| 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
|
|
|
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
|
|
|
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
|
|
|
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
- 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).
- 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
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - It will be available after publication
- 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.
- 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. |