utetium PSMA versus docetaxel in metastatic prostate cancer

Phase 2

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

• Registration Number: CTRI/2022/03/041265
• Lead Sponsor: All India Institute of Medical Sciences New Delhi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Histologically proven adenocarcinoma prostate

High-volume metastatic disease (as established by 68Ga-PSMA-11 PET/CT) defined as presence of visceral metastasis or >=4 bone lesions with at least one extra-axial lesion

Significant PSMA expression in 68Ga-PSMA-11 PET/CT defined as avidity of lesion being greater than that of normal liver

ECOG performance 0-2

Adequate renal function â?? eGFR >= 30 mL/min

Stable haematological parameters:

oHb >= 8 g/dL

oNeutrophils >= 1500/mcL

oPlatelets >= 75000/mcL

Adequate liver function:

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

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

oAlbumin >= 2.5 g/dL

Prior treatments allowed:

oFor de-novo mHSPC: prior ADT allowed if commenced within 90 days of randomization and no evidence of progressive disease; prior palliative radiotherapy or surgery allowed if conducted >=4 weeks prior to randomization

oFor localized PCa progressing to mHSPC (all treatments completed >=6 months prior to randomization)

ï?§<=36 months of ADT

ï?§All other forms of prior therapies including radiation therapy, prostatectomy and lymph node dissection

Exclusion Criteria

Prostate cancer with sarcomatous/spindle cell/small cell differentiation

PSMA expression in 68Ga-PSMA-11 PET/CT less than liver

Sjogren Syndrome

Active malignancy other than prostate cancer

Concurrent illness, including severe infection

Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception

Prior treatment with docetaxel or novel anti-androgens

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PSA complete response rate at 6 months <br/ ><br> <br/ ><br>Castration-resistance free survival rate at 2 yearsTimepoint: PSA follow-up every 3 weeks till 24 weeks, then every 4 weeks till 12 months, followed by every 12 weeks till 5 years <br/ ><br> <br/ ><br>Radiological follow-up every 3 months till 2 years after enrolment of last patient, then every 6 months till 5 years