To Investigate the anti-proliferative and anti-cancer potential of Moclobemide (an anti-depression drug) in castration resistant prostate cancer.

Phase 2

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

• Registration Number: CTRI/2023/01/048893
• Lead Sponsor: ICMR-Product Development Centre at AIIMS New Delhi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

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

Inclusion Criteria

1.Age>=18 years

2.Castration-resistant prostate cancer patients (CRPC): Disease progression despite androgen-deprivation therapy (ADT) and may present as one or any combination of a continuous rise in serum levels of prostate-specific antigen (PSA), progression of pre-existing disease, or appearance of new metastases (Ga-68-PSMA PET/CT Scan) and characterized by low levels of testosterone ( <50 ng/dl).

Exclusion Criteria

1.Patients who are not willing to participate

2.Active psychiatric illnesses that would limit compliance with protocol requirements

3.Patients taking tricyclic/tetracyclic antidepressants or selective serotonin reuptake inhibitors, or serotonin norepinephrine reuptake inhibitors or conventional monoamine oxidase inhibitors or thioridazine or dextromethorphan or bupropion or triptans or tramadol or meperidine or selegiline or any antipsychotic drugs or sympathomimetic drugs or linezolid

4.Patients with connective tissue disorders like systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis and other autoimmune disorders

5.Patients with hepatic dysfunction that is those in whom serum bilirubin will be more than 1.5 and, AST and ALT will be more than 2.5 fold higher than the upper limit of normal

6.Patients in whom serum creatinine will be more than 1.5 fold higher than the upper limit of normal

7.Patients with congestive cardiac failure, severe or unstable angina or thyrotoxicosis

8.Atrial Fibrillation, or other cardiac arrhythmia requiring medical therapy

9.Administration of any other investigational therapeutic agent within 30 days of screening

10.Prior radiation therapy completed < 4 weeks prior to enrolment

11.Any currently active second malignancy

12.Patients in whom urgent chemotherapy, in the opinion of the treating physician, is indicated

13.Patients taking strong CYP2D6, CYP2C19 and CYP3A4 inducer or inhibitor, available from Metabolism and Transport Drug Interaction Database (http://www.druginteractioninfo.org)

14.Pheochromocytoma

15.Carcinoid Syndrome

16.Angle-closure glaucoma

Study & Design

• Study Type: Interventional
• Study Design: Not specified