utetium PSMA plus rucaparib in advanced prostate cancer

Phase 2

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

• Registration Number: CTRI/2022/02/040221
• 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: 17 October 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Age �18 years with written informed consent

Histologically-proven adenocarcinoma prostate

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: Biochemical progression or Radiologic progression

Metastatic disease (as established by 68Ga-PSMA-11 PET/CT)

Significant PSMA expression in 68Ga-PSMA-11 PET/CT defined as tracer avidity of at least 80% of the lesions being significantly (1.5x) greater than that of normal liver with none of the lesions having uptake less than that of liver

Disease progression following at least one line of taxane-based chemotherapy or one of the novel androgen-axis drugs (abiraterone/ enzalutamide)

At least 4 weeks following the completion of any surgery or radiotherapy prior to recruitment

ECOG performance 0-2

Life expectancy � 12 weeks

Adequate renal function ââ?¬â?? eGFR ââ?°Â¥ 30 mL/min

Stable haematological parameters:

Hb � 9 g/dL

Neutrophils � 1500/mcL

Platelets � 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

Exclusion Criteria

Prostate cancer with sarcomatous/spindle cell/small cell differentiation

Sjogren Syndrome

Prior treatment with 177Lu-PSMA-RLT/ 225Ac-PSMA-RLT/ PARP inhibitors/ platinum-based chemotherapy/ mitoxantrone/ cyclophosphamide

Patients with symptomatic or impending spinal cord compression unless treated prior to recruitment and clinically stable for �4 weeks

Active malignancy other than prostate cancer

Concurrent illness, including severe infection

Patients unable to swallow oral medications or with malabsorption disorders

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

Known hypersensitivity to rucaparib

Study & Design

• Study Type: Interventional
• Study Design: Not specified