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CTRI Number  CTRI/2024/05/068111 [Registered on: 30/05/2024] Trial Registered Prospectively
Last Modified On: 26/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Radionuclide therapy]  
Study Design  Single Arm Study 
Public Title of Study   Adding injectable radioactive therapy (PSMA) in treatment of early metastatic prostate cancer 
Scientific Title of Study   Addition of 177Lu-PSMA-617 in the treatment of hormone sensitive metastatic prostate cancer: a prospective pilot study. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vignesh 
Designation  Junior Resident 
Affiliation  Jawaharlal Institue of Postgraduate Medical Education and Research 
Address  Reporting room, PET/CT building, JIPMER, Dhanvanthri nagar, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone    
Fax    
Email  Vignesh.nmed@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nandini Pandit 
Designation  Professor 
Affiliation  Jawaharlal Institue of Postgraduate Medical Education and Research 
Address  Dr. Nandini Pandit, PET/CT building, JIPMER, Dhanvanthri nagar, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  04132297470  
Fax    
Email  jd1111@jipmer.ac.in  
 
Details of Contact Person
Public Query
 
Name  Nandini Pandit 
Designation  Professor 
Affiliation  Jawaharlal Institue of Postgraduate Medical Education and Research 
Address  Dr. Nandini Pandit, PET/CT building, JIPMER, Dhanvanthri nagar, Puducherry


PONDICHERRY
605006
India 
Phone  04132297470  
Fax    
Email  jd1111@jipmer.ac.in  
 
Source of Monetary or Material Support  
JIPMER 
 
Primary Sponsor  
Name  JIPMER Institute 
Address  Dean Research, Administrative block, JIPMER, Dhanvantari Nagar, Puducherry 605006 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vignesh  JIPMER  Thyroid OPD room, PET/CT building
Pondicherry
PONDICHERRY 
04132297470

vignesh.nmed@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C61||Malignant neoplasm of prostate,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  177-Lutetium-PSMA  2 cycles of 100 mCi of 177-Lutetium-PSMA will be administered at 6-8 weeks interval 
Comparator Agent  Not applicable. Single arm  Not applicable 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  99.00 Year(s)
Gender  Male 
Details  Histologically proven adenocarcinoma prostate
Life expectancy of greater than 9 months and ECOG zero to two
Adequate organ function
Hormone sensitive
PSMA positive lesions in 68Ga PSMA PET/CT 
 
ExclusionCriteria 
Details  Prior therapy with agents other than ADT
Prior bone pain palliation radionuclide therapy
Known hypersensitivity to study therapy
Known Sjogren syndrome
Concurrent serious medical conditions 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Serum PSA levels after therapy
 
Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks and 20 weeks after therapy 
 
Secondary Outcome  
Outcome  TimePoints 
FACT-P score (quality of life score)  Baseline and 6 weeks after second cycle of Lu-PSMA 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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 2 
Date of First Enrollment (India)   07/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  It will be available after publication

  6. For how long will this data be available start date provided 09-05-2024 and end date provided 09-05-3000?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  
The current recommendations for treatment of metastatic prostate carcinoma are to combine the use of Androgen Deprivation Therapy (ADT) with other agents such as taxanes, antiandrogens (Abiraterone, Enzalutamide or Apalutamide). 177Lu-PSMA-617 is a recently emerging therapeutic radiopharmaceutical which has shown promising results in various phase 2 trials in the treatment of metastatic castration resistant prostate cancer patients - most evident in reducing the therapy related adverse effects. We expect the addition of 177Lu-PSMA-617 therapy to provide better clinical outcomes and quality of life. Once diagnosis of metastatic carcinoma prostate is established, the patients will be screened using inclusion/exclusion criteria, and will undergo a baseline salivary scintigram. Serum PSA values will be obtained pre-treatment from clinical records and serial values will be obtained 4 weekly until week 20 (that is, 12 weeks from the second cycle of 177Lu-PSMA-617). Patient’s quality of life will be assessed using FACT-P questionnaire whose responses are obtained on the day of the first cycle of 177Lu-PSMA-617 before therapy, and after 6 weeks of the last cycle of 177Lu-PSMA-617. Serum PSA values of historical control group/literature-available control group of patients with metastatic hormone sensitive prostate cancer treated with ADT plus abiraterone; will be utilized. A systematic review will be performed and outcome variables such as PSA response will be compared descriptively. If follow-up PET/CT studies with 68-Ga-PSMA are available, as part of routine clinical follow up by the treating physician, they will be commented upon.
 
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