A Randomised study comparing Lutetium-177 versus Apalutamide/Enzalutamide/Abiraterone, in metastatic Hormon Sensitive Prostate Cancer in PSMA positive patients.
Key facts
- Where
- Umea, SvédországSee the site
- Phase
- 3. fázis
Where in Svédország
- Region VaesterbottenUmea, SvédországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Region Västerbotten
- Trial code
- EU 2022-500570-33-00
- Record updated
- 2024. december 2.
- Original description
The primary objective of this trial is to demonstrate superiority in progression free survival for 177Lu-PSMA-I&T versus Apalutamide/Enzalutamide/Abiraterone Acetate. (Radiographic, clinical, or PSA progression-free survival).Read full original descriptionShow less
A Randomised, Open Label, Phase III, Multicenter, 2-arm study comparing 177Lu-PSMA-I&T versus Apalutamide/Enzalutamide/Abiraterone, in metastatic Hormon Sensitive Prostate Cancer Patients receiving castration treatment
The primary objective of this trial is to demonstrate superiority in progression free survival for 177Lu-PSMA-I&T versus Apalutamide/Enzalutamide/Abiraterone Acetate. (Radiographic, clinical, or PSA progression-free survival).
Inclusion: Histological or cytological proven prostate adenocarcinoma; Metastatic HSPC with measurable or evaluable disease; Patients must have evidence of PSMA-positive disease as seen on a [18F]PSMA-1007 or [68]Ga-gozetotide PET/CT scan; Patients included in the study that have fertile female partners must use adequate contraception, i.e. condom, within their relationship from start of the trial until 3 months after the last dose; Age ≥ 18 years; ECOG 0- 2; Estimated survival ≥ 3 months; Not eligible for triple therapy with Docetaxel; WBC 2000/mm3, neutrophils ≥1500/mm3, platelets ≥100,000/mm3; Satisfactory liver function: bilirubin, transaminases ≤ 1.5 times the upper limit of normal; Satisfactory renal function: Serum creatinine <1.5 x ULN (150 mmol/l). If creatinine 1.0 – 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance >60 mL/min are accepted in the study. (For calculation see https://www.qxmd.com/calculate-online/nephrology/ckd-epi-egfr); Patient information and signature of informed consent.
Exclusion: Prior treatment with second generation anti-androgen; Prior treatment with chemotherapy; Prior treatment with radiopharmaceutical agents for prostate cancer; Concurrent treatment with drugs decreasing the seizure threshold and/or cause seizure; Active infection or other serious underlying pathology that could prevent patients from receiving treatment; Patient participating in another clinical trial protocol with a molecule during this experimental study or treated four weeks prior to randomization; Systemic treatment with high dose steroids; Prior treatment with ADT, Bicalutamide or Abiraterone acetate; Cardiovascular disease (severe symptomatic coronary artery disease, congenital heart failure, class 3 and 4 of the NYHA); Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus); Uncontrolled hypertension (systolic bloodpressure >160 mmHg or diastolic blood pressure >100 mmHg); Subjects with hypersensitivity or contraindications to Apalutamide, Enzalutamide and/or Abiraterone acetate, according to the SmPC, should not be included in the study; History of cancer within 5 years before inclusion in the study other than basal cell or squamous cell skin cancer adequately treated; Any severe acute or chronic medical condition which would impair the ability of the patient to participate to the study or interfere with interpretation of study results, or patient unable to comply with the study procedures; Inadequate organ and bone marrow function as evidenced by: Hemoglobin <10.0 g/dL Absolute neutrophil count <1.5 x 10^9/L, Platelet count <100 x 10^9/L, AST and/or ALT >1.5 x ULN; Total bilirubin >1.5 x ULN, Serum creatinine >1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance <60 mL/min should be excluded (see http://www.qxmd.com/calculate-online/nephrology/ckd-epi-egfrfor for calculation); Brain metastases, uncontrolled symptomatic or asymptomatic.