Health Condition 1: C61- Malignant neoplasm of prostate
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Sponsors
ACTREC Tata Memorial Centre (Intramural)
Eligibility
Inclusion criteria
Inclusion criteria: Participants meeting all of the following criteria will be included in the study: 1. Male patients, aged 18 years or more. 2. Diagnosis of metastatic castration-resistant prostate cancer (mCRPC). 3. ECOG 0-2 4. Scheduled to receive treatment with 177Lu-PSMA. 5. PSMA-positive disease confirmed by imaging (e.g., 68Ga-PSMA PET/CT). 6. Adequate organ function (hematologic, renal, hepatic) as per institutional criteria for 177Lu therapy. 7. Willingness to provide written informed consent before study participation.
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria will be excluded from the study: 1. Receipt of any systemic cytotoxic chemotherapy (other than docetaxel) within 30 days prior to the 177Lu baseline sample. 2. Prior treatment with any radiopharmaceutical within the last 6 months. 3. Ongoing high-dose corticosteroid therapy (prednisone more than 10 mg per day or equivalent for more than or equal to 7 consecutive days within 14 days before baseline sampling), except for the physiologic dose accompanying Abiraterone. 4. Patients with known co-existing metabolic or systemic disorders such as uncontrolled diabetes, untreated thyroid disorders, uncontrolled hypertension or hypotension, significant liver dysfunction, or impaired kidney function or obesity will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome: Identification of differential plasma metabolomic signatures at baseline and early post-treatment (Week 2 4) that distinguish responders (PSA50 at Week 12) from non-responders.Timepoint: From baseline to 12 weeks post-treatment, including intermediate timepoints at Week 2, and Week 4. | — |
Secondary
| Measure | Time frame |
|---|---|
| Temporal trajectory of metabolomic changes across all timepoints Identification of altered metabolic pathways (lipid, amino acid, glucose metabolism) Correlation between metabolomic profiles and PSA kinetics Identification of metabolomic predictors of toxicity Comparative metabolomic profiling between responders and non-respondersTimepoint: Up to 12 weeks following 177Lu-PSMA therapy, with additional follow-up as per clinical practice. | — |
Countries
India
Contacts
Public ContactDr Manjunath Nookala
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre
Outcome results
None listed