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

NCT03454750 | Completed Phase 2

• 1 other identifier: IRST185.03
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Metastatic castration resistant prostate cancer; 68Ga-PSMA PET/CT positive

Outcome Measures

Primary Outcomes (2)

• Disease Control Rate (DCR )

  DCR is defined as the percentage of patients who have achieved complete response, partial response and stable disease lasting for at least 6 months from therapy start. DCR will be evaluated using the new international criteria proposed by the Version 1.1 Response Evaluation Criteria in Solid Tumors (RECIST).

  up to 36 months

• Incidence of Treatment-Emergent Adverse Events

  The evaluation of the Incidence of Treatment-Emergent Adverse Events starts from the 1st treatment until 30 days after the last treatment cycle; Treatment-Emergent Adverse Events are evaluated according to version 4.03 CTC-AE criteria.

  up to 30 days after the last treatment cycle

Secondary Outcomes (2)

• Progression free survival (PFS)

  up to 36 months

• Overall survival (OS)

  up to 36 months

Study Arms (1)

177Lu-PSMA

EXPERIMENTAL

177Lu PSMA

Drug: 177Lu-PSMA

Interventions

177Lu-PSMA DRUG

177Lu-PSMA 3.7-5-5 GBq Intravenous Slowly in 15-30 ' Day 1/ every 8-12 weeks Four cycles every 8-12 weeks

177Lu-PSMA

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male, Age \> 18 years.
• Patients must have histologically or cytologically confirmation of advanced prostate cancer castration resistant defined according to PCWG3 criteria
• Measurable disease according to RECIST 1.1. criteria; also patients with bone lesions only could be enrolled
• 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)
• 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)
• Concomitant LHRH analogs assumption is allowed
• Life expectancy greater than 6 months.
• ECOG performance status \<2
• 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).
• Participant is willing and able to give informed consent for participation in the study
• 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).

You may not qualify if:

• Patients treated with chemotherapy and 223Ra radiotherapy within 4 weeks and treated within 2 weeks with palliative radiotherapy.
• 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)
• ECOG performance status \>2
• Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
• 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.
• Assessed bone marrow invasion \> 50%

Sponsors & Collaborators

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

Study Sites (1)

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

Meldola, FC, 47014, Italy

Location

Related Publications (2)

• De Giorgi U, Sansovini M, Severi S, Nicolini S, Monti M, Gurioli G, Foca F, Casadei C, Conteduca V, Celli M, Di Iorio V, Calistri D, Matteucci F, von Eyben FE, Attard G, Paganelli G. Circulating androgen receptor gene amplification and resistance to 177Lu-PSMA-617 in metastatic castration-resistant prostate cancer: results of a Phase 2 trial. Br J Cancer. 2021 Oct;125(9):1226-1232. doi: 10.1038/s41416-021-01508-5. Epub 2021 Jul 31.

  PMID: 34333554 DERIVED

• Paganelli G, Sarnelli A, Severi S, Sansovini M, Belli ML, Monti M, Foca F, Celli M, Nicolini S, Tardelli E, Marini I, Matteucci F, Giganti M, Di Iorio V, De Giorgi U. Dosimetry and safety of 177Lu PSMA-617 along with polyglutamate parotid gland protector: preliminary results in metastatic castration-resistant prostate cancer patients. Eur J Nucl Med Mol Imaging. 2020 Dec;47(13):3008-3017. doi: 10.1007/s00259-020-04856-1. Epub 2020 May 20.

  PMID: 32430583 DERIVED

Study Officials

• Giovanni Paganelli

  IRST IRCCS

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 6, 2018
• Study Start: October 25, 2022
• Primary Completion: May 22, 2024
• Study Completion: May 22, 2024
• Last Updated: January 8, 2025

Record last verified: 2025-01

Locations

IT (1)