A randomized phase I/II study of neoadjuvant treatment with 177-Lutetium-PSMA-617 with or without Ipilimumab in subjects with very high-risk prostatecancer who are candidates for radical prostatectomy (NEPI Trail) - CA184-608

niversitaetsklinikum Essen AöR0 sites58 target enrollmentJuly 5, 2024

ConditionsPatients 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.Therapeutic area: Diseases [C] - Male Urogenital Diseases [C12]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: 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.
Sponsor: niversitaetsklinikum Essen AöR
Enrollment: 58
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 5, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Investigators

Sponsor

niversitaetsklinikum Essen AöR

Eligibility Criteria

Inclusion Criteria

•Must be \=18 years of age, Sexually active patients must use a condom to prevent them from fathering a child and to prevent delivery of study treatment via seminal fluid to their partner for at least 14 weeks after the last dose of \[177Lu]Lu\-PSMA\-617, Tumor tissue of both prostate biopsy and radical prostatectomy specimen available for local histology review and reference pathology by Professor Henning Reis (Department of Pathology, University Hospital Frankfurt), Signed an informed consent form (ICF) indicating that the participant understands the purpose of and procedures required for the study and is willing to participate in the study; participants must be willing and able to adhere to the prohibitions and restrictions specified in this protocol, Histologically confirmed adenocarcinoma of the prostate including following criteria: Very High\-risk defined by a total Gleason\-Score \=4\+4 (ISUP\-GG 4\+5\) and clinical stage cT3 (digital rectal examination or imaging based) plus clinical nodal status cN\+ or Serum\-PSA level \>20ng/ml, Exclusion of metastases (M0\) on conventional imaging and maximum oligometastatic status on PSMA PET imaging, Treatment naïve patients, Eastern Cooperative Oncology Group ECOG 0\-1, Candidate for radical prostatectomy with pelvic lymph node dissection as per the investigator, Patients must be PSMA Positron Emission Tomography (PET) scan positive with a prostatic SUVmax \> 12 (PRIMARY Score: 5\) ., Following laboratory criteria must be obtained within 14 days prior to randomization: ?Bone Marrow reserve •White blood cells, WBC \= 2000/µL •Neutrophils \= 1500/µL •Platelets \= 100 x103/µL •Hemoglobin \= 9\.0 g/dL ?Hepatic •AST/ALT \= 3 x ULN •Total Bilirubin \= 1\.5 x ULN (except participants with Gilbert Syndrome, who may have total bilirubin \< 3\.0 mg/dL) ?Renal •Serum creatinine \= 1\.5xULN ?Endocrine •TSH 0,4 \- 4,0 mU/l \= 0,4 \- 4,0 µU/ml oIf TSH is not in normal range, fT3 and fT4 must be determined ofT3 2,3 \- 4,5 pg/ml \= 3,5 \- 7,0 pmol/l ofT4 0,8 \- 1,8 ng/dl \= 8 \- 18 ng/l \= 10 \- 23 pmol/l ?Albumin \>3\.0 g/dL (3\.0 g/dL is equivalent to 30 g/L) ?Electrolytes: •Potassium: 3\.5\-5 mmol/L •Sodium: 135\-145 mmol/L ?Pancreatic: •amylase, lipase \= 3 x ULN ?alkaline phosphatase (range to be assessed in context of oligometastatic disease) ?blood sugar \< 200 mg/dL (11\.1 mmol/L)

Exclusion Criteria

•Distant metastasis (clinical stage M1\) on conventional imaging. Oligometastatic patients on exclusively PSMA PET imaging will not be excluded. Patients with PSA values below 20ng/ml and no evidence of nodal disease are excluded, Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy, Lack of availability for clinical follow\-up assessments, Other potential life\-threatening malignancies within the past five years requiring treatment, Serious cardiac, gastrointestinal, hepatic or pulmonary disease reducing life expectancy to less than five years, Patients with serious intercurrent illness, requiring hospitalization, Other serious illnesses, e.g., serious infections requiring antibiotics or bleeding disorders, Patients carrying organ transplants and/or receiving continuous immunosuppressive medication (other than steroid therapy of up to 10 mg prednisone per day), The patient is known to be positive for Human Immunodeficiency Virus (HIV) or other chronic infections (HBV, HCV) or has another confirmed or suspected immunosuppressive or immunodeficient condition, Known hypersensitivity reaction to any of the components of study treatment, Known alcohol or drug abuse, Prior treatment with androgen receptor antagonists. Treatment with GnRH analogs prior to ICF signature, Participation in another clinical study and use of any investigational or non\-registered product (drug or vaccine) other than the study treatment within the 30 days before registration, Significant disease or condition which, in the investigator’s opinion, would exclude the patient from the study, Legal incapacity or limited legal capacity, Bilateral orchiectomy, History of prior systemic or local therapy for prostate cancer, including pelvic radiation for prostate cancer, Use of any investigational agent \=4 weeks prior to randomization or any therapeutic procedure for prostate cancer at any time, Major surgery \=4 weeks prior to randomization, Prior therapy with CTLA4 antibodies, Previous treatment with any of the following within 6 months of randomization: ?Strontium\-89, Samarium\-153, Rhenium\-186, Rhenium\-188, Radium\-223, ?Previous PSMA\-targeted radioligand therapy, Any immunosuppressive therapy given within the past 30 days prior to study drug administration (excluding physiologic steroid hormone replacement and / or steroid therapy up to a maximum dose of 10 mg prednisone or equivalent per day)