Prostate Cancer

Condition: PSMA-positive Metastatic Castration-resistant Prostate Cancer (mCRPC)

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07660211

Sponsor: VitsGen Therapeutics Inc.

Phase: Phase 1

Eligibility:

• Age: minimum 18 Years maximum 80 Years
• Gender: Male

Inclusion Criteria:

1. Male participants aged 18 years (inclusive) to 80 years (exclusive) at the time of signing the informed consent.
2. Histologically or cytologically confirmed prostate cancer with no standard treatment options available, or failure/intolerance to standard therapies, or inability to access standard treatment.
3. During the screening period, imaging examinations (within 4 weeks before administration) showed the presence of ≥1 metastatic lesion.
4. ECOG Performance Status score: 0 to
5. Expected survival time exceeds 6 months.
6. All clinically significant toxicities related to prior anti-tumor therapy (e.g., chemotherapy, radiotherapy, etc., excluding Luteinizing Hormone-Releasing Hormone (LHRH) analog therapy) must have resolved to ≤ Grade 1, except for toxicities deemed safe and manageable by the investigator, such as alopecia, peripheral neuropathy ≤ Grade 2, etc. (CTCAE V6.0).
7. The participant must be fully informed about the study and voluntarily provide written informed consent prior to participation.
8. The participant must be capable of understanding and complying with the requirements of the trial protocol.
9. The participant must use a condom during sexual activity throughout the study period and for 14 weeks after the last dose of study treatment to prevent pregnancy in partners and potential exposure of partners to the investigational product g via semen. Additionally, the participant should refrain from sperm donation during the specified timeframe above.

Exclusion Criteria:

1. Having received anti-tumor therapies such as chemotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks prior to the first dose of the investigational product, or planning to receive such therapies during the study period.
2. Having received systemic or local radionuclide therapy within 3 months prior to the first dose.
3. Having received other investigational product treatments not yet approved within 4 weeks prior to the first dose of the investigational product, or within five half-lives of that.
4. Having undergone major organ surgery (excluding needle biopsy) or experienced significant trauma within 4 weeks prior to the first dose of the investigational product, or requiring elective surgery during the trial period.
5. Having been diagnosed with other malignancies within the past 2 years (participants with a prior history of malignancy who have received adequate treatment and have remained disease- and treatment-free for over 3 years prior to enrollment are eligible, as are patients with adequately treated non-melanoma skin cancer or superficial bladder cancer).
6. Having symptomatic spinal cord compression or clinical/imaging findings suggestive of impending spinal cord compression.
7. Known allergy to structural analogs of this product or other excipients.
8. Having a history of immunodeficiency, including a positive HIV test result, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; a history of severe autoimmune diseases deemed unsuitable for enrollment by the investigator; or requiring immunosuppressive therapy for allogeneic organ transplantation.
9. Having severe infections (requiring intravenous antibiotics, antifungals, or antivirals according to clinical practice guidelines), active hepatitis A, active hepatitis B (HBV DNA ≥2000 IU/mL or 10^4 copies/mL; prophylactic antiviral therapy other than interferon is allowed), active hepatitis C (anti-HCV positive and HCV-RNA above the lower limit of detection), or active syphilis infection.
10. Having uncontrolled third-space fluid accumulations (such as significant pleural effusion, ascites or pericardial effusion) deemed unsuitable for enrollment by the investigator.
11. Having a clear history of neurological or psychiatric disorders, including epilepsy or dementia.
12. Other reasons considered by the investigator to make the participant unsuitable for participation in this clinical study.

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Condition: Breast Cancer, Prostate Cancer, Colorectal Cancer, GRPR-positive Solid Tumors

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07661641

Sponsor: Alpha-9 Oncology USA Inc.

Phase: Phase 1

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

• Participant has provided written informed consent prior to any study-specific procedure.
• Age ≥ 18 years old.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• Have measurable target lesion per RECIST v1.1.
• Progression from, intolerant to, or ineligible for (due to unavailability or contraindication) local standard of care therapies and have one of the following locally advanced or metastatic tumor types: prostate cancer; HR+/HER2- breast cancer; colorectal cancer; and GRPR-positive solid tumors.
• Have GRPR-expressing disease as confirmed by PET / CT or SPECT imaging.
• Adequate organ function within 14 days of first administration of investigational therapeutic product.
• At least 4 weeks from prior major surgery.

Exclusion Criteria:

• Received anticancer treatment including but not limited to chemotherapy, antibody therapy, immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, or experimental drugs ≤ 14 days prior (≤ 28 days prior in case of checkpoint inhibitor therapy and other antibody therapies) or 5 half-lives, (t1/2) whichever is shorter, to the administration of therapeutic investigational product.
• History of uncontrolled allergic reactions and/or known or expected hypersensitivity to a peptide-based imaging or therapeutic agent or any excipient present in either of the therapeutic investigational products.
• Major surgery within 4 weeks of planned first dose of the therapeutic investigational product.
• Prior external beam radiation therapy to more than 25% of the bone marrow.
• Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
• Any active infection.

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Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07231627

Sponsor: University of Arkansas

Eligibility:

• Age: minimum 40 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• 1. 40 years of age or older. 2. A recent pMRI performed within last 12 weeks 3. Eastern Cooperative Oncology Group (ECOG) performance status 0
• 1. 4. Any patient with PIRADS 3 lesions per pMRI, AND elevated PSA ("=> 3.0 ng/ml" for patients between 40 and 75 years old, and "=> 4.0 ng/ml" for the patients older than 75 years). 5. Patients with PIRADS 1-2 lesions per pMRI, AND elevated PSA ("=> 3.0 ng/ml" for patients between 40 and 75 years old, and "=> 4.0 ng/ml" for the patients older than 75 years), AND at least one of the following: 1. High PSA density (0.15 ng/ml/g or higher), 2. suspicious DRE, 3. a positive/high-risk blood or urine biomarker test, 4. high-risk ancestry (Black/African American), 5. those with germline mutations that increase the risk for prostate cancer, 6. significant personal medical history, 7. significant family history, 8. persistent and significant increase in PSA levels (persistently elevated PSA for at least 12 months with an increase of at least 100% or more within 24 months, last level confirmed twice).

Exclusion Criteria:

1. Patients younger than 18 years old.
2. Any patient with PIRADS 4-5 lesion per pMRI.
3. Any patient with known csPCa (GS ≥7 (3+4)) per biopsy.
4. Any patient with PCa and managed with active surveillance, surgery or radiation. a. (Patients who never scanned with pMRI before, had GS 6 (3+3) PCa only per systematic biopsy, and currently need confirmatory prostate biopsy will be allowed to enroll in the trial).
5. Medically unfit for anesthesia.
6. Any history of allergic reactions attributed to contrast agents, or other compounds of similar chemical compositions.
7. Any medical history preventing pMRI or prostate biopsy.
8. Any medical condition distorting quality of pMRI such as artificial hip prosthesis, and excessive rectal gas.
9. Any other condition that, in the opinion of the investigator, might interfere with the safe conduct of the study. Inclusion of Women and Minorities: All participants will be men without previous diagnosis for PCa. Men of all ethnic groups and races are eligible for the study. Thus, women will not be included in this study.

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Condition: PSA Progression, PSA

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07516223

Sponsor: Shanghai East Hospital

Eligibility:

• Age: minimum 45 Years maximum N/A
• Gender: Male

Inclusion Criteria:

1. Age ≥ 45 years. Serum PSA level ≥ 4.0 ng/ml. High-risk MRI findings: Presence of at least one lesion with a PI-RADS score of 4 (Likely) or 5 (Highly Likely) according to v2.1 guidelines
2. Fitness for transperineal prostate biopsy under local or general anaesthesia. Competency to provide informed consent.

Exclusion Criteria:

1. History of prior prostate biopsy (to ensure baseline risk homogeneity). Prior treatment for prostate cancer or use of 5-alpha reductase inhibitors (5-ARIs) within 6 months. Candidates who have explicitly opted for focal therapy prior to biopsy (where systematic mapping remains mandatory). Contraindications to MRI (e.g., incompatible implants, severe renal impairment). Active urinary tract infection or acute prostatitis.

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Condition: Metastatic Hormone-sensitive Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07333066

Sponsor: Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD

Phase: Phase 3

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

1. Written informed consent. Each patient must sign an informed consent form (ICF) indicating that he understands the purpose of and procedures, required for the study, and is willing to participate in the study.
2. Patient must be a man ≥18 years of age.
3. Histologically or cytologically confirmed adenocarcinoma of prostate.
4. Metastatic hormone-sensitive prostate cancer.
5. PSA >5 ng/ml at diagnosis of metastatic disease.
6. Patients eligible to continue treatment with apalutamide and ADT and without contra-indication to receive docetaxel.
7. Patients with at least 24 weeks and no more than 30 weeks of apalutamide.
8. Patients with a maximum of 12 weeks ADT before apalutamide initiation.
9. Lack of achievement of deep PSA response after 24 weeks and no more than 30 weeks of apalutamide. Deep PSA response is defined as PSA ≤ 0.2 ng/ml or PSA response ≥ 90% in combination with a PSA ≤4 ng/ml. Therefore, a non-deep PSA response is defined as PSA > 0.2 ng/ml in combination with a PSA response < 90%, or a PSA response ≥90% in combination with a PSA > 4 ng/ml.
10. Patients who have not progressed to apalutamide.
11. Patients that are tolerating adequately apalutamide 240 mg daily and with no toxicity higher than G1 at inclusion.
12. Be able to swallow whole apalutamide film-coated tablets.
13. Eastern Cooperative Oncology Group (ECOG) performance status ≤
14. Clinical laboratory values at screening:
15. hemoglobin ≥10.0 g/dL,
16. absolute neutrophil count ≥1.5 × 10*9/L,
17. platelet count ≥100 × 109/L, The patient must not have received any growth factor within 4 weeks or a blood transfusion within 7 days of the hematology laboratory sample obtained at screening
18. serum alanine aminotransferase and/or aspartate transaminase ≤1.5 × the upper limit of normal (ULN),
19. total bilirubin ≤ ULN,
20. creatinine ≤2.0 × ULN
21. Sexually active men must agree to use an external condom as an effective barrier method and refrain from sperm donation, and their female partners of childbearing potential must practice a highly effective method of contraception during and for 3 months after treatment with apalutamide and for 6 months after treatment with docetaxel.

Exclusion Criteria:

1. Presence of neuroendocrine histology.
2. Apalutamide treatment started more than 30 weeks before inclusion.
3. Progression disease by any means, including radiographic, clinical or serological at inclusion.
4. Patient who achieves deep PSA response on apalutamide treatment before randomization.
5. Previous androgen-pathway receptor inhibitors, including enzalutamide, darolutamide, abiraterone or other ARPI. Previous treatment with first generation antiandrogens (i.e. bicalutamide) is allowed.
6. Chemotherapy or immunotherapy for prostate cancer before randomization.
7. Treatment with radiotherapy (external-beam radiation therapy, brachytherapy, or radiopharmaceuticals) within 2 weeks before randomization.
8. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs.
9. Contraindication to both computed tomography and magnetic resonance imaging contrast agent.
10. Prolonged QT interval defined as QTcF ≥ 480 ms at screening, based on the mean of triplicate 12-lead ECGs performed after at least 5 minutes of rest. Patients with congenital long QT syndrome will also be excluded.
11. Any of the following within 6 months before randomization:
12. stroke,
13. myocardial infarction,
14. severe or unstable angina pectoris,
15. uncontrolled arrhythmia,
16. coronary or peripheral artery bypass graft, or
17. congestive heart failure (New York Heart Association class III or IV)
18. Peripheral neuropathy ≥ grade
19. Uncontrolled hypertension, indicated by resting systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg despite medical management.
20. Prior malignancy, except for adequately treated basal-cell or squamous-cell carcinoma of the skin or superficial bladder cancer that had not spread behind the connective-tissue layer (i.e., stage pTis, pTa, or pT1) or any cancer for which treatment had been completed ≥5 years before randomization and from which the patient was disease-free.
21. A gastrointestinal disorder or procedure that was expected to interfere significantly with absorption of study drug.
22. Active viral hepatitis, known human immunodeficiency virus infection with detectable viral load, or chronic liver disease requiring treatment.
23. Previous (within 28 days before the start of study drug or 5 half-lives of the investigational treatment of the previous study, whichever was longer) or concomitant participation in another clinical study with investigational medicinal products.
24. Any other serious or unstable illness or medical, social, or psychological condition that could jeopardize the safety of the patient and/or their compliance with study procedures or might interfere with their participation in the study or evaluation of the study results.

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Condition: Prostate Cancer

Study Type: Observational [Patient Registry]

Clinical Trials Identifier NCT 8-digits: NCT07645872

Sponsor: EDAP TMS S.A.

Phase:

Eligibility:

• Age: minimum N/A maximum N/A
• Gender: Male

Inclusion Criteria:

• Being treated for prostate cancer with the Focal One device
• Patient does not object and consent* to the collection of clinical data in the registry

Exclusion Criteria:

• Patient deprived of liberty following a judicial or administrative decision
• Patient under guardianship or curatorship * if applicable according to local regulation

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Condition: Breast Cancer, Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07441889

Sponsor: University of Virginia

Phase: Phase 1/Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

• 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Age ≥ 18 years at the time of signing informed consent 4. Expected survival ≥ 3 months in the judgment of the investigator 5. ECOG PS 0-1 6. Adequate Organ Function per the following criteria (within 10 days of study registration):
• Absolute lymphocyte count ≥ 400/mm3
• Absolute neutrophil count ≥ 1000/mm3
• Platelets ≥ 75,000/mm3
• Hemoglobin ≥ 9g/dL
• Serum creatinine < 2.0 mg/dL OR measured or calculated creatinine clearance ≥ 50 ml/mm
• Total bilirubin ≤ mg/dL
• Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) < 5.0 times normal 7. Agreement to adhere to Lifestyle Considerations throughout study duration 8. A diagnosis of either of the following: a. Prostate Cancer: i. Histological and/or cytological confirmation of prostate adenocarcinoma. ii. Participants must have progressive mCRPC at screening iii. Serum testosterone levels <50 ng/dL during screening. iv. Must have progressed on at least one prior ARPI (abiraterone acetate, enzalutamide, apalutamide, or darolutamide). v. Participants must have ≥1 metastatic lesion that is present on baseline CT, MRI, or bone scan obtained ≤28 days prior to registration. b. Breast Cancer i. Histological and/or cytological confirmation of invasive breast cancer. ii. Participants must have previously treated metastatic breast cancer at screening. Metastatic breast cancer must be evaluable by RECIST 1.1 criteria. iii. Must have progressed on at least two prior endocrine or targeted therapies or at least two lines of cytotoxic chemotherapy. If HER2 positive, then must have progressed on or been intolerant of at least one HER2 targeted therapy. iv. Participants must have ≥1 metastatic lesion that is present on baseline CT, MRI, or bone scan obtained ≤28 days prior to registration. Exclusion Criteria: 1. Pregnancy (must have negative pregnancy test within 7 days prior to study registration) or lactation 2. History of a recent myocardial infarction (within one year) or a past myocardial infarction (more than one year prior to enrollment) who are actively requiring nitroglycerine more than once per week 3. Inadequate cardiac function, as defined as any of the following:
• Uncontrolled angina or severe ventricular arrhythmias
• Clinically significant pericardial disease
• History of myocardial infarction (MI) in the last year before registration
• Class 3 or higher New York Heart Association Congestive Heart Failure 4. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to study registration. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 5. Serious non-healing wound, ulcer, bone fracture, major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to registration 6. Active liver disease such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis 7. Is HIV positive or has evidence of active Hepatitis C virus or active Hepatitis B virus. 8. Active bleeding or a pathological condition that is associated with a high risk of bleeding (therapeutic anticoagulation is allowed) 9. Has an active infection requiring systemic therapy 10. A serious uncontrolled medical disorder that in the opinion of the Investigator may be jeopardized by the treatment with protocol therapy 11. Has a known history of active TB (Bacillus Tuberculosis) 12. Has received a live vaccine within 30 days of study registration. 13. Treatment with any investigational agent within 3 weeks prior to study registration 14. Active second malignancy requiring systemic treatment. Exceptions include basal cell carcinoma of the skin, treated cervical cancer, and squamous cell carcinoma of the skin 15. Has active autoimmune disease that has required systemic treatment in the 2 years prior to registration (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 16. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator. 17. Patient may be excluded if, in the opinion of the PI and investigator team, the patient is not capable of being compliant Additional Exclusion Criteria for Patients with Prostate Cancer: 1. Has small cell neuroendocrine carcinoma (pure or mixed) on prior or current histologic evaluation of primary or metastatic lesions 2. Has an actionable BRCA1 or BRCA2 alteration, for which approved therapies are available, e.g., PARP inhibitors, unless these therapies are not appropriate for the participant as determined by the investigator or the participant refuses such therapy. Participants with one of these mutations and who have progressed on targeted therapy are eligible. Additional

Exclusion Criteria:

• 1. Pregnancy (must have negative pregnancy test within 7 days prior to study registration) or lactation 2. History of a recent myocardial infarction (within one year) or a past myocardial infarction (more than one year prior to enrollment) who are actively requiring nitroglycerine more than once per week 3. Inadequate cardiac function, as defined as any of the following:
• Uncontrolled angina or severe ventricular arrhythmias
• Clinically significant pericardial disease
• History of myocardial infarction (MI) in the last year before registration
• Class 3 or higher New York Heart Association Congestive Heart Failure 4. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to study registration. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 5. Serious non-healing wound, ulcer, bone fracture, major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to registration 6. Active liver disease such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis 7. Is HIV positive or has evidence of active Hepatitis C virus or active Hepatitis B virus. 8. Active bleeding or a pathological condition that is associated with a high risk of bleeding (therapeutic anticoagulation is allowed) 9. Has an active infection requiring systemic therapy 10. A serious uncontrolled medical disorder that in the opinion of the Investigator may be jeopardized by the treatment with protocol therapy 11. Has a known history of active TB (Bacillus Tuberculosis) 12. Has received a live vaccine within 30 days of study registration. 13. Treatment with any investigational agent within 3 weeks prior to study registration 14. Active second malignancy requiring systemic treatment. Exceptions include basal cell carcinoma of the skin, treated cervical cancer, and squamous cell carcinoma of the skin 15. Has active autoimmune disease that has required systemic treatment in the 2 years prior to registration (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 16. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator. 17. Patient may be excluded if, in the opinion of the PI and investigator team, the patient is not capable of being compliant Additional Exclusion Criteria for Patients with Prostate Cancer: 1. Has small cell neuroendocrine carcinoma (pure or mixed) on prior or current histologic evaluation of primary or metastatic lesions 2. Has an actionable BRCA1 or BRCA2 alteration, for which approved therapies are available, e.g., PARP inhibitors, unless these therapies are not appropriate for the participant as determined by the investigator or the participant refuses such therapy. Participants with one of these mutations and who have progressed on targeted therapy are eligible. Additional Exclusion Criteria for Patients with Breast Cancer: 1. Has an actionable BRCA1 or BRCA2 alteration, for which approved therapies are available, e.g., PARP inhibitors, unless these therapies are not appropriate for the participant as determined by the investigator or the participant refuses such therapy. Participants with one of these mutations and who have progressed on targeted therapy are eligible. 2. Participants in visceral crisis at risk of immediately life-threatening complications in the short term, including participants with massive uncontrolled effusions (pleural, pericardial, and peritoneal), pulmonary lymphangitis, or liver involvement > 50%.

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Condition: Metastatic Cancer, Neoplasm, Prostate, Castrate-sensitive, Castrate-sensitive Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05422911

Sponsor: Sun Pharmaceutical Industries Limited

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Veterans must meet the following to be eligible to participate:
• Be willing and able to provide written informed consent for the trial.
• Age ≥18 years of age on day of signing informed consent.
• Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less (on a scale from 0 to 5, with higher scores indicating greater disability and a score of 5 indicating death).
• Histologically or cytologically confirmed adenocarcinoma of the prostate without morphologic evidence of small-cell features in either a recently obtained sample or in the archival sample at the time of diagnosis.
• Have previously begun within 120 days of randomization or will receive androgen-deprivation therapy with a gonadotropin releasing hormone agonist or antagonist or have undergone bilateral orchiectomy (i.e., medical, or surgical castration).
• Laboratory tests meet minimum safety requirements:
• Hepatic: AST ≤2.5 X institutional ULN, ALT ≤2.5 X institutional ULN, Total bilirubin ≤1.5X upper limit of normal (ULN) [except for subjects with documented Gilbert's disease in which case total bilirubin not to exceed 10X ULN].
• Renal: Creatinine clearance ≥30 ml/min or serum creatinine ≤1.8 mg/dl
• Hematological: Platelet count ≥100,000/mm^3; Hemoglobin >9 g/dL; ANC >1 X10^9/L
• Serum potassium >3 mEq/L

Exclusion Criteria:

• Subjects with any of the following will not be enrolled:
• Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, apalutamide or enzalutamide or darolutamide for the treatment of prostate cancer or participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (unless treatment was placebo).
• Treatment with hormonal therapy (e.g., androgen receptor inhibitors other than bicalutamide, estrogens, 5-alpha reductase inhibitors) or biologic therapy for prostate cancer (other than approved bone-targeting agents and GnRH agonist/antagonist therapy) within 4 weeks of randomization.
• History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke or significant brain trauma).
• Patients who are receiving any other investigational agents concurrently.
• Clinically significant heart disease as evidenced by New York Heart Association (NYHA) Class III-IV heart disease.
• Child-Pugh Class B and C

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Condition: Metastatic Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07200830

Sponsor: Alliance for Clinical Trials in Oncology

Phase: Phase 3

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• PRE-REGISTRATION (STEP 0): Patients must have histological, pathological, and/or cytological confirmation of prostate adenocarcinoma
• PRE-REGISTRATION (STEP 0): Patients must have a positive PSMA PET/CT scan (either gallium Ga 68 gozetotide [68Ga-PSMA-11], fluorine F 18 piflufolastat [18F- DCFPyl], or fluorine F 18 flotufolastat gallium [18F-rhPSMA-7.3]), as defined as uptake greater than liver with no PSMA negative measurable soft tissue disease
• PRE-REGISTRATION (STEP 0): PSA greater than 2.0 ng/mL
• PRE-REGISTRATION (STEP 0): Patients must have progressive mCRPC. Documented progressive mCRPC will be based on at least 1 of the following criteria:
• Serum PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 ng/mL
• Soft-tissue progression defined as an increase ≥ 20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or more new lesions
• Progression of bone disease: evaluable disease or new bone lesions(s) by bone scan (2+2 Prostate Cancer Clinical Trials Working Group 3 [PCWG3] criteria, Scher et al 2016)
• PRE-REGISTRATION (STEP 0): Patients must have prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (< 50 ng/dL or < 1.7 nmol/L)
• PRE-REGISTRATION (STEP 0): Patients must have received at least one androgen receptor pathway inhibitor (ARPI) (to include either apalutamide, darolutamide, enzalutamide, or abiraterone) * ARPI must be stopped at least 4 weeks prior to pre-registration
• PRE-REGISTRATION (STEP 0): Patients must not have previously received a taxane based chemotherapy regimen for mCRPC. Prior docetaxel for metastatic hormone-sensitive prostate carcinoma (mHSPC) or in the neoadjuvant or adjuvant setting is permitted if completed at least 12 months prior to pre-registration
• PRE-REGISTRATION (STEP 0): Patients must have recovered to ≤ grade 2 from all clinically significant toxicities related to prior therapies (i.e. prior chemotherapy, radiation, immunotherapy, etc.)
• PRE-REGISTRATION (STEP 0): Patients on a stable bisphosphonate or denosumab regimen for ≥ 30 days prior to pre-registration are eligible
• PRE-REGISTRATION (STEP 0): Previous treatment with strontium Sr-89 (strontium-89), samarium Sm-153 (samarium-153), rhenium Re 186 (rhenium-186), rhenium Re 188 (rhenium-188), radium Ra 223 (radium-223) or hemi-body irradiation within 6 months prior to pre-registration is not allowed. Previous PSMA-targeted radioligand therapy is not allowed
• PRE-REGISTRATION (STEP 0): Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy [including monoclonal antibodies]) within 28 days prior to pre-registration is not allowed
• PRE-REGISTRATION (STEP 0): Age ≥ 18 years
• PRE-REGISTRATION (STEP 0): Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
• PRE-REGISTRATION (STEP 0): Absolute neutrophil count (ANC) ≥ 1,500/mm^3
• PRE-REGISTRATION (STEP 0): Platelet count ≥ 100,000/mm^3
• PRE-REGISTRATION (STEP 0): Total bilirubin < 1.5 x upper limit of normal (ULN) or < 3 x ULN in patients with Gilbert's syndrome
• PRE-REGISTRATION (STEP 0): Creatinine clearance estimated glomerular filtration rate (eGFR) ≥ 40 mL/min/1.73m^2 using the Modification of Diet in Renal Disease (MDRD) equation
• PRE-REGISTRATION (STEP 0): No acute biliary or urinary obstruction
• PRE-REGISTRATION (STEP 0): Patients with treated/stable brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression * Patients with a history of CNS metastases must have received therapy (surgery, radiotherapy, gamma knife) and be neurologically stable, asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity. Patients with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired. For patients with parenchymal CNS metastasis (or a history of CNS metastasis), baseline and subsequent radiological imaging must include evaluation of the brain (MRI preferred or CT with contrast)
• PRE-REGISTRATION (STEP 0): Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial
• PRE-REGISTRATION (STEP 0): For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
• PRE-REGISTRATION (STEP 0): Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
• PRE-REGISTRATION (STEP 0): Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better
• PRE-REGISTRATION (STEP 0): No investigational agents within 28 days prior to pre-registration
• PRE-REGISTRATION (STEP 0): No other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy
• PRE-REGISTRATION (STEP 0): No known hypersensitivity to the components of the study therapy or its analogs
• PRE-REGISTRATION (STEP 0): No transfusion within 30 days of pre-registration
• PRE-REGISTRATION (STEP 0): No symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression
• PRE-REGISTRATION (STEP 0): Ability to read and comprehend English or Spanish
• REGISTRATION (STEP 1): Completion of 2 doses of 177Lu PSMA RLT
• REGISTRATION (STEP 1): PSA decline ≥ 50% between C1 D1 (screening) and C2 D22 +/-3 days
• REGISTRATION (STEP 1): ECOG Performance Status ≤ 2
• REGISTRATION (STEP 1): Absolute neutrophil count (ANC) ≥ 1,500/mm^3
• REGISTRATION (STEP 1): Platelet count ≥ 100,000/mm^3
• REGISTRATION (STEP 1): Creatinine clearance eGFR ≥ 40 mL/min/1.73m^2 using the Modification of Diet in Renal Disease (MDRD) equation

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Condition: Prostate Cancer

Study Type: Observational [Patient Registry]

Clinical Trials Identifier NCT 8-digits: NCT07455058

Sponsor: Francis Medical Inc.

Phase:

Eligibility:

• Age: minimum N/A maximum N/A
• Gender: Male

Inclusion Criteria:

• Candidate for Vanquish therapy per physician discretion or participant has completed a company-sponsored Vanquish therapy study.
• Participant is willing and able to provide written informed consent.

Exclusion Criteria:

• Contraindications per the Vanquish IFU
• Previously participated in VAPOR 2 study and is not planning to receive further Vanquish therapy.

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Condition: Prostate Cancer (Post Prostatectomy), Radiotherapy; Image-Guided, Prostate Cancer Non-Metastatic, Androgen Deprivation Therapy, Lymph Node Positive

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07477626

Sponsor: Sun Yat-sen University

Phase: Phase 3

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Age ≥ 18 years.
• Histologically confirmed adenocarcinoma of the prostate.
• Radical prostatectomy with pelvic lymph node dissection and pathologically confirmed positive pelvic lymph nodes (AJCC 8th edition: external iliac, internal iliac, obturator, presacral, periprostatic, and/or perirectal nodes).
• ECOG performance status 0-2.
• Started postoperative GnRH agonist or antagonist therapy for less than 1 year if receiving postoperative androgen deprivation therapy*.
• Adequate major organ function, defined as: Hemoglobin ≥ 90 g/L Platelet count ≥ 75 × 10⁹/L Total bilirubin ≤ 3 × ULN AST or ALT ≤ 5 × ULN
• Use of effective contraception during the study and for 3 months after.
• Written informed consent provided, with willingness and ability to comply with study visits, treatments, and procedures.
• Prior postoperative ARAT use ≤ 3 months is eligible after treatment discontinuation.

Exclusion Criteria:

• Measurable pelvic recurrence on postoperative MRI or CT (RECIST 1.1, including prostate bed and lymph nodes).
• Radiographically confirmed distant metastasis (M1a, M1b, or M1c).
• Neoadjuvant hormonal therapy > 3 months before prostatectomy.
• Malignancy within 5 years that may interfere with study safety or efficacy assessments.
• Castration-resistant prostate cancer (CRPC) prior to enrollment per 2025 EAU criteria
• Prior radiotherapy overlapping irradiation fields that may compromise normal tissue.
• Serious comorbidities affecting study treatment.
• Psychiatric disorders preventing understanding or compliance.
• Any condition that, in the investigator's judgment, makes participation unsuitable.

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Condition: Prostate Carcinoma

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT07645391

Sponsor: University of Michigan Rogel Cancer Center

Phase:

Eligibility:

• Age: minimum 35 Years maximum 70 Years
• Gender: Male

Inclusion Criteria:

• * Age 35-70 years
• Capable of providing informed consent
• Prognosis of > 5 years if affected by another cancer
• Patients need one to meet at least one of the following high genetic risk categories:
• Known PCa-related mutations: BRCA 1 and 2, Lynch syndrome, or p53
• Carrier of mutation in a suspected PCa-related gene: e.g., ATM, PALB2, CHEK2, RAD51D, ATR, NBN, GEN1, RAD51C, MRE11A, BRIP1, FAM175A, HOXB13
• Obligate carriers of the above mutations (e.g. their sisters/daughters have known mutations)
• Men with any family history of above mutation
• Family history of breast, prostate, or ovarian cancer in at least 2 individuals, or in 1 individual diagnosed before age 50

Exclusion Criteria:

• * Anuria
• Prior diagnosis or treatment for PCa
• Failure to provide informed consent
• Life expectancy < 5 years

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Condition: Advanced Prostate Cancer, Metastatic Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07567846

Sponsor: Genentech, Inc.

Phase: Phase 1/Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) Performance Status of <=1
• Life expectancy is >= 3 months
• Histologically or cytologically confirmed prostate adenocarcinoma
• Disease progression during or following the direct prior line of therapy
• Ongoing androgen deprivation therapy (ADT) with gonadotropin-releasing hormone (GnRH) agonist or antagonist, or have had bilateral orchiectomy
• Metastatic disease
• Adequate end organ function

Exclusion Criteria:

• Treatment with any approved systemic anti-cancer therapy within 14 days or 5 drug elimination half-lives
• Structurally unstable bone lesions suggest an impending fracture
• Untreated central nervous system (CNS) metastases or leptomeningeal disease
• Uncontrolled pain
• History of malignancy within 5 years
• Infection requiring systemic IV antibiotics within 14 days or oral antibiotics within 7 days prior to screening, or any evidence of current infection
• Any medical condition or abnormal clinical laboratory finding that, in the investigator's judgment, would preclude the individual's safe participation in and completion of the study or could affect the interpretation of the results

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Condition: Urologic Neoplasms, Benign Prostatic Hyperplasia, Anesthesia

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07643415

Sponsor: Hitit University

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Male patients aged 18 years or older.
• Diagnosis of benign prostatic hyperplasia (BPH).
• Scheduled to undergo open simple prostatectomy.
• American Society of Anesthesiologists (ASA) physical status I-III.
• Ability to provide written informed consent.

Exclusion Criteria:

• Refusal or inability to provide informed consent.
• Patients scheduled for radical prostatectomy due to prostate cancer.
• Emergency surgery.
• Known coagulation disorders or clinically significant thrombocytopenia.
• Ongoing anticoagulant or antiplatelet therapy that cannot be discontinued according to institutional protocols.
• Contraindication to spinal anesthesia.
• Participation in another interventional clinical trial that may affect study outcomes.
• Administration of tranexamic acid or any additional hemostatic agent during the perioperative period.

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Condition: Prostate Cancer, Adaptive Radiotherapy, Quality of Life

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT06355050

Sponsor: Jena University Hospital

Phase:

Eligibility:

• Age: minimum 18 Years maximum 120 Years
• Gender: Male

Inclusion Criteria:

• no androgen deprivation therapy within the last 2 months prior to RT
• good performance status (Eastern Cooperative Oncology Group, ECOG, 0/1)
• no secondary malignancy

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Condition: Metastatic Castration-resistant Prostate Cancer, Advanced Prostate Adenocarcinoma, PSCA-positive Prostate Cancer, PSMA-Positive Progressive Metastatic Castration-Resistant Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07641049

Sponsor: Beijing Biotech

Phase: Phase 1

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Male participant age 18 years or older.
• Histologically or cytologically confirmed prostate adenocarcinoma with metastatic castration-resistant disease.
• Disease progression by PCWG3 while maintaining castrate testosterone (<50 ng/dL) with ongoing androgen deprivation therapy or prior orchiectomy.
• Documented PSMA and/or PSCA expression by a validated tumor assay; PSMA PET may support target confirmation when applicable.
• Prior progression on at least one androgen receptor pathway inhibitor such as abiraterone, enzalutamide, apalutamide, or darolutamide; prior taxane, PARP inhibitor, radioligand therapy, or checkpoint inhibitor is allowed.
• ECOG performance status 0 or 1.
• Adequate hematologic, renal, hepatic, cardiac, and pulmonary function per protocol laboratory thresholds.
• At least one measurable lesion by RECIST 1.1 or evaluable bone-predominant disease by PCWG3.
• Life expectancy of at least 12 weeks.
• Ability to understand and sign informed consent and willingness to provide required blood and tissue samples.

Exclusion Criteria:

• Active central nervous system metastases or leptomeningeal disease.
• Dominant small-cell or neuroendocrine prostate cancer histology.
• Prior gene-modified cellular therapy within 6 months before lymphodepletion, or prior allogeneic transplant requiring ongoing systemic immunosuppression.
• Active autoimmune disease requiring systemic treatment or chronic immunosuppression; systemic corticosteroid use greater than 10 mg prednisone equivalent daily within 7 days of lymphodepletion.
• Uncontrolled infection, including uncontrolled hepatitis B, hepatitis C, or HIV infection.
• Clinically significant cardiovascular disease, symptomatic arrhythmia, recent myocardial infarction, or uncontrolled heart failure.
• Unresolved grade 2 or higher toxicity from prior anticancer therapy, except alopecia, stable endocrinopathy, or other protocol-approved exceptions.
• Another active malignancy requiring systemic treatment.
• Any medical, psychiatric, or laboratory abnormality that, in the investigator's judgment, would increase risk or interfere with study interpretation.

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Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07600554

Sponsor: Philogen S.p.A.

Phase: Phase 1

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• 1. Prostate cancer patients with:
• suspected metastasis who are candidates for initial definitive therapy
• suspected recurrence based on elevated serum prostate-specific antigen (PSA) level (i.e., a progressive and confirmed serum PSA level > 0.2 ng/mL)
• metastatic disease who might be candidates for treatment with 177Lu-labelled PSMA ligands. (Note: patients with a negative PSMA-PET/CT or discordant PSMA-PET and FDG-PET findings are eligible for this study, providing that they have a histologically confirmed diagnosis of prostate cancer) 2. Subjects able to father children must agree to practice effective contraception for three months starting from the study drug administration. 3. Age ≥ 18 4. ECOG ≤ 1 5. Patient must not have any concomitant infections or active concomitant disease. 6. All acute toxic effects (excluding alopecia and fatigue) of any prior therapy (including surgery, radiation therapy, chemotherapy) must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v. 6.0) Grade ≤ 1. 7. Life expectancy of more than 12 weeks. 8. Ability to undergo imaging study procedures. 9. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. 10. Willingness and ability to comply with the scheduled visits, plan, laboratory tests and other study procedures. Exclusion Criteria: 1. Chronically impaired renal function as expressed by creatinine clearance < 60 mL/min or serum creatinine > 1.5 x ULN. Note: it is sufficient to evaluate either creatinine clearance or serum creatinine 2. Presence of active hepatitis. 3. Presence of significant cardiac disorders (congestive heart failure, NYHA class III-IV, myocardial infarction within one year prior to study entry, uncontrolled hypertension, or arrhythmia). 4. Any concomitant condition which in the opinion of investigators makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol. 5. Major trauma including major surgery (such as abdominal/cardiac/thoracic surgery) within 4 weeks of administration of the study drug. Minimally invasive procedures such as biopsies are not considered as

Exclusion Criteria:

1. Chronically impaired renal function as expressed by creatinine clearance < 60 mL/min or serum creatinine > 1.5 x ULN. Note: it is sufficient to evaluate either creatinine clearance or serum creatinine
2. Presence of active hepatitis.
3. Presence of significant cardiac disorders (congestive heart failure, NYHA class III-IV, myocardial infarction within one year prior to study entry, uncontrolled hypertension, or arrhythmia).
4. Any concomitant condition which in the opinion of investigators makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol.
5. Major trauma including major surgery (such as abdominal/cardiac/thoracic surgery) within 4 weeks of administration of the study drug. Minimally invasive procedures such as biopsies are not considered as exclusion criteria.
6. Serious, non-healing wound, ulcer, or bone fracture.
7. Allergy to study medication or excipients in study medication.
8. Any anti-cancer therapy (e.g., cytotoxic chemotherapy, immunotherapy, radiation, surgery, etc.) within 3 weeks before [68Ga]Ga-OncoACP3-PET/CT scan.
9. Subject has received, or is scheduled to receive, another investigational medicinal product (IMP) from one month before [68Ga]Ga-OncoACP3 injection to end of study participation.

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Condition: Metastatic Breast Cancer, Metastatic Prostate Cancer, GRPR-Targeted Molecular Imaging, Theranostic Radiopharmaceuticals, Cancer, Active Cancer, Theranostic, Radiopharmaceutical

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07608848

Sponsor: Integrated Haematology and Oncology Network

Phase: Early Phase 1

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

1. Inclusion criteria refer to the enrolment of participants for the PET/CT and SPECT/CT imaging with the radioligands; PET imaging tracer [68Ga]Ga-DOTA-STR-17126 and with the SPECT imaging tracer [177Lu]Lu-DOTA-STR-171
2. Participants must meet all of the following inclusion criteria to be eligible for enrolment.
3. Ability to understand and willingness to provide informed consent
4. Adults ≥ 18 years of age
5. Must have the following histologically or cytologically confirmed diagnosis of advanced or metastatic i. breast cancer ii. prostate cancer
6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
7. Participant must have clinical or radiological documented tumour progression as established by the Investigator within 30 days of signing consent for the study
8. Participants who have exhausted standard-of-care systemic therapies in their metastatic setting. At least one detectable by conventional imaging tumour lesion with any diameter of ≥ 1 cm in size
9. Participants must have adequate organ and bone marrow function, defined as follows: i. Absolute neutrophil count (ANC) ≥ 1000 cells/mm3 ii. Platelet count ≥ 100,000/mm3 iii. Haemoglobin ≥ 9.0 g/dL iv. AST, ALT, alkaline phosphatase ≤ 3 times upper limit of normal (ULN) if there is no evidence of liver metastases or ≤5 ULN in the presence of liver metastases v. Total bilirubin ≤ 2 times upper limit of normal (ULN) vi. Creatinine ≤ 2 times ULN and creatinine clearance (CrCL) ≥ 60mL/min using the Cockcroft Gault equation (Appendix 2)
10. Able to remain still for up to 60 minutes per scan
11. Any other condition which, in the opinion of the Investigator, would preclude participation in this study Optional: Participants that have available archival tissue (at least 15 consecutive, unstained, formalin-fixed, paraffin embedded (FFPE) slides or 1 FFPE block), or a fresh tumour biopsy sample that opt to provide samples will be used for GRPR analysis (histology staining or RNA measurements). Participants without any archival tissue or fresh biopsy sample, or who refuse to provide archival tissue are still eligible for the study. Exclusion Criteria: Participants must not be enrolled into the trial if one or more of the following criteria are met. Participants must NOT meet any of the following

Exclusion Criteria:

1. Participants must not be enrolled into the trial if one or more of the following criteria are met. Participants must NOT meet any of the following Exclusion criteria to be eligible for enrolment:
2. Known hypersensitivity to the investigational medicinal products (DOTA-STR-17126) or any of the excipients.
3. Participants with Class 3 or 4 New York Heart Association (NYHA) Congestive Heart Failure.
4. Average QTc (using the Fridericia correction calculation) > 470 msec for females and QTcF >450 msec for males on screening ECG or history of congenital long QT syndrome.
5. Clinically significant bleeding within two weeks prior to trial entry (i.e., gastrointestinal bleeding, intracranial bleeding).
6. Pregnant or lactating women. i. For female participants of childbearing potential or male participants with female partner of childbearing potential, who are not willing to practice highly effective contraception during the trial and for at least 6 months after [177Lu] Lu-DOTA-STR-17126 administration ii. Sexually active males must use a condom during intercourse while taking the drug and for 4 months after stopping treatment and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid. Female partners of childbearing potential should use highly effective contraceptive methods during and up to 6 months after stopping treatment.
7. Have any medical condition that impairs complete bladder emptying. Participants with permanent urinary indwelling catheter (IDC) or nephrostomy may be allowed to enrol on a case-by-case basis in discussion with Principal Investigator, if it is determined not to put the patient at an increased risk of adverse drug effects and/or interfere with the integrity of study outcome.
8. Major surgery, defined as any surgical procedure that involves general anaesthesia and a significant incision (i.e., larger than what is required for placement of a central venous access, percutaneous feeding tube, or biopsy) within 30 days before study day 1 or anticipated surgery within the subsequent 43 days (6 weeks).
9. Has an additional active malignancy requiring therapy within the past 2 years.
10. History of another malignancy within 3 years before study enrolment. A subject with the following malignancies is allowed if considered cured or unlikely to recur within 3 years: i. Carcinoma of the skin without melanomatous features ii. Curatively treated cervical carcinoma in situ iii. Bladder tumours considered superficial such as non-invasive (T1a) and carcinoma in situ (T1s), thyroid papillary cancer with prior treatment
11. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy within 30 days prior to trial enrolment.
12. Psychiatric illness/social situations that would interfere with compliance with study requirements.
13. Cannot undergo PET/CT scanning because of weight limits (350 lbs or 160 kg).
14. Prior exposure to any other GRPR-targeting therapeutic agents.
15. Prior treatment with any systemic anti-cancer therapy including chemotherapy, immunotherapy, biological therapy, radiation therapy, biologic, hormonal or herbal therapy, or any investigational therapy or investigational device, unless: i. Standard of care or maintenance therapy such as, luteinizing hormone-releasing hormone (LHRH) or gonadotropin releasing hormone (GnRH) for patients with prostate cancer; selective estrogen receptor modulators or aromatase inhibitors or GnRH inhibitors for breast cancer, ii. Within more than 30 days of chemotherapy, herbal therapies and monoclonal antibodies, iii. Within more than 5 half-lives for biologic/non-cytotoxic targeted agents, iv. Within more than 8 weeks prior radiation therapies External Beam Radiotherapy (EBRT) and/or Radioligand Therapy (RLT). Focal palliative radiotherapy given within 8 weeks prior to the low dose of [177Lu] Lu-DOTA-STR-17126 may be approved on a case-by-case basis, if it is determined not to put the participant at an increased risk of adverse drug effects and/or interfere with the integrity of study outcome, v. For participants who received radiotherapy (EBRT and/or RLT) more than 8 weeks prior to the low dose of 177Lu-DOTA-STR-17126, efforts should be made to calculate the prior radiation absorbed dose to each critical organ such as the kidneys, liver, lungs, and bone marrow.
16. Patients with a history of inflammatory disease which according to the investigator may interfere with correct evaluation of radioactive uptake, especially those affecting the thoraco-abdominal cavities (i.e., autoimmune, granulomatous disease).
17. Any clinically significant toxicity (with the exception of alopecia) related to prior anti-tumour therapy not resolved to Grade 1 or baseline.

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Condition: Prostate Cancer, Surgery, Fluid Overload, Lactate Blood Increase

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07626151

Sponsor: Nazmy Edward Seif

Eligibility:

• Age: minimum 40 Years maximum 80 Years
• Gender: Male

Inclusion Criteria:

• Male patient undergoing robotic assisted prostatectomy
• ASA I-III

Exclusion Criteria:

• ASA score more than III
• BMI more than 40
• Severe renal disease (GFR between 15 and 29)
• Previous renal surgery.
• Decompensated cardiac disease (NYHA class 3 or 4)

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Condition: Prostate Cancer, Prostate Adenocarcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07635238

Sponsor: Memorial Sloan Kettering Cancer Center

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Documentation of Disease o Patients must have pathologically confirmed prostate adenocarcinoma.
• Definition of Disease
• Grade Group (GG) 1, 2, or 3.
• PSA less than 20 ng/mL prior to starting ADT, if used.
• Clinical stage of TX, T1 or T2 on digital rectal examination. May have up to radiological stage T3a on MRI. MRI must be performed within 12 months of randomization.
• MRI-visible tumor(s), all having PIRADS v2 scores of 3, 4, or 5. Each tumor should be able to be delineated on T2 and diffusion-weighted imaging (DWI) +/- dynamic contrast-enhanced imaging (DCE).
• Tumor nodule visible on MRI should be considered able to be boosted by treating clinician (ie meet urethral constraints while maintaining mandatory GTV coverage) and <2.5cm in maximal dimension.
• The MRI-defined lesion must be confirmed as malignant on biopsies (Grade group 1, 2, or 3).
• Patients can be concurrently treated with androgen deprivation therapy (ADT) if this would be standard of care. LHRH analogues, LHRH agonists or Bicalutamide are permitted. ADT is not mandatory where this would usually be omitted. Patients needing greater than 6 months of ADT due to disease parameters should be excluded.
• No high grade disease (GG3) occult to MRI-defined lesion. As a guide, any pathology for which you would consider surveillance (e.g. GG1, low volume GG2) is allowed outside of the MRI-defined area.
• No contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia).
• Prostate volume less than or equal to 90mL.
• No evidence of nodal or distant metastatic disease.
• Prior Treatment o No history of previous radiation to the prostate, prostate surgery (including transurethral resection of the prostate (TURP)), or other local prostate cancer treatments.
• Age ≥ 18
• ECOG Performance Status of ≤ 2 (See Appendix I for performance status criteria)
• Required Organ Function
• Adequate hematologic function defined as follows:
• Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
• Platelets ≥ 100,000 cells/mm3
• Hemoglobin ≥ 8 g/dl
• Adequate renal function defined as follows:
• Creatinine clearance (CrCL) of ≥30 mL/min by the Cockcroft-Gault formula: CrCl (mL/min) = [140
• age (years)] x weight (kg) / 72 x creatinine (mg / dL) {x 0.85 for female patients}
• Adequate hepatic function defined as follows:
• Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x ULN may be enrolled)
• AST and ALT ≤3 x institutional ULN
• Adequate cardiac function defined as follows:
• Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.
• To be eligible for this trial, patients should be class 2B or better (see Appendix II: New York Heart Association (NYHA) Functional Classification).
• Comorbid Conditions
• No active infection requiring parenteral antibiotic(s).
• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
• No severe GU symptoms that would preclude extreme hypofractionation per the discretion of the treating physician.
• No IPSS Score greater than 19.
• No comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up.
• Ability of the participant to understand and the willingness to sign a written informed consent form.
• Willing to consent to contraception during and for 1 year after treatment when applicable.
• Ability/willingness to comply with the patient reported outcome questionnaires schedule throughout the study.

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