[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"St Vincent's Hospital, Sydney\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":185},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,48,75,102,130,154],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100635456","determining-individual-preferences-for-gynecomastia-avoidance-dingo---stage-1-100635456",false,"NCT07552922","Determining INdividual Preferences for Gynecomastia avOidance (DINGO) - Stage 1","Determining INdividual Preferences for Gynecomastia avOidance (DINGO) - Qualitative Stage","DINGO","Inclusion Criteria:\n\n* Men with high-risk BCR PCa but no ADT+\u002F-ARPI experience.\n* Men with ADT+\u002F-ARPI experience who have experienced breast-related side effects from this treatment.\n\nExclusion Criteria:\n\n• Men receiving psychiatric care as a consequence of their prostate cancer diagnosis or treatment thereof.","MALE","18 Years",{"count":20,"type":21},24,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study aims to explore the perceptions of men with prostate cancer (PCa) and high-risk biochemical recurrence (BCR) regarding the risk of breast-related side effects, including gynaecomastia, from treatment.",[27],"Prostate Cancer (Adenocarcinoma)",[29,30,31,32,33,34],"gynaecomastia","prostate cancer","LHRH","testosterone","breast","estrogen","RECRUITING","2026-04-22",{"date":38,"type":39},"2026-04-27","ACTUAL",{"date":41,"type":39},"2025-12-01",{"date":43,"type":21},"2026-11-30",{"name":45,"class":46},"St Vincent's Hospital, Sydney","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":56,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100608579","phase-1-tebentafusp-and-roginolisib-in-uveal-melanoma-to-prolong-t-cell-homeostasis-100608579","NCT07203391","Tebentafusp and Roginolisib in Uveal Melanoma to Prolong T-cell Homeostasis","TRIUMPH - Tebentafusp and Roginolisib in Uveal Melanoma to Prolong T-cell Homeostasis","TRIUMPH","Inclusion Criteria:\n\n1. Male or female participants must be aged 18 years or over at the time, to be eligible to participate in this study.\n2. Histologically or cytologically confirmed metastatic UM or unresectable UM patients\n3. HLA-A\\*02:01 positive\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n5. Currently undergoing first-line treatment for mUM with tebentafusp\n6. Tebentafusp related toxicity, including cytokine release syndrome that has resolved to grade ≤ 1 as per CTCAE v5.0.\n7. Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control (eg double barrier) from the trial screening date until 6 months after the final dose of the program intervention; cessation of birth control after this point shall be discussed with a responsible physician.\n8. Pregnant or lactating women are prohibited from enrolling on this program.\n9. Male participants are not allowed to donate sperm from the time of enrolment until 6 months post- administration of program interventions.\n\nExclusion Criteria:\n\n1. Presence of untreated or symptomatic central nervous system (CNS) metastases, leptomeningeal disease, or cord compression. NOTE: Participants with treated CNS lesions may enroll provided all of the following apply:\n\n   1. Treated CNS lesions must be radiographically stable for ≥ 4 weeks after intervention (surgery and\u002For radiation).\n   2. Participants must be neurologically stable off systemic corticosteroids for at least 2 weeks prior to trial entry\n2. Ongoing Grade 2 or greater treatment related toxicity due to tebentafusp\n3. Prior treatment with a PI3Kδ inhibitor\n4. Prior Grade 4 cytokine release syndrome related to Tebentafusp\n5. Systemic treatment with steroids or any other immunosuppressive drug use within 2 weeks of the planned first dose of program intervention, with the following exceptions:\n\n   1. Treatment for well-controlled and asymptomatic adrenal insufficiency is permitted, but replacement dosing is limited to prednisone ≤ 10 mg daily or the equivalent.\n   2. Local or topical steroid therapies (eg, optic, ophthalmic, intra- articular, or inhaled medications) are acceptable.\n   3. Premedication for allergy to contrast reagent.\n6. Any relevant medical condition, which in the opinion of the treating physician, would prevent the participant enrolling into the Program due to concerns related to safety, compliance with procedures, or interpretation of program results.\n7. Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications.\n8. Chronic viral infections as indicated below. NOTE: Testing for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) status prior to enrollment is not necessary unless clinically indicated.\n9. Known HIV infection unless all of the following are applicable:\n\n   1. Receiving an approved, stable, effective combination antiretroviral therapy regimen for ≥3 months prior to the planned first study intervention\n   2. CD4 T-cell count \\>350 cells\u002Fµl\n   3. CD4 T-cell nadir (lowest historical count) \\\u003C 350 cells\u002Fµl\n   4. Viral load confirmed as \\\u003C50 copies\u002Fml during Screening.\n10. Known HBV infection, unless on stable anti-viral therapy for \\> 4 weeks prior to the planned first dose of program intervention and viral load confirmed as undetectable during Screening.\n11. Known HCV infection, unless the participant has received curative treatment, and viral load was confirmed as undetectable during Screening.\n12. Participant with an out-of-range Screening laboratory values defined as shown below. NOTE: Hematology evaluations must be performed ≥ 7 days from any blood or blood product transfusion and ≥ 14 days from any dose of hematologic growth factor.\n\n    1. Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) \\\u003C 30 mL\u002Fminute.\n    2. Total bilirubin \\> 1.5 × ULN, except for patients with Gilbert's syndrome who are excluded if total bilirubin \\> 3.0 × ULN or direct bilirubin \\> 1.5 × ULN.\n    3. Alanine aminotransferase \\> 5 × ULN in the presence of liver metastases; \\> 3 X ULN if not\n    4. Aspartate aminotransferase \\> 5 × ULN in the presence of liver metastases ; \\> 3 X ULN if not\n    5. Platelet count \\\u003C 75 × 109\u002FL\n    6. Hemoglobin \\\u003C 9 g\u002FdL\n13. Clinically significant cardiac disease or impaired cardiac function, including any of the following:\n\n    1. Congestive heart failure (New York Heart Association Class ≥ 3)\n    2. QTcF\\>470msec at baseline\n    3. Uncontrolled hypertension defined as systolic blood pressure \\[BP\\] \\> 160 mmHg or diastolic BP \\> 110 mmHg with the following requirements:\n    4. If initial measurement is elevated, additional assessments should be taken where each assessment is the mean value of 3 measurements taken at least 5 minutes apart.\n    5. Eligibility is based on the average of at least 2 assessments taken at least 1 hour apart.\n    6. Acute myocardial infarction or unstable angina pectoris \\\u003C 6 months prior to the planned first dose of program intervention.","ALL",{"count":58,"type":21},8,[60],"PHASE1","This is a combination study of Tebentafusp and the PI3Kdelta inhibitor, Roginolisib",[63],"Uveal Melanoma, Metastatic",[65,66],"tebentafusp","Roginolisib",{"date":68,"type":39},"2026-04-23",{"date":70,"type":39},"2026-02-01",{"date":72,"type":21},"2029-12-01",{"name":45,"class":46},2,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":96,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":47},"100325826","phase-2-bipolar-androgen-therapy--carboplatin-in-mcrpc-100325826","NCT03522064","Bipolar Androgen Therapy + Carboplatin in mCRPC","High Dose Testosterone + Carboplatin in Men With Advanced Prostate Cancer","HiTeCH","Inclusion Criteria:\n\n1. Males with histologically confirmed adenocarcinoma of the prostate\n2. Confirmed HRD (Homologous recombination defect) in germline and\u002For somatic DNA analysis (tumour or blood), by a validated assay (see Appendix 1). Mutations in HR genes not listed in appendix 1 will be considered in literature suggests pathogenicity. A maximum of 10 uncharacterised or heterozygous mutations will be included.\n3. Age ≥ 18 years\n4. ECOG performance status ≤ 1\n5. Rising PSA confirmed on two sequential tests ≥1 week apart and a minimum value of 2 ug\u002FL despite castrate levels of testosterone\n6. Serum testosterone \\\u003C 1.7 nmol\u002FL and on an LHRH agent or post orchidectomy ≥ 1 year.\n7. Washout of ≥ 4 weeks from prior line of treatment, radiotherapy or surgery (aside from LHRH agent)\n8. Adequate bone marrow function (platelets \\> 100 x 109\u002FL, ANC \\> 1.5 x 109\u002FL, Hb \\>100)\n9. Adequate liver function (ALT\u002FAST \\\u003C 1.5 x ULN, bilirubin \\\u003C 2 x ULN)\n10. Adequate renal function (creatinine clearance \\> 50 ml\u002Fmin)\n11. Adequate cardiac function and reserve after cardiology assessment\n12. Archived tissue sample available or willingness to undergo fresh biopsy\n13. Willing and able to comply with all study requirements, including treatment, timing and\u002For nature of required assessments\n14. Signed, written informed consent\n\nExclusion Criteria:\n\n1. Contraindications to investigational product\n2. Pain due to metastatic prostate cancer requiring opioid analgesics\n3. Evidence of disease progression in sites or extent that, in the opinion of the investigator, would put the patient at risk from testosterone therapy and its potential for initial tumour flare (eg: femoral metastasis at risk of fracture, ureteric obstruction due to nodal disease or cord compression due to spinal metastases).\n4. Previous treatment with platinum chemotherapy and\u002For a PARP inhibitor. However up to 8 men with prior treatment to these agents will be included as an exploratory cohort.\n5. Life expectancy of less than 3 months.\n6. Brain metastases or leptomeningeal disease\n7. History of thromboembolic event and not currently on anticoagulation\n8. Prior myocardial infarction or unstable angina within 2 years of study entry\n9. Haematocrit ≥ 50%, untreated severe obstructive sleep apnoea or poorly controlled heart failure (NYHA \\>1)\n10. History of another malignancy within 5 years prior to registration. Patients with a past history of adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or superficial transitional cell carcinoma of the bladder are eligible. Patients with a history of other malignancies are eligible if they have been continuously disease free for at least 5 years after definitive primary treatment.\n11. Concurrent illness, including severe infection that may jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety.\n12. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse.",{"count":84,"type":21},30,[86],"PHASE2","The purpose of this study is to determine the efficacy of BAT and carboplatin in men with metastatic castrate-resistant prostate cancer (mCRPC).",[89,90],"Castration-resistant Prostate Cancer","Homologous Recombination Deficiency",[92,93,94,95],"Castrate-resistant prostate cancer","bipolar androgen therapy","homologous recombination deficiency","BRCA",{"date":68,"type":39},{"date":98,"type":39},"2018-07-30",{"date":100,"type":21},"2027-12-30",{"name":45,"class":46},{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":56,"minAge":18,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":112,"conditions":113,"keywords":117,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":74},"100597852","phase-1-adding-il-2-to-tebentafusp-to-eradicate-cancer-progression-100597852","NCT07063875","Adding IL-2 to Tebentafusp to Eradicate Cancer Progression","Supplementing With IL-2 to Verifiably eRadicate Radiological Progression","SILVER","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed metastatic UM or unresectable UM patients\n2. HLA-A\\*02:01 positive\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n4. RECIST 1.1 defined progression on single-agent Tebentafusp, with no other intervening systemic therapies\n\nExclusion Criteria:\n\n1. Presence of untreated or symptomatic central nervous system (CNS) metastases, leptomeningeal disease, or cord compression. (NOTE: Participants with treated CNS lesions may enroll provided all of the following apply: Treated CNS lesions must be radiographically stable for ≥ 4 weeks after intervention (surgery and\u002For radiation). Participants must be neurologically stable off systemic corticosteroids for at least 2 weeks prior to trial entry, AND Greater than 14 days elapsed between the last dose of previous Tebentafusp and first dose of IL-2 on trial)\n2. Systemic treatment with steroids or any other immunosuppressive drug use within 2 weeks of the planned first dose of program intervention, with the following exceptions: Treatment for well-controlled and asymptomatic adrenal insufficiency is permitted, but replacement dosing is limited to prednisone ≤ 10 mg daily or the equivalent; Local steroid therapies (eg, optic, ophthalmic, intra- articular, or inhaled medications) are acceptable.\n3. Any relevant medical condition, which in the opinion of the treating physician, would prevent the participant enrolling into the Program due to concerns related to safety, compliance with procedures, or interpretation of program results.\n4. Chronic viral infections as indicated below. NOTE: Testing for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) status prior to enrollment is not necessary unless clinically indicated.",{"count":58,"type":21},[60,86],"A recent clinical trial found that after 36 months, patients taking tebentafusp had a median survival of 21.6 months, compared to 16.9 months for those in the control group. Since recruitment for tebentafusp in metastatic uveal melanoma (mUM) has ended, a new trial is starting to test whether adding IL-2 can help overcome resistance to tebentafusp and improve its effectiveness.\n\nThis study aims to answer:\n\n1. Can combining tebentafusp with IL-2 improve tumor response and overall survival?\n2. What are the benefits and side effects of this combination therapy?\n\nAll participants will receive both IL-2 and tebentafusp in a 28-day treatment cycle. The dosing schedule is as follows:\n\nCycle1:\n\nDay1-3 IL-2 Day4 Tebentafusp Day 10 IL-2 Day 11 Tebentafusp Day 17 IL-2 Day 18 Tebentafusp Day 24 IL-2 Day 25 Tebentafusp\n\nCycle 2 \\& thereafter Day 1 IL-2 Day 2 Tebentafusp Day 8 IL-2 Day 9 Tebentafusp Day 15 IL-2 Day 16 Tebentafusp Day 22 IL-2 Day 23 Tebentafusp",[114,115,116],"Uveal Melanoma","Metastatic Uveal Melanoma","Metastatic Uveal Melanoma in the Liver",[118,119,120,121],"metastatic uveal melanoma","Immunotherapy","Treatment resistance","Combinational immunotherapy","2025-07-02",{"date":124,"type":39},"2025-07-14",{"date":126,"type":39},"2025-06-01",{"date":128,"type":21},"2027-09",{"name":45,"class":46},{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":56,"minAge":18,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":22,"phases":140,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":47},"100435206","phase-1-seviteronel-in-combination-with-chemotherapy-in-androgen-receptor-positive-metastatic-triple-negative-breast-cancer-100435206","NCT04947189","Seviteronel in Combination With Chemotherapy in Androgen-receptor Positive Metastatic Triple-negative Breast Cancer","4CAST: A Phase 1b Dose Exploration and Dose Expansion, Open-label, Single-centre Study Evaluating the Safety and Efficacy of INO-464 in Combination With Chemotherapy in Patients With metASTatic Breast Cancer","4CAST","Inclusion Criteria:\n\n* Signed written and voluntary informed consent.\n* Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.\n* Age 18 years or older male or female.\n* Eastern Cooperative Oncology Group Performance Status of 0 or 1\n* At least 4 weeks washout period from previous line of treatment, 2 weeks from radiotherapy\n* Adequate haematologic and organ function within 14 days before the first study treatment on cycle1, day 1\n* Life expectancy of at least 3 months\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of \\\u003C1% per year during the treatment period and for at least 28 days after the last dose of seviteronel or, 6 months after the last dose of chemotherapy whichever occurs later.\n* Part 1: Histological or cytological-based diagnosis of breast cancer. Any of the three major subtypes of breast cancer is permitted for the phase 1b study, i.e., hormone receptor positive breast cancer i.e. oestrogen and\u002For progesterone positive in greater than 1% of cells by immunohistochemistry (IHC), or human epidermal growth factor receptor (HER2) positive breast cancer, i.e., IHC 3+ or in situ hybridisation (ISH) positive according to standard ASCO\u002FCAP guidelines or triple-negative breast cancer, i.e., HER2-negative by ASCO\u002FGAO Guidelines and \\\u003C1% expression of estrogen and\u002For progesterone receptor by IHC.\n* Part 2: Histological or cytological-based diagnosis of triple-negative breast cancer. The tumor must be HER2-negative by ASCO\u002FGAO Guidelines and \\\u003C1% expression of estrogen and \u002For progesterone receptor by IHC.\n\n  o The tumor must also show androgen receptor positivity (i.e., AR\\>0%) by IHC or gene classifier (molecular testing).\n* Measurability of lesion: have at least 1 measurable lesion assessable using standard techniques by RECIST v1.1\n* Patients must have advanced or recurrent breast cancer pre-inclusion number 8, for whom docetaxel is considered an appropriate treatment option.\n\nExclusion Criteria:\n\n* Inability to comply with study and follow-up procedures.\n* History of malabsorption syndrome or other condition that would interfere with enteral absorption or results in the inability or unwillingness to swallow pills.\n* Active infection requiring antibiotics.\n* Other invasive malignancy within 2 years except for malignancies determined to have low recurrence potential in discussion with study PI.\n* Known active tuberculosis.\n* Female patients who are pregnant or breast-feeding.\n* Male or female patients of reproductive potential who are not willing to use effective birth control from screening to 90 days post treatment.\n* Women of childbearing potential (who are not postmenopausal within 12 months of non-therapy induced amenorrhea, nor surgically sterile) must have a negative serum pregnancy test result within 3 days prior to initiation of study treatment.\n* Uncontrolled intercurrent illness, including psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events, or compromise the ability of the subject to give written informed consent.\n* History or current evidence of HIV infection.\n* Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis (e.g., positive for hepatitis B surface antigen \\[HBsAg\\] or hepatitis C virus \\[HCV\\] antibody at screening), current drug or alcohol abuse, or cirrhosis:\n* Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen antibody test) are eligible.\n* Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 of Cycle 1 or anticipation of need for a major surgical procedure during the course of the study\n* Placement of a vascular access device is not considered major surgery.\n* Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications\n* Patients with symptomatic central nervous system (CNS) metastasis and\u002For carcinomatous meningitis. Patients with treated CNS metastases are eligible for this study if they are not receiving corticosteroids and\u002For anticonvulsants for at least 7 days prior to first dose of study treatment, and their disease is asymptomatic and radiographically stable for at least 30 days prior to consent by repeat imaging (repeat imaging should be performed during study screening).\n* Unresolved, clinically significant toxicity NCI CTCAE v5.0 grade 2 or higher, from prior therapy, except for alopecia, endocrinopathy on stable hormonal replacement, and others as approved by study PI.\n* Patients who have received palliative radiation treatment to peripheral sites (e.g., bone metastases) for pain control and whose last treatment was completed 14 days prior to Day 1 of Cycle 1 may be enrolled in the study if they have recovered from all acute, reversible effects.\n* Uncontrolled pleural effusion, pericardial effusion, or ascites.\n* Known hypersensitivity or contraindication to any component of the study treatment.\n* Administration of any investigational treatment within 30 days or 5 half-lives (whichever is longer) prior to receiving the first dose of study treatment",{"count":139,"type":21},65,[60,86],"To facilitate the clinical testing of seviteronel and dexamethasone (SEVI-D) in combination with docetaxel in androgen receptor (AR) positive triple-negative breast cancer.",[143],"Triple Negative Breast Cancer",[145],"Androgen receptor positive","2025-05-12",{"date":148,"type":39},"2025-05-15",{"date":150,"type":39},"2022-11-01",{"date":152,"type":21},"2027-12",{"name":45,"class":46},{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":22,"phases":163,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":47},"100585843","phase-2-comparative-performance-of-64copper-64cu-sar-bis-psma-vs-68ga-psma-11-pet-ct-for-the-detection-of-prostate-cancer-recurrence-in-the-setting-of-biochemical-failure-following-radical-prostatectomy-100585843","NCT06907641","Comparative Performance of 64Copper [64Cu]-SAR-bis-PSMA vs 68Ga PSMA-11 PET CT for the Detection of Prostate Cancer Recurrence in the Setting of Biochemical Failure Following Radical Prostatectomy","Co-PSMA","Inclusion Criteria:\n\n* Male patients aged 18 or above\n* Ability to provide informed consent documentation indicating that they understand the purpose of, and procedures required for the study, and are willing to participate in the study.\n* Prior radical prostatectomy for confirmed adenocarcinoma on histopathology.\n* Rising PSA (0.20 - 0.75 ng\u002FmL) following radical prostatectomy with no prior salvage radiotherapy.\n* 68Ga PSMA-11 PET\u002FCT within the last 4 weeks for prostate cancer biochemical recurrence.\n\nExclusion Criteria:\n\n* Prior, or contraindication to, salvage radiotherapy for biochemically recurrent prostate cancer.\n* History of current active malignancy as per investigator discretion other than prostate cancer.\n* Known or expected hypersensitivity to 64Cu-SAR-bisPSMA\n* Systemic therapy for metastatic prostate cancer including androgen deprivation therapy.",{"count":162,"type":21},50,[86],"The goal of this clinical trial is to compare 64Cu-SAR-bisPSMA PET\u002FCT and 68Ga PSMA-11 PET\u002FCT in men with biochemical failure following radical prostatectomy. The main questions it aims to answer are:\n\n* Is there a difference in the number of lesions of prostate cancer recurrence detected between the 64Cu-SAR-bisPSMA PET\u002FCT and 68Ga PSMA-11 PET\u002FCT scans.\n* What is the diagnostic accuracy of 64Cu-SAR-bisPSMA PET\u002FCT compared to 68Ga PSMA-11 PET\u002FCT using a standard of care comparator.\n* Evaluate the magnitude of clinical management change when using 64Cu-SAR-bisPSMA additional to standard of care imaging (68Ga PSMA-11).\n\nParticipants will:\n\n* have 3 visits: 1) standard of care 68Ga PSMA-11 dose and PET\u002FCT scan; 2) 64Cu-SAR-bisPSMA dose and PET\u002FCT; 3) 64Cu-SAR-bisPSMA PET\u002FCT only\n* have standard of care blood test either at Visit 1 or Visit 2",[166],"Prostate Cancer (Post Prostatectomy)",[168,169,170,159,171,172,173,174,175,176],"Prostate Cancer","Salvage Radiotherapy","Prostatectomy","CLP11","Prostate Cancer Recurrence","Biochemical Failure","Radical Prostatectomy","Copper","PET scan","2025-04-01",{"date":179,"type":39},"2025-04-02",{"date":181,"type":39},"2024-11-21",{"date":183,"type":21},"2025-11",{"name":45,"class":46},""]