Clinical trial NCT06449781: 177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High and Very High Risk Prostate Cancer
Official title: 177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High- and Very High-risk Prostate Cancer After Radical Treatment Using Locoregional Teleradiotherapy and Hormone Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-label, two-arm, randomized study.
Primary purpose: TREATMENT

Brief summary: Single-center, non-commercial phase 2 clinical trial to evaluate 177Lu-PSMA as a systemic adjuvant treatment in patients with high and very high risk prostate cancer after radical treatment using locoregional teleradiotherapy and hormone therapy

Detailed description: The intervention will consist of a single administration of 177Lu-PSMA in the research arm. Both the study and control groups will receive standard hormone therapy.

The study population includes 200 adult men with high-risk or very high-risk prostate cancer, with no signs of cancer dissemination in radiological examinations after completion of radiotherapy and continued hormone therapy

Participation time in the Study:

intervention phase - 1 day; observation phase - 5 years

Eligibility criteria: Inclusion Criteria:

* Giving a written informed consent
* Histopathologically confirmed high or very high risk prostate cancer
* Completion of radical locoregional treatment
* Completion of locoregional treatment within 3 months before inclusion to the study
* ECOG performance status 0 to 2
* Age over 18 years
* Within 28 days before entering the study, there were no signs of cancer dissemination documented in radiological tests
* Castrate testosterone level (testosteron \< 50 ng/dL lub 1,7 nmol/L)
* Patients with adequate function of main organs:

  * bone marrow:

    * neutrophils \> 1500x10\^9/L;
    * thrombocytes \> 100,000x10\^9/L;
    * hemoglobin \> 9 g/dL
  * liver:

    * bilirubin \< 2xULN (upper limit of normal) in patients with Gilbert's syndrome \< 5xULN;
    * aminotransferase \< 3xULN
  * kidneys:

    * eGFR \> 50 ml/min
    * albumin \>2.5 mg/ml
* For men of reproductive age: the need to use double barrier contraception

Exclusion Criteria:

* The presence of distant metastases confirmed by radiological examination
* Absence of approval to use effective contraception method
* Absence of Patient's consent to participate in the Study
* Urinary tract obstruction or/and hydronephrosis.
* Concurrent anticancer treatment.

Primary outcomes:
measure: Treatment effectiveness
timeFrame: 2 and 5 years after end of treatment
Secondary outcomes:
measure: Biochemical progression-free survival
timeFrame: During the intervention and follow up period (assessed up to 5 years)
measure: Radiological progression-free survival
timeFrame: During the intervention and follow up period (assessed up to 5 years)
measure: Time until the next therapeutic intervention
timeFrame: During the intervention and follow up period (assessed up to 5 years)
measure: Incidence of Treatment-Emergent Adverse Events according to CTCAE v 5.0
timeFrame: During the intervention and follow up period (assessed up to 5 years)
measure: Quliaty of life
timeFrame: During the intervention and follow up period (assessed up to 5 years)
Other outcomes:
Locations:
city: Gliwice
country: Poland
facility: Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
Study officials:
References: