Determining the efficacy and safety of Lutetim-177-PSMA-617 therapy in paitents with metastatic prostate cancer after radical prostatectomyand bilateral orchitectomy
Design
Clinical trial without control group, phase 2, on patients with metastatic prostate cancer after radical prostatectomyand bilateral orchitectomy
Settings and conduct
Patients with metastatic prostate cancer after radical prostatectomyand bilateral orchitectomy who met the eligibility criteria are recommended to receive Lutetim therapy. After obtaining the written inform consent, and a complete clinical history a fasting serum sample will be taken to perform hematological and biochemical tests and an ultrasound of the urinary tract will be performed. And DTPA SCAN is done. patients receive two course of Lutetium therapy, they are evaluated every 4 weeks in terms of treatment complications, liver function parameters and cell counts. They are followed up by blood. PSA is measured every month and a whole body scan is performed 24 hours after injection. Response to treatment will be assessed after 2 and 4 months of lutetium therapy in terms of PSA, AlP serum levels, improvement of clinical symptoms (such as bone pain), and reduction of bone and lymph metastatic areas using 68Ga- PSMA PET/CT scan .
Participants/Inclusion and exclusion criteria
1-Men with metastatic prostate cancer after radical prostatectomyand bilateral orchitectomy
2- 68Ga-PSMA-PET/CT positive scan
Exclusion criteria:
1- Creatinine >=2mg/dl
2-Obstructive DTPA SCAN
3-GFR≤30
4-WBC≤2000l
5-PLAT≤75000
6-ECOG>2
7- Patients with life expectancy<12 weeks
Intervention groups
Patients with metastatic prostate cancer who Lutetim-177-PSMA-617 as a treatment(2 courses with 2 months interval).Not have control group.
Main outcome variables
PSA; ALT; AST; ALKP; LDH; WBC; Hb; Plt; Creatinin; BUN; GFR; ECOG; bone and lymph metastatic areas; Gleason score
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20230414057906N1
Registration date:2023-04-23, 1402/02/03
Registration timing:prospective
Last update:2023-04-23, 1402/02/03
Update count:0
Registration date
2023-04-23, 1402/02/03
Registrant information
Name
Saber Amanollahi Soudmand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2207 3035
Email address
saberas_2008@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-05, 1402/02/15
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and safetyof Lutetim-177-PSMA-617 therapy in paitents with metastatic prostate cancer after radical prostatectomyand bilateral orchitectomy
Public title
Efficacy and safety of Lutetim-177-PSMA-617 therapy in paitents with metastatic prostate cancer after radical prostatectomyand bilateral orchitectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men with metastatic prostate cancer after radical prostatectomy and bilateral orchitectomy
68Ga-PSMA-PET/CT positive scan
Having willingness to participate in this study
Exclusion criteria:
Creatinine >=2 mg/dl
Obstructive DTPA SCAN
GFR≤30
WBC≤2000
Hb≤8g/dl
Previous history of chemotherapy/radiotherapy for prostate cancer
PLAT≤75000
ALT/AST >5 times of upper normal limit for those with liver metastasis or <2 times for those without liver metastasis.
Patients with life expectancy <12 weeks
Age
From 20 years old to 85 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
12
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Pilot study
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research Faculty of Medicine, Shahid Beheshti University of Medical Sciences
At first, PSMA-617 is labeled with LU-177 chloride. LU-PSMA is infused at the rate of -7.4GBq within 30-60 seconds along with one liter of normal saline serum. All the standard measures of lutetium therapy include placing an ice pack on the salivary glands from 30 minutes before to 4 hours after and consuming plenty of fluids before and after the treatment. The patient is monitored 4 hours after the injection and then discharged.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Labbafinezhad Hospital
Full name of responsible person
Saber Amanollahi Soudmand
Street address
Labbafinezhad Hospital, 9th Bostan, Pasdaran Street
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 23601
Email
saberas_2008@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Kodakyar Allay, Daneshjoo Bolvard, Velenjak Street
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
site@sbmus.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saber Amanollahi Soudmand
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Labbafinezhad Hospital,9th Boostan St, Pasdaran
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 23871
Email
saberas_2008@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saber Amanollahi Soudmand
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Labbafinezhad Hospital, 9th Boostan St., Pasdaran
City
Tehran
Province
Tehran
Postal code
1166666311
Phone
+98 21 2207 3035
Email
saberas_2008@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
saber amanollahi soudmand
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Labbafinezhad Hospital, 9th Boostan St., Pasdaran
City
tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 23601
Email
saberas_2008@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Using data for running a mata-analysis
From where data/document is obtainable
Principle investigator
What processes are involved for a request to access data/document
Submission and approval in the research committee(on average 2 months)