Health Condition 1: C61- Malignant neoplasm of prostate
Conditions
Interventions
Intervention1: 161 Terbium PSMA radioligant therapy (161Tb PSMA): Patients will receive 1 cycle of 161Tb PSMA 617 (135-150
mCi) via IV infusion over 10-15 minutes under proper
radiation safety protoco
Sponsors
Mr Sunil K Gupta
Eligibility
Inclusion criteria
Inclusion criteria: 1. Biopsy proven adenocarcinoma of the prostate 2. Patients underwent radical surgery or radiotherapy as primary treatment 3. Fulfils the definition of biochemical recurrence a) For patients who have undergone radical prostatectomy 2 consecutive PSA values >0.2 ng/ml b) For patients who undergone radical radiotherapy, PSA elevation>2 ng/ml above the PSA nadir or absolute PSA value >1.5 ng/ml in two consecutive PSA measurements 4. Negative 68Ga PSMA PET/CT for recurrence
Exclusion criteria
Exclusion criteria: 1. Neuroendocrine/small cell differentiation in biopsy samples, at the time of diagnosis 2. Poor renal function serum creatinine greater than 1.6mg/dl or a creatinine clearance lesser than 40 ml/min. 3. Compromised bone marrow function-a) Hemoglobin level lesser than 9 g/dl b) Platelets less than 1,00,000 per cubic milliliter c) WBC count less than 2000 millilitre. 4. Compromised liver function -Total bilirubin level more than 1.5 times the normal 5. Patient has received chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSA50 response rate: It is defined as a PSA reduction of 50 percentage or more from pre-treatment value done after 6 weeks from the treatment, maintained on two evaluations at least 3 weeks apart.Timepoint: PSA50 response rate: It is defined as a PSA reduction of 50% or more from pre-treatment value done after 6 weeks from the treatment, maintained on two evaluations at least 3 weeks apart. | — |
Secondary
| Measure | Time frame |
|---|---|
| a)PSA progression free survival: PSA progression will be defined as a rise of greater than 25% above either the pretreatment level or the nadir PSA level (whichever is lowest) b)Metastasis-free Survival (MFS): MFS will be defined as the duration of time in months between patient recruitment and the earliest objective evidence of radiographic progression c)Adverse effect estimation: All toxicities will be evaluated with the help of CTCAE version 5.0.Timepoint: a) For PSA progression free survival and metastasis free survival: Till two years from the dtae of treatment b) Adverse effect estimation: Week 2, week 4, week 6, week 12 and week 24 from the date of treatment | — |
Countries
India
Contacts
Public ContactSayak Choudhury
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
Outcome results
None listed