklinikum Essen AöR
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility will be defined as the ability to perform prostatectomy in at least 83,33 % of participants of a treatment arm 85 days after start of neoadjuvant treatment with a maximum delay by 3 weeks in the present study., Safety of neoadjuvant treatment with ipilimumab and [177Lu]Lu-PSMA-617 RLT before radical prostatectomy will be characterized according to Adverse Events and Serious Adverse Events measured using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical activity is measured by pathologic complete response (pCR) and minimal residual disease (MRD), which is defined as a tumor burden of 5 mm or less in the largest dimensions., Disease-free survival measurements are also performed. Disease-free survival is defined as PSA progression-free survival up to 1 year after prostatectomy. | — |
Countries
Germany
Outcome results
None listed