Evaluation of efficacy and complication of peptide receptor radionuclide therapy( PRRT) with Lu177-PSMA in patients with Castration-resistant prostate cancer(CRPC)
Design
20 patients with prostate cancer (pathological report) and refractory to routine treatment (CRPC) referred by an oncologist and imaged by Ga68-PSMA PET/CT if they had uptake in metastases, they enrolled in the study
Settings and conduct
If metastases showed uptake in PSMA -PET/CT scan then the patients admitted by nuclear medicine department in ghaem hospital of Mashad University of medical sciences for slow infusion of Lu177-PSMA
Participants/Inclusion and exclusion criteria
Castration-resistant prostate cancer patients with metastases and refractory to routine treatment.
Exclusion criteria: Renal failure and life expectancy less than 4 months
Intervention groups
Efficacy of treatment and complication of Lu-PSMA in CRPC patients
Main outcome variables
PSA level. free progression survival, pain relief change, quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180113038331N1
Registration date:2018-03-14, 1396/12/23
Registration timing:registered_while_recruiting
Last update:2018-03-14, 1396/12/23
Update count:0
Registration date
2018-03-14, 1396/12/23
Registrant information
Name
Kamran Aryana
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3881 3554
Email address
aryanak@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-13, 1396/09/22
Expected recruitment end date
2018-12-13, 1397/09/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Treatment of castration-resistant metastatic prostate cancer, refractory to routine treatment with Lu177-PSMA
Public title
Treatment of patients with castration-resistant metastatic prostate cancer with nuclear medicine procedure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Hx of metastatic prostate cancer resistant to usual treatment
Positive Ga68-PSMA PET/CT scan
ESOG 0-2
Exclusion criteria:
survival less than 4 months
GFR less than 40cc/min
ُSerum creatinin >1.5
Urinary tract obstruction
Bone marrow suppression (WBC <2500 Plat<80000 Hct<8
Age
No age limit
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
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
Ethics commitee of Mashhad University of Medical Sciences
Street address
Daneshgah St
City
Mashhad
Province
Razavi Khorasan
Postal code
91839
Approval date
2017-07-05, 1396/04/14
Ethics committee reference number
IR.MUMS.fm.REC.1396.414
Health conditions studied
1
Description of health condition studied
Castration resistant metastatic prostate cancer
ICD-10 code
C61
ICD-10 code description
Malignant neoplasm of prostate
Primary outcomes
1
Description
1-Change the number of metastases
Timepoint
After three cycle of therapy
Method of measurement
1-Comparison with result of first functional and anatomical imaging
Secondary outcomes
1
Description
Intensity of pain
Timepoint
Before treatment and then every week until to the end of treatment
Method of measurement
Standard check list
2
Description
Quality of life
Timepoint
Every 15 days
Method of measurement
Karnofsky score
Intervention groups
1
Description
Intervention group: Castration resistant metastatic prostate cancer . Administration of Lu-PSMA 150-200 mCI every 2 months for 3 to 5 courses
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Kamran Aryana
Street address
Ahmadabad
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3881 3554
Email
Aryanak@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Kamran Aryana
Street address
Ahmadabad st -Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
91839
Phone
+98 51 3881 3554
Email
Aryanak@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Pars Isotope company
Proportion provided by this source
90
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Kamran Aryana
Position
Assistant professor of nuclear medeicine
Latest degree
Specialist
Other areas of specialty/work
Nuclear Medicine
Street address
Ahmadabad
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3881 3554
Email
aryanak@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Kamran Aryana
Position
Assistant professor of nuclear medicine
Latest degree
Specialist
Other areas of specialty/work
Nuclear Medicine
Street address
Ahmadabad
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3881 3554
Email
Aryanak@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Kamran Aryana
Position
Assistant professor of nuclear medicine
Latest degree
Specialist
Other areas of specialty/work
Nuclear Medicine
Street address
Ahmadabad
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3881 3554
Email
Aryanak@mums.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
A part of information
When the data will become available and for how long
َAfter publication
To whom data/document is available
ALL resercher
Under which criteria data/document could be used
No restriction
From where data/document is obtainable
Kamran Aryana
Aryanak@mums.ac.ir
What processes are involved for a request to access data/document