utetium PSMA versus Docetaxel in metastatic castration resistant prostate cancer

Phase 2

• Conditions: Health Condition 1: C61- Malignant neoplasm of prostate

• Registration Number: CTRI/2019/12/022282
• Lead Sponsor: Postgraduate Institute of Medical Education and Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

1.Biopsy proven adenocarcinoma prostate

2.Castration resistant prostate cancer defined by castrate serum testosterone <50 ng/dl or 1.7 nmol/l plus one of the following types of progression:

a.Biochemical progression: Three consecutive rises in PSA one week apart, resulting in two 50% increases over the nadir, and PSA >2 ng/ml.

b.Radiologic progression: The appearance of new lesions: either two or more new bone lesions on bone scan or a soft tissue lesion using the Response Evaluation Criteria in Solid Tumours.

3.Metastatic disease (as established by 68Ga â?? PSMA PET/CT)

4.Significant PSMA expression in 68Ga â?? PSMA PET/CT defined as SUVmax of lesion being significantly (1.5 x) greater than that of normal liver and/or SUVmax of >=10

5.Chemotherapy naive patients; patients with prior treatment of new generation antiandrogens will however be included

6.ECOG performance 0-2

7.Adequate renal function â?? GFR >= 40 mL/min (as estimated by 99mTc DTPA GFR)

8.Stable haematological parameters:

a.Hb >= 9 g/dL

b.Neutrophils >= 1500/mcL

c.Platelets >= 75000/mcL

9.Adequate liver function:

a.Bilirubin < 1.5 x upper limit of normal (ULN) (or if bilirubin is between 1.5-2x ULN, must have a normal conjugated bilirubin)

b.AST or ALT <= 1.5 x ULN (or <= 5.0 x ULN in the presence of liver metastases)

c.Albumin >= 2.5 g/dL

Exclusion Criteria

1. Prostate cancer with sarcomatous/spindle cell/small cell differentiation

2. PSMA expression in 68Ga â?? PSMA PET/CT, SUVmax <10 and less than liver

3. Sjogren Syndrome

4. Prior treatment with Docetaxel/Cabazitaxel/Lu PSMA

5. Active malignancy other than prostate cancer

6. Concurrent illness, including severe infection

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PSA response rate (% of patients with PSA decline â?¥50%)Timepoint: 177Lu PSMA: assessed at 6 weeks following 2nd cycle and end of treatment <br/ ><br> <br/ ><br>Docetaxel: assessed at 3 weeks following 5 cycles and end of treatment <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Progression free survival rateTimepoint: Assessed at 1 year and 2 years post first cycle;Quality of life using NCCN FACT FPSI 17 (Version 2)Timepoint: Assessed at every visit;Radiological Response (68Ga PSMA PET) <br/ ><br>Timepoint: 177Lu PSMA: assessed at 6 weeks following 2nd cycle and end of treatment <br/ ><br> <br/ ><br>Docetaxel: assessed at 3 weeks following 5 cycles and 4-6 weeks after end of treatment <br/ ><br>;Toxicity using CTCAE version 5.0Timepoint: Assessed at every visit