Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2017-001395-38-IT
EUCTR2017-001395-38-IT
Active, not recruiting
Phase 1

Treatment of Metastatic prostate cancer castration resistant (mCRPC) with 223RaCl2: response evaluation with a novel tracer 68Ga-PSMA PET molecular imaging - CALIPSO

AZIENDA USL DELLA VALLE D'AOSTA0 sites50 target enrollmentNovember 5, 2020
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsPatients mCRPC eligible to treatment with 223RaCl2MedDRA version: 21.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10005993Term: Bone metastasesSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.1Level: LLTClassification code 10036223Term: Positron emission tomographySystem Organ Class: 100000004848MedDRA version: 21.1Level: PTClassification code 10062904Term: Hormone-refractory prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Patients mCRPC eligible to treatment with 223RaCl2
Sponsor
AZIENDA USL DELLA VALLE D'AOSTA
Enrollment
50
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 5, 2020
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Male

Investigators

Sponsor
AZIENDA USL DELLA VALLE D'AOSTA

Eligibility Criteria

Inclusion Criteria

  • •2\.Ability to provide informed written consent. All subjects must sign an informed consent form indicating their understanding investigational nature of study
  • •3\.Histologically or cytologically confirmed adenocarcinoma of the prostate
  • •4\.Known hormone refractory disease (castrate serum testosterone level: \=50 ng/dL)
  • •5\.Multiple skeletal metastases (\= 2 hot spots) on bone scintigraphy within 4 weeks
  • •6\.Bone pain (Brief Pain Inventory BPI\-SF \= 2 )
  • •7\.ECOG Performance status (PS): 0\-2
  • •8\.Acceptable haematology and serum biochemistry screening values as follows: WBC\= 3000/mm3 , ANC\= 1500/mm3, PLT\= 100000/mm3 , Hb\= 10 g/dl, Total bilirubin \= 2\.0 mg/dL, ALT and AST \= 2\.5 x the upper limit of normal, Serum creatinine \<1\.5 x the upper limit of normal
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

  • •1\.Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc) or to complete the needed investigational due to others reasons (severe claustrophobia unresponsive to oral anxiolytics, radiation phobia, etc)
  • •2\.Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET scanner due to BMI
  • •3\.Visceral metastases assessed by thorax and abdominal/pelvic CT within previous 8 weeks
  • •4\.Malignant lymphoadenopathy exceeding 3 cm in short axis diameter assessed by thorax and abdominal/pelvic CT within previous 8 weeks
  • •5\.Patients with known inflammatory bowel disease (IBD)
  • •6\.Patients with known osteonecrosis of the jaw (ONJ)
  • •7\.Partecipation in another clinical trial with any investigational agents within 4 weeks prior to study screening or within five half\-lives of the drug
  • •8\.Concomitant chemotherapy, abiraterone or enzalutamide therapy

Outcomes

Primary Outcomes

Not specified

Similar Trials

Recruiting
Phase 2
Treatment of patients with castration-resistant metastatic prostate cancer with nuclear medicine procedureCastration resistant metastatic prostate cancer.Malignant neoplasm of prostate
IRCT20180113038331N1Mashhad University of Medical Sciences20
Completed
Phase 1
Radionuclide therapy using Lutetium-177 prostate specific membrane antigen (PSMA): a pilot study in men with castrate-resistant prostate cancer (LuPSMA trial)Prostate CancerCancer - Prostate
ACTRN12615000912583Peter MacCallum Cancer Centre30
Completed
Not Applicable
Transmurale zorg Prostaatkanker, van diagnose tot en met nazorgProstate cancer, transmural care, decision aid, SDM, Follow-up care, Substitution, Family doctors or General practitioners, Prostaatkanker, Keuzehulp, Samenwerking tussen eerste lijn en tweede lijn.
NL-OMON22953Initiator: Catharina Wilhelmina Hospital (CWZ)NijmegenPrimary Sponsor/Performer: Radboud University Nijmegen Medical centerOther performers: CWZ in Nijmegen, Maashospital Pantein in Boxmeer200
Active, not recruiting
Phase 1
STAMPEDE: Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy
EUCTR2004-000193-31-GBniversity College London12,000
Active, not recruiting
Phase 1
Treatment Of Metastatic Bladder cancer at the time Of biochemical reLApse following radical cystectomy - TOMBOLArothelial cancerTherapeutic area: Diseases [C] - Male Urogenital Diseases [C12]Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
CTIS2024-510865-41-00Aarhus Universitetshospital282