Radiometabolic Therapy (RMT) With 177Lu PSMA 617 in Advanced Castration Resistant Prostate Cancer (CRPC) (LU-PSMA)

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

Status and phase: Completed; Phase 2

Conditions: Metastatic Castration Resistant Prostate Cancer; 68Ga-PSMA PET/CT Positive

Treatments: Drug: 177Lu-PSMA

Study type: Interventional

Funder types: Other

Identifiers

NCT03454750

IRST185.03

Details and patient eligibility

About

Radiometabolic Therapy (RMT) with 177Lu PSMA 617 in advanced castration resistant prostate cancer (CRPC): efficacy and toxicity evaluation

Full description

Radiometabolic Therapy (RMT) with 177Lu PSMA 617 in advanced castration resistant prostate cancer (CRPC): efficacy and toxicity evaluation. Single-center, prospective, non controlled, open label, phase II trial. The main objective of this study is to evaluate the Disease Control Rate (DCR) and the safety as co-primary objective.

The secondary objectives are: late toxicity, PFS, OS, biochemical response and dosimetry.

Enrollment: 143 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male, Age > 18 years.
2. Patients must have histologically or cytologically confirmation of advanced prostate cancer castration resistant defined according to PCWG3 criteria
3. Measurable disease according to RECIST 1.1. criteria; also patients with bone lesions only could be enrolled
4. Patients with documented disease will be admitted to therapeutic phase only if the diagnostic PET/CT 68Ga-PSMA images demonstrate a significant uptake (tumor to background ratio >2.5) at metastatic tumour site (or in the primary when present, or both)
5. Patients with documented radiological progression (in soft tissue and / or bone) and / or biochemical progression (sequence of 3 PSA rising values from a screening PSA value ≥ 2 ng / ml) according to PCWG3 in pre-study period, refractory or unfit to conventional standard treatments (hormonal or chemotherapeutic treatment such as abiraterone, enzalutamide and docetaxel)
6. Concomitant LHRH analogs assumption is allowed
7. Life expectancy greater than 6 months.
8. ECOG performance status <2
9. Adequate haematological, liver and renal function: haemoglobin >= 9 g/dL, absolute neutrophil count (ANC) >= 1.5 x 109 /L, platelets >= 100 x 109 /L, bilirubin ≤1.5 X upper normal limit (UNL), alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) <2.5 X UNL (< 5 X UNL in presence of liver metastases, creatinine < 2 mg/dL).
10. Participant is willing and able to give informed consent for participation in the study
11. Other known malignant neoplastic diseases in the patient's medical history with a disease-free interval of less than 3 years (except for previously treated basal cell carcinoma).

Exclusion criteria

1. Patients treated with chemotherapy and 223Ra radiotherapy within 4 weeks and treated within 2 weeks with palliative radiotherapy.
2. All acute toxic effects of any prior therapy (including surgery, radiation therapy, chemotherapy) must have resolved to a grade ≤ 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (CTCAE)
3. ECOG performance status >2
4. Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
6. Assessed bone marrow invasion > 50%

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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143 participants in 1 patient group

177Lu-PSMA

Experimental group

Description:

177Lu PSMA

Treatment:

Drug: 177Lu-PSMA