Health Condition 1: C61- Malignant neoplasm of prostate
Conditions
Interventions
Intervention1: Concomitant 177Lu-PSMA plus ADT: 177Lu-PSMA intravenously approximately 7.4 GBq (200 mCi) per cycle and 2 cycles at 6 weekly intervals with concomitant androgen deprivation therapy
Cont
Sponsors
Post Graduate Institute of Medical Education and Research Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: Biopsy proven adenocarcinoma prostate High volume metastatic disease (as established by 68Ga â?? PSMA PET/CT) defined as presence of visceral metastasis or >=4 bone lesions with at least 1 lesion beyond the vertebral bodies and pelvis Significant PSMA expression in 68Ga â?? PSMA PET/CT defined as SUVmax of lesion being greater than that of normal liver ECOG performance 0-2 Adequate renal function â?? eGFR >= 30 mL/min Stable haematological parameters: Hb >= 8 g/dL Neutrophils >= 1500/mcL Platelets >= 75000/mcL Adequate liver function: Bilirubin AST or ALT Albumin >= 2.5 g/dL
Exclusion criteria
Exclusion criteria: Prostate cancer with sarcomatous/spindle cell/small cell differentiation PSMA expression in 68Ga â?? PSMA 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 Patients with CR after ADT and docetaxel will be excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving serum prostate specific antigen (PSA) â?¤ 0.2 ng/mLTimepoint: 6 months from the date of randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Health related quality of life assessed using NCCN FACT FPSI-17 questionnaireTimepoint: Prior to initiation of post-docetaxel consolidated treatment, then every 6 weeks for two instances followed by once every 3 months till 12 months after enrolment;Overall Survival (OS)Timepoint: To be measured from the date of enrolment to the date of death due to any cause;Proportion of serious adverse events, assessed using CTCAE version 5.0Timepoint: After the initiation of post-docetaxel consolidated treatment, assessed every 3 weeks till 12 weeks, then 3 monthly till 12 months after enrolment;PSA-progression free survival (PSA-PFS) PSA progression is defined as per PCWG-3 Criteria as a rise in PSA by more than 25% AND more than 2ng/mL above the nadir; to be confirmed by a repeat PSA at least 3 weeks later. Early rises in PSA prior to 12 weeks of initiation of post-docetaxel treatment will be disregarded in determining PSA progression.Timepoint: Follow-up till 2 years after enrolment of last patient To be measured from the date of enrolment to the first date of evidence of PSA progression or date of death due to any cause;Radiological-PFS (rPFS) Radiological progression will be assessed as per the RECIST1.1 for soft tissue lesions and PCWG3 for bone lesionsTimepoint: Follow-up till 2 years after enrolment of last patient To be measured from the date of enrolment to the first date of evidence of radiological progression or date of death due to any cause;Time to development of castration resistance between treatment arms Castration resistance is defined as rising PSA and/or radiographic progression despite castrate levels of testosterone (â?¤ 50ng/dL or â?¤ 1.73nmol/L). Timepoint: Follow-up till 2 years after enrolment of last patient To be measured from the date of enrolment to the first date of evidence of castration resistance | — |
Countries
India
Contacts
Public ContactAshwani Sood
Postgraduate Institute of Medical Education and Research Chandigarh
Outcome results
None listed