Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06433063
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-06
Brief Title:
Effect of Hypoxia on FMISO PET to Response to Lu-177 PSMA Treatment
Sponsor:
Cigdem Soydal
Organization:
Ankara University
Study Overview
Official Title:
Effect of 18F-Fluoromisonidazole 18F-FMISO PET Imaging on Evaluation of Hypoxia Before Lu-177 PSMA Treatment for Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LuMISO
Brief Summary:
It is aimed to evaluate hypoxia before Lu-177 PSMA treatment in prostate cancer and to show its effect on treatment success with 18F-FMISO PET imaging which allows in-vivo evaluation and quantification of tumor hypoxia which is known to be one of the factors affecting radiotherapy resistance
Detailed Description:
Prostate cancer is the second most common cancer in men and the fifth leading cause of cancer-related deaths 20 of patients diagnosed with prostate cancer have metastatic disease and survival rates of more than 5 years have been reported in only 26-30 of them Androgen deprivation therapy ADT is the main treatment method used for years in the treatment of prostate cancer However a high rate of resistance develops to this treatment and becomes castration-resistant prostate cancer Castration-resistant prostate cancer CRPC is defined as an increase in PSA levels clinical or radiological progression or the emergence of new distant metastases despite lowering serum testosterone to castration levels FDA-approved drugs such as Sipuleucel-T Docetaxel Cabazitaxel Abireterone Enzalutamide Radium-223 Rucaparib and Olaparib have been shown to increase overall survival in mKDPK Although there are many treatment classes that delay disease progression and increase survival mKDPK remains incurable and fatal Radionuclide therapy Lu-177 PSMA has emerged as a promising treatment in patients resistant to these treatments Although some criteria have been defined to select patients who will benefit from treatment based on parameters such as SUVmax some of the patients do not respond to radionuclide treatments and PSA response can be achieved in only a little more than half of the patients in Lu-177 PSMA treatment which stands out as one of the most effective therapies The role of hypoxia which is one of the possible factors affecting the treatment response other than PSMA avidity in the success of Lu-177 PSMA treatment is currently unclear
Radiation damage causing cell apoptosis and necrosis occurs through mechanisms such as ionizing radiation causing single or double chain breaks and creating reactive oxygen compounds in surrounding molecules It is known that hypoxia causes radiotherapy resistance by preventing the formation of reactive oxygen compounds in tumors
18F-Fluoromisonidazole 18F-FMISO is an 18F-labelled PET radiopharmaceutical like 18F-FDG which has a half-life of 110 minutes and is frequently used in clinical practice 18F-FMISO is a nitroimidazole class compound known to accumulate in hypoxic cells After entering viable cells 18F-FMISO is reduced to the RNO2 radical In the presence of oxygen 18F-FMISO can be oxidized again and freely exit the cell However since re-oxidation is not possible in hypoxic cells 18F-FMISO is trapped in hypoxic but viable cells
It has previously been shown that it is possible to predict radiotherapy response with 18F-FMISO PET imaging in malignancies such as head-neck and lung cancers and the feasibility of personalized treatment according to hypoxia demonstrated with 18F-FMISO In a study the presence of hypoxia was demonstrated with 18F-FMISO PET in high-grade tumors in patients receiving neoadjuvant ADT and hypoxia was shown to regress with tumor response However to our knowledge there is no study yet for Lu-177 PSMA treatment which is one of the most important internal radiotherapies in prostate cancer In this study it was aimed to quantify hypoxia in primary tumors and metastases of prostate cancer with 18F-FMISO and to show its effect on treatment resistance
Patients referred for Lu-177 PSMA treatment and found suitable for treatment will be included in the study Within 4 weeks before Lu-177 PSMA treatment patients will undergo PET imaging after 18F-FMISO injection and SUVmax SUVmean metabolic tumor volume and total 18F-FMISO retention parameters will be obtained from the tumors Following this patients will receive Lu-177 PSMA treatment in 4 cycles at 6-8 week intervals as applied in standard clinical practice Treatment response will be evaluated with Ga68 PSMA PET images taken after 4 cures of Lu-177 PSMA treatment With 18F-FMISO findings no changes will be made in the treatment process of the patients and no additional imaging or examination will be performed after the treatment other than routine clinical practice
Radiation damage causing cell apoptosis and necrosis occurs through mechanisms such as ionizing radiation causing single or double chain breaks and creating reactive oxygen compounds in surrounding molecules It is known that hypoxia causes radiotherapy resistance by preventing the formation of reactive oxygen compounds in tumors
18F-Fluoromisonidazole 18F-FMISO is an 18F-labelled PET radiopharmaceutical like 18F-FDG which has a half-life of 110 minutes and is frequently used in clinical practice 18F-FMISO is a nitroimidazole class compound known to accumulate in hypoxic cells After entering viable cells 18F-FMISO is reduced to the RNO2 radical In the presence of oxygen 18F-FMISO can be oxidized again and freely exit the cell However since re-oxidation is not possible in hypoxic cells 18F-FMISO is trapped in hypoxic but viable cells
It has previously been shown that it is possible to predict radiotherapy response with 18F-FMISO PET imaging in malignancies such as head-neck and lung cancers and the feasibility of personalized treatment according to hypoxia demonstrated with 18F-FMISO In a study the presence of hypoxia was demonstrated with 18F-FMISO PET in high-grade tumors in patients receiving neoadjuvant ADT and hypoxia was shown to regress with tumor response However to our knowledge there is no study yet for Lu-177 PSMA treatment which is one of the most important internal radiotherapies in prostate cancer In this study it was aimed to quantify hypoxia in primary tumors and metastases of prostate cancer with 18F-FMISO and to show its effect on treatment resistance
Patients referred for Lu-177 PSMA treatment and found suitable for treatment will be included in the study Within 4 weeks before Lu-177 PSMA treatment patients will undergo PET imaging after 18F-FMISO injection and SUVmax SUVmean metabolic tumor volume and total 18F-FMISO retention parameters will be obtained from the tumors Following this patients will receive Lu-177 PSMA treatment in 4 cycles at 6-8 week intervals as applied in standard clinical practice Treatment response will be evaluated with Ga68 PSMA PET images taken after 4 cures of Lu-177 PSMA treatment With 18F-FMISO findings no changes will be made in the treatment process of the patients and no additional imaging or examination will be performed after the treatment other than routine clinical practice
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None