Prostate cancer
Conditions
Brief summary
Incidence of DLTs after first treatment administration (DLT evaluation period).
Detailed description
TEAEs and TRAEs, including laboratory results, at each activity level and overall., Ability to perform prostatectomy after start of neoadjuvant treatment, duration of surgery, complication rate during and after surgery and grade of surgical difficulty., Tumour absorbed doses and absorbed doses of organs at risk assessed by imaging dosimetry and blood dosimetry after each patient’s first administration of TRP-001., Treatment efficacy will be explored based on the following: o Biochemical response rate during treatment period and up to immediately before RPE o Objective response rate from baseline to before RPE o Pathological response rate in the resected surgical specimen of the primary tumour within the prostate gland and in involved LNs, if any.
Interventions
None listed
Sponsors
Torpedo Pharmaceuticals AG
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of DLTs after first treatment administration (DLT evaluation period). | — |
Secondary
| Measure | Time frame |
|---|---|
| TEAEs and TRAEs, including laboratory results, at each activity level and overall., Ability to perform prostatectomy after start of neoadjuvant treatment, duration of surgery, complication rate during and after surgery and grade of surgical difficulty., Tumour absorbed doses and absorbed doses of organs at risk assessed by imaging dosimetry and blood dosimetry after each patient’s first administration of TRP-001., Treatment efficacy will be explored based on the following: o Biochemical response rate during treatment period and up to immediately before RPE o Objective response rate from baseline to before RPE o Pathological response rate in the resected surgical specimen of the primary tumour within the prostate gland and in involved LNs, if any. | — |
Outcome results
None listed