Health Condition 1: C61- Malignant neoplasm of prostate
Conditions
Interventions
Intervention1: 177Lu-PSMA-617: 177Lu-PSMA-617 will be administered intravenously, approximately 7.4 GBq (200 mCi) per cycle and up to 4 cycles will be administered at 6 weekly intervals.
Control Inter
Sponsors
All India Institute of Medical Sciences New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: Histologically proven adenocarcinoma prostate High-volume metastatic disease (as established by 68Ga-PSMA-11 PET/CT) defined as presence of visceral metastasis or >=4 bone lesions with at least one extra-axial lesion Significant PSMA expression in 68Ga-PSMA-11 PET/CT defined as avidity of lesion being greater than that of normal liver ECOG performance 0-2 Adequate renal function â?? eGFR >= 30 mL/min Stable haematological parameters: oHb >= 8 g/dL oNeutrophils >= 1500/mcL oPlatelets >= 75000/mcL Adequate liver function: oBilirubin oAST or ALT oAlbumin >= 2.5 g/dL Prior treatments allowed: oFor de-novo mHSPC: prior ADT allowed if commenced within 90 days of randomization and no evidence of progressive disease; prior palliative radiotherapy or surgery allowed if conducted >=4 weeks prior to randomization oFor localized PCa progressing to mHSPC (all treatments completed >=6 months prior to randomization) ï?§ ï?§All other forms of prior therapies including radiation therapy, prostatectomy and lymph node dissection
Exclusion criteria
Exclusion criteria: Prostate cancer with sarcomatous/spindle cell/small cell differentiation PSMA expression in 68Ga-PSMA-11 PET/CT less than liver Sjogren Syndrome Active malignancy other than prostate cancer Concurrent illness, including severe infection Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception Prior treatment with docetaxel or novel anti-androgens
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSA complete response rate at 6 months Castration-resistance free survival rate at 2 yearsTimepoint: PSA follow-up every 3 weeks till 24 weeks, then every 4 weeks till 12 months, followed by every 12 weeks till 5 years Radiological follow-up every 3 months till 2 years after enrolment of last patient, then every 6 months till 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Molecular Response RateTimepoint: Assessed at 12 and 24 weeks after treatment initiation.;Objective Response RateTimepoint: Assessed at 12 and 24 weeks after treatment initiation.;Overall SurvivalTimepoint: To be measured from the date of randomization to death due to any cause;Proportion of serious and non-serious adverse events, assessed using CTCAE version 5.0Timepoint: Assessed every 3 weeks till 24 weeks, then 3 monthly till 12 months after treatment initiation.;PSA complete response rate at 12 monthsTimepoint: Proportion of patients achieving serum prostate specific antigen (PSA) â?¤0.2 ng/mL at 12 months from the date of treatment initiation. Patients with unequivocal radiological progression within 12 months of initiating treatment will be considered as not having complete PSA response at 12 months;PSA-progression-free survival (PSA-PFS)Timepoint: Follow-up every 3 weeks till 24 weeks, then every 4 weeks till 12 months, followed by every 12 weeks till 5 years. To be measured from the date of treatment initiation to the first date of evidence of PSA progression or date of death due to any cause. PSA progression will be defined as a rise in PSA by more than 25% and more than 2 ng/mL above the nadir; to be confirmed by a repeat PSA at least 3 weeks later.;Radiological-PFS (rPFS)Timepoint: Follow-up every 3 months till 2 years after enrolment of last patient, then every 6 months till 5 years. To be measured from the date of treatment initiation to the first date of evidence of radiological progression or date of death due to any cause. Radiological progression will be assessed as per the RECIST1.1 for soft tissue lesions and PCWG3 for bone lesions.;Time to deterioration in health-related quality-of-lifeTimepoint: Assessed every 12 weeks after treatment initiation till 12 months, then every 6 months till 5 years. | — |
Countries
India
Contacts
Public ContactSwayamjeet Satapathy
All india Institute of Medical Sciences New Delhi
Outcome results
None listed