The efficiency of endoradiotherapy with 225Ac-PSMA in metastatic castration-resistant prostate cancer patients (mCRPC)
Design
This is an interventional clinical trial with a single group design of 10 patients, performing between November 2021 and November 2022 that will be followed between treatment sessions.
Settings and conduct
Patients are selected and justified in the nuclear medicine center of the Persian Gulf hospital at Bushehr. The consent form is obtained and finally, the treatment will be performed with intravenous injection of 225-Ac-PSMA-617. After injection, patients will be undergone a whole-body scan for the assessment of radiotracer distribution. Six to eight weeks after the 225-Ac-PSMA-617 therapy, the patients will be visited by oncologists and nuclear medicine physicians and if there was not any toxicity, the next treatment session will be performed.
Participants/Inclusion and exclusion criteria
Patients must have had progressive metastatic castration-resistant prostate cancer, positive 68Ga-PSMA-11 PET/CT scan, recovered or stabilized to ≤ Grade 2 from all clinically significant toxicities related to prior prostate cancer therapy, and an ECOG performance status of 0 to 2.
Exclusion criteria: Previous treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or Hemi-body irradiation or previous PSMA-targeted radioligand therapy, patients diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment.
Intervention groups
We are going to use a single group of patients to evaluate the efficiency of 225-Ac-PSMA-617 in the treatment of prostate cancer.
Main outcome variables
The proportion of patients who have a partial, stable (not-progressed), or complete response to therapy.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210612051548N1
Registration date:2021-09-22, 1400/06/31
Registration timing:prospective
Last update:2021-09-22, 1400/06/31
Update count:0
Registration date
2021-09-22, 1400/06/31
Registrant information
Name
Majid Assadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3332 0361
Email address
assadipoya@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Targeted α-Therapy in Metastatic Castration Resistant Prostate Cancer with 225Ac-PSMA-617
Public title
Targeted α-Therapy in Prostate Cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients must have had progressive metastatic castration-resistant prostate cancer.
Patients must have a positive 68Ga-PSMA-11 PET/CT scan.
Patients must have recovered or stabilized to ≤ Grade 2 from all clinically significant toxicities related to prior prostate cancer therapy.
Patients must have an ECOG performance status of 0 to 2.
Exclusion criteria:
Previous treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or hemi-body irradiation or previous PSMA-targeted radioligand therapy.
The patient was diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment (Patients with a prior history of malignancy who have been disease-free for more than 3 years are eligible).
Age
From 18 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committee of Bushehr university of medical sciences
Street address
Bushehr University of Medical Sciences, Bushehr,Iran
City
Bushehr
Province
Boushehr
Postal code
45654775
Approval date
2021-06-27, 1400/04/06
Ethics committee reference number
IR.BPUMS.REC.1400.057
Health conditions studied
1
Description of health condition studied
Prostate cancer
ICD-10 code
C61
ICD-10 code description
Malignant neoplasm of prostate
Primary outcomes
1
Description
Numbe of treated prostate cancer patients
Timepoint
4-6 weeks after last treatment session
Method of measurement
Image-based response using 68Ga-PSMA PET/CT
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, the 225Ac-PSMA-617 radiopharmaceutical is injected intravenously into 10 patients with prostate cancers according to the 68Ga-PSMA-11 PET/CT. Then whole-body scan is performed at 24 hours, and 48 hours after injection to assess radiotracer distribution. Six to eight weeks after the 225-Ac-PSMA-617 therapy, the patients will be visited by oncologists and nuclear medicine physicians and if there was not any toxicity, the next treatment session will be performed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Nuclear Medicine Center, Persian Gulf Hospital
Full name of responsible person
Majid Assadi
Street address
Persian Gulf Hospital,Taleghani Street,Bushehr,Iran
City
Bushehr
Province
Boushehr
Postal code
45654775
Phone
+98 77 3332 0361
Email
assadipoya@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Gholamreza Khamisipour
Street address
Vice-Chancellor for Research and Technology of Bushehr University of Medical Sciences, Salman-e-Farsi Blvd,Bushehr,Iran.
City
Bushehr
Province
Boushehr
Postal code
45654775
Phone
+98 77 3345 0178
Fax
Email
khamisipourgholamreza@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Bushehr 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
Boushehr University of Medical Sciences
Full name of responsible person
Majid Assadi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Nuclear Medicine
Street address
The Persian Gulf Nuclear Medicine Research Center, Bushehr University of Medical Sciences,Moallem Street, Bushehr, Iran
City
Bushehr
Province
Boushehr
Postal code
45654775
Phone
+98 77 3332 0361
Fax
+98 77 3332 0361
Email
assadipoya@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Majid Assadi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Nuclear Medicine
Street address
The Persian Gulf Nuclear Medicine Research Center, Bushehr University of Medical Sciences,Moallem Street, Bushehr, Iran
City
Bushehr
Province
Boushehr
Postal code
45654775
Phone
+98 77 3332 0361
Fax
+98 77 3332 0361
Email
assadipoya@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Narges Jokar
Position
Research Instructor
Latest degree
Master
Other areas of specialty/work
Medical Physics
Street address
The Persian Gulf Nuclear Medicine Research Center, Bushehr University of Medical Sciences,Moallem Street, Bushehr, Iran
City
Bushehr
Province
Boushehr
Postal code
45654775
Phone
+98 77 3332 0361
Fax
+98 77 3332 0361
Email
narges.jokar69@gmail.com
Web page address
https://pgnmrc.bpums.ac.ir/fa/index.aspx
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
There is no further information
When the data will become available and for how long
There is no further information
To whom data/document is available
There is no further information
Under which criteria data/document could be used
There is no further information
From where data/document is obtainable
There is no further information
What processes are involved for a request to access data/document