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Clinical Trials/EUCTR2016-002732-32-IT
EUCTR2016-002732-32-IT
Active, not recruiting
Phase 1

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

ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS0 sites210 target enrollmentSeptember 6, 2019
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Conditionsadvanced castration resistant prostate cancer (CRPC)MedDRA version: 20.0Level: LLTClassification code 10007453Term: Carcinoma of the prostate metastaticSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
advanced castration resistant prostate cancer (CRPC)
Sponsor
ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS
Enrollment
210
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 6, 2019
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Male

Investigators

Sponsor
ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS

Eligibility Criteria

Inclusion Criteria

  • •1\. Patients must have histologically or cytologically confirmed prostate cancer
  • •2\. Male, aged \= 18 years.
  • •3\. Metastatic castration resistant prostate cancer
  • •4\. 68Ga\-PSMA PET/CT positive in known site of disease, documented by CT or MRI or bone scan or 18Coline\-PET
  • •5\. Patients with clinical progression from previous treatment
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range: 1
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 60
  • •F.1\.3 Elderly (\>\=65 years) yes

Exclusion Criteria

  • •1\. Patients treated with chemotherapy and 223Ra radiotherapy within 4 weeks and treated within 2 weeks with palliative radiotherapy.
  • •2\. ECOG performance status \>2
  • •3\. Assessed bone marrow invasion \> 50%

Outcomes

Primary Outcomes

Not specified

Similar Trials

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Phase 1
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Radiometabolic Therapy (RMT) With 177Lu PSMA 617 in Advanced Castration Resistant Prostate Cancer (CRPC)Metastatic Castration Resistant Prostate Cancer68Ga-PSMA PET/CT Positive
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