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.
- Conditions
- Health Condition 1: C61- Malignant neoplasm of prostate
- Registration Number
- CTRI/2020/10/028341
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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 < 50 ml/min.
7.Compromised bone marrow function-
Hemoglobin level < 9 g/dl
Platelets < 1,00,000 per cubic milliliter
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method