Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06433063
Other study ID # LuMISO
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2024
Est. completion date February 1, 2026

Study information

Verified date May 2024
Source Ankara University
Contact Cigdem Soydal, Asc Prof
Phone +903125956732
Email csoydal@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date February 1, 2026
Est. primary completion date February 1, 2026
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - over 18 years old - Patients diagnosed with prostate cancer who were referred to our clinic for Lu-177 PSMA treatment and were found suitable for treatment Exclusion Criteria: - Has a life expectancy of less than 3 months - ECOG>2 - contraindication for radionuclide treatment with Lu-177 PSMA

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
F-MISO PET
Evaluation of tumor hypoxia with F-MISO PET

Locations

Country Name City State
Turkey Ankara University Medical School Ankara

Sponsors (1)

Lead Sponsor Collaborator
Cigdem Soydal

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate tumor hypoxia with F-MISO PET to PSA response Evaluation of the effect of tumor hypoxia to PSA response after Lu-177 PSMA treatment 6. month after radionuclide treatment
Primary To evaluate tumor hypoxia with F-MISO PET to radiological response Evaluation of the effect of tumor hypoxia to radiological response with RECIST criteria after Lu-177 PSMA treatment 6. month after radionuclide treatment
Primary To evaluate tumor hypoxia with F-MISO PET to PSMA PET response Evaluation of the effect of tumor hypoxia to PSMA response with RECIP criteria after Lu-177 PSMA treatment 6. month after radionuclide treatment
See also
  Status Clinical Trial Phase
Recruiting NCT04964271 - Identification of Prostate Cancer Specific Markers in Patients Compared to Healthy Participants
Completed NCT02546908 - A Registry of Participants With Prostate Cancer in Asia
Completed NCT04838626 - Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection Phase 2/Phase 3
Recruiting NCT03101176 - Multiparametric Ultrasound Imaging in Prostate Cancer N/A
Completed NCT01683994 - Cabozantinib Plus Docetaxel and Prednisone for Advanced Prostate Cancer Phase 1/Phase 2
Completed NCT04838613 - Study of Diagnostic Performance of [18F]CTT1057 in BCR Phase 3
Completed NCT02364531 - A Canadian Observational Study in Metastatic Cancer of the Prostate: A Study of ZYTIGA Use in the Community Urology Setting
Completed NCT01929655 - Japanese BAY88-8223 Monotherapy Phase II Study Phase 2
Active, not recruiting NCT05022849 - A Study of JNJ-75229414 for Metastatic Castration-resistant Prostate Cancer Participants Phase 1
Completed NCT03261999 - Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate (LMIS 25 mg) in Subjects With Prostate Cancer Phase 3
Terminated NCT04907227 - Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921)-China Extension Phase 3
Active, not recruiting NCT03587285 - A Pilot Study of Hormonal Therapy Combined With Central Memory T Cells (Tcm) for Patients With Advanced Prostate Cancer Phase 1/Phase 2
Completed NCT02217566 - Study of Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC), Chemo-Naive, Who Received a Prior Diethylstilbestrol Therapy Phase 2
Not yet recruiting NCT04101305 - Measurement of Circulating Tumor Cells in Prostate Cancer
Active, not recruiting NCT02950064 - A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations Phase 1
Terminated NCT03066154 - Oral Docetaxel (ModraDoc/r) in Combination With Hormonal Treatment and Radiation Therapy in High-risk Prostate Cancer Phase 1
Withdrawn NCT02905201 - A Prospective Compliance Registry for Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) N/A
Completed NCT02692976 - Natural Dendritic Cells for Immunotherapy of Chemo-naive Metastatic Castration-resistant Prostate Cancer Patients Phase 2
Terminated NCT01420965 - Sipuleucel-T, CT-011, and Cyclophosphamide for Advanced Prostate Cancer Phase 2
Completed NCT01441713 - Treatment Frequency and Satisfaction in Patients With Advanced Prostate Cancer N/A