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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03454750
Recruitment Status : Recruiting
First Posted : March 6, 2018
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

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

Condition or disease Intervention/treatment Phase
Metastatic Castration Resistant Prostate Cancer 68Ga-PSMA PET/CT Positive Drug: 177Lu-PSMA Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radiometabolic Therapy (RMT) With 177Lu PSMA 617 in Advanced Castration Resistant Prostate Cancer (CRPC): Efficacy and Toxicity Evaluation
Actual Study Start Date : April 19, 2017
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: 177Lu-PSMA
177Lu PSMA
Drug: 177Lu-PSMA
177Lu-PSMA 3.7-5-5 GBq Intravenous Slowly in 15-30 ' Day 1/ every 8-12 weeks Four cycles every 8-12 weeks




Primary Outcome Measures :
  1. Disease Control Rate (DCR ) [ Time Frame: up to 36 months ]
    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).

  2. Incidence of Treatment-Emergent Adverse Events [ Time Frame: up to 30 days after the last treatment cycle ]
    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.


Secondary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: up to 36 months ]
    PFS is defined as the time from the start treatment date to the date of first observation of documented disease progression or death due to any cause. Patients without tumor progression at the time of analysis will be censored at their last date of tumor evaluation.

  2. Overall survival (OS) [ Time Frame: up to 36 months ]
    Overall survival is defined as the time from the therapy start to the date of death due to any cause or the date of last contact (censored observation) at the date of data cut-off.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03454750


Contacts
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Contact: Oriana Nanni +390543739266 oriana.nanni@irst.emr.it

Locations
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Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) Recruiting
Meldola, FC, Italy, 47014
Contact: Giovanni Paganelli, MD    0543739100    giovanni.paganelli@irst.emr.it   
Sub-Investigator: Ugo De Giorgi, MD         
Sponsors and Collaborators
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Investigators
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Study Chair: Giovanni Paganelli IRST IRCCS
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
ClinicalTrials.gov Identifier: NCT03454750    
Other Study ID Numbers: IRST185.03
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori:
Metastatic castration resistant prostate cancer
68Ga-PSMA PET/CT positive
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases