A study to evaluate new treatment for prostate cancer with a type of radiation therapy with radionuclide - Lu psma and to compare with the standard treatment with Abiratetone.

Radionuclide therapy with 177Lu-PSMA plus Abiraterone (with ADT) versus Abiraterone (with ADT) alone in metastatic, hormone-sensitive prostate cancer: a randomized phase 2 trial - REPLASE

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/10/028341

Enrollment

Registered

2020-10-12

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: C61- Malignant neoplasm of prostate

Interventions

Intervention1: Lu-PSMA : Lu-PSMA will be administered by slow intravenous infusion, in 100ml of saline. A SPECT-CT of the whole body will be done after 24 hours of the Lu-PSMA infusion. Medicati

Eligibility

Inclusion criteria

Inclusion criteria: 1. Biopsy proven adenocarcinoma of the prostate 2. Metastatic disease (poly metastatic â??more than 3 metastatic lesions) evident on imaging (CT and/or bone scan/Ga PSMA). 3. Patients who are planned for treatment with Abiraterone. 3. PSMA-avid disease on Ga PSMA scan (uptake equal or more than the liver) 5. ECOG performance status 0-2 5. Participant is willing to comply with all study treatments, procedures, and assessments 6. Signed, written, informed consent.

Exclusion criteria

Exclusion criteria: 1. ADT started more than 13 weeks prior to randomisation 2. Rising PSA after starting ADT for metastatic disease. 3. Sjogrens disease are other contraindications to Lu-PSMA. 4. Oligometastatic disease â?? who have less than 3 or 3 metastatic lesions. 5. Other active malignancy within the last 3 years that has not been treated adequately with curative intent. 6. Poor renal function â?? serum creatinine > 1.6mg/dl or a creatinine clearance of 7. Compromised bone marrow function- Hemoglobin level Platelets WBC count less than 2000 millilitre. 8. Compromised liver function â?? Total bilirubin level more than 1.5 times the normal 9. Estimated life expectancy less than 6 months.

Design outcomes

Primary

Measure	Time frame
The main objective of the study is to compare the proportions of men in each treatment group whose serum PSA is 0.2 ng/ml 24 weeks after randomizationTimepoint: The main objective of the study is to compare the proportions of men in each treatment group whose serum PSA is 0.2 ng/ml 24 weeks after randomization	—

Secondary

Measure	Time frame
Percentage reductions in serum PSA from baseline to week 24 2. Proportions of men with a PSA reduction from baseline to 50% or more (PSA response rate) 3. Proportions of men with an objective tumour response (RECIST 1.1) 4. PSA-progression-free survival (PSA-PFS, randomization to PSA 25% above nadir) 5. Frequency and severity of adverse events (CTCAE v5.0) 6. Effects on aspects of health-related quality of life (HRQL, measured with EORTC QLQ-C30) 7. Overall survival Timepoint: 24 weeks	—

Measure

Time frame

Percentage reductions in serum PSA from baseline to week 24 2. Proportions of men with a PSA reduction from baseline to 50% or more (PSA response rate) 3. Proportions of men with an objective tumour response (RECIST 1.1) 4. PSA-progression-free survival (PSA-PFS, randomization to PSA 25% above nadir) 5. Frequency and severity of adverse events (CTCAE v5.0) 6. Effects on aspects of health-related quality of life (HRQL, measured with EORTC QLQ-C30) 7. Overall survival Timepoint: 24 weeks

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Countries

India

Contacts

Public ContactArchi Agrawal

Tata Memorial Hospital

drarchi23@gmail.com02224177016

Outcome results

None listed

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