Adding injectable radioactive therapy (PSMA) in treatment of early metastatic prostate cancer

Addition of 177Lu-PSMA-617 in the treatment of hormone sensitive metastatic prostate cancer: a prospective pilot study. - nil

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/068111

Enrollment

Registered

2024-05-30

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C61- Malignant neoplasm of prostate

Interventions

Intervention1: 177-Lutetium-PSMA: 2 cycles of 100 mCi of 177-Lutetium-PSMA will be administered at 6-8 weeks interval Control Intervention1: Not applicable. Single arm: Not applicable

Eligibility

Inclusion criteria

Inclusion criteria: Histologically proven adenocarcinoma prostate Life expectancy of greater than 9 months and ECOG zero to two Adequate organ function Hormone sensitive PSMA positive lesions in 68Ga PSMA PET/CT

Exclusion criteria

Exclusion criteria: Prior therapy with agents other than ADT Prior bone pain palliation radionuclide therapy Known hypersensitivity to study therapy Known Sjogren syndrome Concurrent serious medical conditions

Design outcomes

Primary

Measure	Time frame
Serum PSA levels after therapy Timepoint: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks and 20 weeks after therapy	—

Secondary

Measure	Time frame
FACT-P score (quality of life score)Timepoint: Baseline and 6 weeks after second cycle of Lu-PSMA	—

Countries

India

Contacts

Public ContactNandini Pandit

Jawaharlal Institue of Postgraduate Medical Education and Research

jd1111@jipmer.ac.in04132297470

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026