Health Condition 1: C61- Malignant neoplasm of prostate
Conditions
Interventions
Intervention1: Lutetium 177 PSMA Radioligand Therapy: 177Lu PSMA 6 GBq/ cycle up to 4 cycles 8 weeks apart
Control Intervention1: Docetaxel: Docetaxel 75 mg/m2 up to 10 cycles 3 weeks apart
Sponsors
Postgraduate Institute of Medical Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: 1.Biopsy proven adenocarcinoma prostate 2.Castration resistant prostate cancer defined by castrate serum testosterone a.Biochemical progression: Three consecutive rises in PSA one week apart, resulting in two 50% increases over the nadir, and PSA >2 ng/ml. b.Radiologic progression: The appearance of new lesions: either two or more new bone lesions on bone scan or a soft tissue lesion using the Response Evaluation Criteria in Solid Tumours. 3.Metastatic disease (as established by 68Ga â?? PSMA PET/CT) 4.Significant PSMA expression in 68Ga â?? PSMA PET/CT defined as SUVmax of lesion being significantly (1.5 x) greater than that of normal liver and/or SUVmax of >=10 5.Chemotherapy naive patients; patients with prior treatment of new generation antiandrogens will however be included 6.ECOG performance 0-2 7.Adequate renal function â?? GFR >= 40 mL/min (as estimated by 99mTc DTPA GFR) 8.Stable haematological parameters: a.Hb >= 9 g/dL b.Neutrophils >= 1500/mcL c.Platelets >= 75000/mcL 9.Adequate liver function: a.Bilirubin b.AST or ALT c.Albumin >= 2.5 g/dL
Exclusion criteria
Exclusion criteria: 1. Prostate cancer with sarcomatous/spindle cell/small cell differentiation 2. PSMA expression in 68Ga â?? PSMA PET/CT, SUVmax 3. Sjogren Syndrome 4. Prior treatment with Docetaxel/Cabazitaxel/Lu PSMA 5. Active malignancy other than prostate cancer 6. Concurrent illness, including severe infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSA response rate (% of patients with PSA decline â?¥50%)Timepoint: 177Lu PSMA: assessed at 6 weeks following 2nd cycle and end of treatment Docetaxel: assessed at 3 weeks following 5 cycles and end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival rateTimepoint: Assessed at 1 year and 2 years post first cycle;Quality of life using NCCN FACT FPSI 17 (Version 2)Timepoint: Assessed at every visit;Radiological Response (68Ga PSMA PET) Timepoint: 177Lu PSMA: assessed at 6 weeks following 2nd cycle and end of treatment Docetaxel: assessed at 3 weeks following 5 cycles and 4-6 weeks after end of treatment ;Toxicity using CTCAE version 5.0Timepoint: Assessed at every visit | — |
Countries
India
Contacts
Public ContactDr Swayamjeet Satapathy
Postgraduate Institute of Medical Education and Research Chandigarh
Outcome results
None listed