Prostate cancer. Malignant neoplasm of prostate
Conditions
Interventions
Intervention 1: Intervention Arm:Lu-177 PSMA Radioligand TherapyMedication and Dose:Lu-177 PSMA-617 administered intravenously (IV) at the standard dose of 7.4 GBq (200 mCi) every 6 weeksDose may be a
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
Male
Age
55 Years to 70 Years
Inclusion criteria
Inclusion criteria: Confirmed pathologic diagnosis of prostate adenocarcinoma Age >= 55 or (>= 50 to increase clinical inclusion ) Life expectancy >=12 month(at least 6 months for advanced cases) ECOG 0-2 Lab data :Hb = ? g/dL WBC = ? × 10^9/L? ANC = ?.? × 10^9/L? PLT = ??? × 10^9/LGFR = ?? mL/min AST/ALT = ?× ULN level testosterones =?? ng/dL during ADT Disease condition: recurrence : PSA doubling time (PSADT) liver, lesion without uptake- PSMA-negative, short axis =?.? cm ? uptake < liver, metastase visceral =?.? cm ? uptake < liver, bone lesion with soft tissue =?.? cm ? uptake < liver letter of satisfaction :sign advisedly
Exclusion criteria
Exclusion criteria: Recent systemic therapies without a washout period :ADT within the past 4 weeks Chemotherapy within the past 6 weeks Radiopharmaceuticals (Ra-223 or Lu-177) within the past 6 month Extensive metastatic disease :More than 5 metastatic lesions or symptomatic brain metastasis Other malignancies: Presence of an active malignancy other than non-melanoma skin cancer (BCC/SCC) Unstable underlying conditions:Severe cardiac, pulmonary, or infectious disease Psychiatric or social conditions that interfere with adherence to treatment or follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSA Response. Timepoint: Before starting treatment – Interim assessment (after two cycles) – End of treatment (after completion of the cycles). Method of measurement: Complete reduction of PSA to a level <0.2 ng/mL ? Complete Response (CR)Reduction =50% compared to baseline ? Partial Response (PR).;Psa dynamics. Timepoint: Before starting treatment – Interim assessment (after two cycles) – End of treatment (after completion of the cycles). Method of measurement: PSADT (PSA Doubling Time) or PSAV (PSA Velocity) are evaluated as prognostic indicators.;Radiologic response. Timepoint: Before starting treatment – Interim assessment (after two cycles) – End of treatment (after completion of the cycles). Method of measurement: Change in lesion size on CT and MRI based on RECIST v1.1Bone lesions on Bone Scan, PSMA PET/CT, and PSMA-Tc99m SPECT/CT based on PCWG3.;TTNT (Time to Next Treatment). Timepoint: Before starting treatment – Interim assessment (after two cycles) – End of treatment (after completion of the cycles). Method of measurement: Time from study initiation to the need for new systemic therapy (ADT or chemotherapy) ? Primary endpoint.;Quality of Life (QoL). Timepoint: Before starting treatment – Interim assessment (after two cycles) – End of treatment (after completion of the cycles). Method of measurement: Assessment with EORTC QLQ-C30 and QLQ-PR25 at baseline and during longitudinal follow-up; analysis of QoL changes using longitudinal statistical models.;Need for analgesics. Timepoint: Before starting treatment – Interim assessment (after two cycles) – End of treatment (after completion of the cycles). Method of measurement: Documentation of analgesic medications and pain intensity based on the Numerical Rating Scale (NRS).;Safety and adverse events. Timepoint: Before starting treatment – Interim assessment (after two cycles) – End of treatment (after completion of the cycles). Method of measurement: Documentation and grading according to CTCAE v5.0, including | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNaghmeh Ramezani
Tabriz University of Medical Sciences
Outcome results
None listed