Comparison of two different radionuclide therapies for the treatment of metastatic castration resistant prostate cancer

Comparison of targeted 225Ac-PSMA-617 alpha particle therapy versus 177Lu-PSMA-617 beta particle therapy in metastatic castration resistant prostate cancer patients: An open-label, two-arm, phase II RCT

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/09/021233

Enrollment

Registered

2019-09-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: N429- Disorder of prostate, unspecified

Interventions

Intervention1: 225Ac-PSMA-617: 225Ac-PSMA-617 is a targeted alpha particle radioligand therapy in the treatment of end-stage prostate cancer route of administration: intravenous slow infusion Dosage:

Eligibility

Inclusion criteria

Inclusion criteria: Patients with histologically or cytologically confirmed adenocarcinoma of prostate. Patients with disease progression in spite of androgen deprivation therapy or chemotherapy. Surgically or medically castrated 68Ga-PSMA PET/CT showing sites of PSMA expressing disease Patients ECOG performance status Patients Karnofsky performance status of >= 60 Patients with GFR level >= 60 ml/min Normal KFT( Kidney Function Test) and LFT (Liver Function Test)• At least four weeks gap between prior surgery or radiotherapy

Exclusion criteria

Exclusion criteria: Negative 68Ga-PSMA PET/CT scan or bone scan History of pituitary or adrenal dysfunction Anticipated life expectancy of less than 6 months Patients with history of prior cardiac disease Abnormal amino transferase levels; More than 2.5 times the upper value of the normal rangesin patients without liver metastases • Less than 5 times the upper value of the normal range in patients with known liver metastasis Active or symptomatic viral hepatitis or chronic liver disease patients History of a different malignancy except for the following circumstances: diseasefree survival for at least 5 years and deemed by the investigator to b at low-risk for recurrence of that malignancy. Patients not giving written informed consent

Design outcomes

Primary

Measure	Time frame
1. sPSA response according to Prostate Cancer Working Group 3 criteria (PCWG3). 2. Progression-free survival (PFS)Timepoint: 36 months	—

Secondary

Measure	Time frame
Overall survival (OS), Toxicity, Quality of life (QOL)Timepoint: 36 months	—

Countries

India

Contacts

Public ContactDr Chandrasekhar Bal

All India Institute of Medical Sciences

csbal@hotmail.com9013775659

Outcome results

None listed

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