FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/02/080273 [Registered on: 10/02/2025] Trial Registered Prospectively
Last Modified On: 10/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   To assess safety and efficacy of Relugolix Tablets in treating Advanced Prostate Cancer 
Scientific Title of Study   A Prospective, Multi-center, Single-arm, Phase IV Study to Assess the Safety and Efficacy of Relugolix Tablets for the Treatment of Advanced Prostate Cancer 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
ICR/24/003, Version 1.0, Dated 13/MAR/2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pravin Ghadge 
Designation  AVP and Head_India Clinical Research 
Affiliation  Sun Pharma Laboratories Limited 
Address  Sun house, Plot No. 201, B/1, Western Express Highway, Goregaon east. Mumbai (Suburban)

Mumbai (Suburban)
MAHARASHTRA
400063
India 
Phone  02243244324  
Fax  02243244343  
Email  pravin.ghadge@sunpharma.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Supriya Sonowal  
Designation  Medical Monitor – India Clinical Research  
Affiliation  Sun Pharma Laboratories Limited 
Address  Sun house, Plot No. 201, B/1, Western Express Highway, Goregaon east. Mumbai (Suburban)

Mumbai (Suburban)
MAHARASHTRA
400063
India 
Phone  02243244324  
Fax  02243244343  
Email  Supriya.Sonowal1@sunpharma.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajiv Yadav 
Designation  Senior Manager-India Clinical Research 
Affiliation  Sun Pharma Laboratories Limited 
Address  Sun house, Plot No. 201, B/1, Western Express Highway, Goregaon east. Mumbai (Suburban)

Mumbai (Suburban)
MAHARASHTRA
400063
India 
Phone  02243244324  
Fax  02243244343  
Email  Rajiv.Yadav1@sunpharma.com  
 
Source of Monetary or Material Support  
Sun Pharmaceutical Industries Limited (SPIL), Sun House, Plot No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400 063, Maharashtra, India. 
 
Primary Sponsor  
Name  Sun Pharmaceutical Industries Limited (SPIL) 
Address  Sun House, Plot No. 201 B/1, Western Express Highway, Goregaon(E), Mumbai 400 063, Maharashtra, India. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Sun Pharmaceutical Industries Limited  Tandalja, Vadodara -390012, Gujarat, India 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Deepak Kumar Das  All India Institute of Medical Sciences  Sijua, Patrapada, Bhubaneshwar, Odisha-751019
Khordha
ORISSA 		 9478552547

Deepak.scb2006@gmail.com 
Dr Tushar Patil Vishvasrao  Integrated Cancer Treatment & Research Center  Dept of Oncology, Ground floor, Vishwashanti Dham, Kesnand Rd, Wagholi, Pune-412207, Maharashtra.
Pune
MAHARASHTRA 		 9552522556

tussipats@hotmail.com 
Dr Minish Mahendra Jain  Noble Hospital Pvt Ltd  153, Dept of Oncology, Room No. 5, Ground floor Magarpatta City Road, Hadapsar, Pune-411013
Pune
MAHARASHTRA 		 9823133390

minishjain009@gmail.com 
Dr Kumar Prabhash  Tata Memorial Hospital  1108, 11th floor, Homi Bhabha Block Building, Dr E Borges Marg, Parel, Mumbai 400012
Mumbai
MAHARASHTRA 		 9167760576

kprabhash1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Institutional Ethics Committee I_Tata Memorial Hospital  Submittted/Under Review 
Institutional Ethics Committee, AIIMS Bhubaneshwar  Submittted/Under Review 
Noble Hospital Institutional Ethics Committee  Submittted/Under Review 
Supreme Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C61||Malignant neoplasm of prostate,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Relugolix 120 mg Tablets  Patients will receive a loading dose of 360 mg (3 tablets of Relugolix 120 mg) on day 1. From day 2, patients will take 1 tablet of Relugolix 120 mg daily till day 169 (week 24). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Male 
Details  Patient will be included if all the inclusion criteria listed below are met:
1. Male patients aged greater than or equal to 18 years who agree to provide written informed consent
2. Has histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate
3. Patient is a candidate for, in the opinion of the investigator, at least 6 months of continuous androgen deprivation therapy for the management of androgen-sensitive advanced prostate cancer
4. Has a serum testosterone at the Screening and randomization visit of greater than or equal to 150 ng/dL
5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at initial screening and at baseline
6. Is a male patient who, even if surgically sterilized, agrees to use a male condom if having sex with a woman of childbearing potential or a pregnant woman, during the entire study Treatment Period and for at least 2 weeks after last treatment dose
 
 
ExclusionCriteria 
Details  Patient will be excluded if any disease specific or study specific exclusion criteria listed below are met:
1. In the investigators opinion, is likely to require chemotherapy or surgical therapy for disease management within 6 months of initiating study drug
2. Previously received gonadotropin-releasing hormone analogue or other form of androgen deprivation therapy (estrogen or antiandrogen) for greater than 18 months total duration. If androgen deprivation therapy was received for lesser than or equal to 18 months total duration, then that therapy must have been completed at least 3 months prior to baseline. If the dosing interval of the depot is longer than 3 months, then the prior androgen deprivation therapy must have been completed at least as long as the dosing interval of the depot
3. Previous systemic cytotoxic treatment for prostate cancer
4. Patients with suspected Brain metastasis based on clinical evaluation
5. History of surgical castration
6. Have following laboratory values at screening
• Serum ALT and/or AST greater than 2 ULN
• Total bilirubin greater than ULN
• Serum creatinine greater than 2.0 mg/dL
• Platelets less than 100 x 1000 /µL
• Hemoglobin less than 10.0 g/dL
• Leukocytes (WBC) less than 3 x 1000 /µL
• Absolute neutrophil count less than 1.5 x 1000/µL
7. Previous treatment with Relugolix.
8. Known gastrointestinal disease or procedure that could interfere with the oral absorption or tolerance of relugolix, including inability to swallow whole tablets
9. Any other medical or psychiatric condition or laboratory examination finding that, in the opinion of the investigator, would interfere with accomplishing the study objectives or the patient completing the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Sustained castration rate defined as proportion of patients achieving and maintaining serum testosterone at castrate level (lesser than 50ng/dL) by week 4 through 24 weeks of treatment  Day 29 to Day 169 
 
Secondary Outcome  
Outcome  TimePoints 
1. Castration rate defined as proportion of patients achieving serum testosterone lesser than 50ng/dL.   Day 4, Day 8 (week 1) and Day 15 (week 2) 
2. Profound castration rate defined as proportion of patients achieving serum testosterone lesser than 20ng/dL  Day 15 (week 2) 
3. Sustained Profound castration rate defined as proportion of patients achieving and maintaining serum testosterone suppression of lesser than 20 ng/dL by Week 4 through 24 weeks of treatment   [Day 29 to Day 169].  
4. PSA response rate   Day 15 (week 2), Day 29 (week 4), Day 57 (week 8), Day 85 (week 12), Day 113 (week 16), Day 141 (week 20), Day 169 (week 24) 
 
Target Sample Size   Total Sample Size="127"
Sample Size from India="127" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   21/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  21/02/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This is a Phase IV, single arm, multicenter, open label, study in patients with advanced prostate cancer. The study will be initiated only after the receipt of regulatory and ethics committee (EC) approval.

After confirming the eligibility patients will be enrolled in the study. The enrolled patients will undergo 24 weeks treatment period. Patients will receive a loading dose of 360 mg (3 tablets of Relugolix 120 mg) on day 1. From day 2, patients will take 1 tablet of Relugolix 120 mg daily till day 169  for 24 weeks (Treatment period). And week 24 will be considered EOT visit. During the study, assessments will be performed as mentioned in Schedule of Assessment.

The study consists of total twelve visits. Both efficacy and safety will be assessed during the study period. Patients who are withdrawn/ terminating early from the study will complete end of treatment visit assessment and will be followed up for safety 2 weeks after last IP dose. Patients will be provided with diary to record details about study drug administration and adverse events. Patients will be required to bring completed diary of previous visit at upcoming visit to facility.

 
Close