[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-prostate-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-prostate-adenocarcinoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,52,81],{"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":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100641941","phase-2-study-of-psma-targeted-therapy-and-androgen-receptor-suppression-in-low-volume-metastatic-prostate-cancer-sparkle-trial-100641941",false,"NCT07650240","Study of PSMA-targeted Therapy and Androgen Receptor Suppression in Low-volume Metastatic ProstatE Cancer: SPARKLE Trial","A Phase II Randomized Trial of Intermittent Androgen Deprivation Therapy Alone or Combined With [177Lu]Lu-PSMA-617, With or Without Abiraterone and Prednisone, in Patients With Low-Volume Metastatic Hormone-Sensitive Prostate Cancer","SPARKLE","Inclusion Criteria:\n\n* Male patients aged 18 years or older\n* Signed informed consent must be obtained prior to participation in the study\n* Histologically confirmed adenocarcinoma of the prostate\n* Prior treatment with radical prostatectomy or radiation therapy for localized disease is required\n* Prior treatment with ADT or androgen receptor pathway inhibitor (ARPI) or cytotoxic chemotherapy is permitted if:\n\n  * The last treatment \\> 12 months from enrollment on the trial\n  * The duration of treatment is less than 3 months and no evidence of disease progression on treatment\n* Disease detected on PSMA PET\u002FCT scan \\[PSMA-avid low volume metastasis (LVM)\\]. Patients with standardized uptake value maximum (SUVMax) lesion\u002Fliver \\>1 \\[molecular imaging PSMA (miPSMA) score of 2\\] or lesion\u002Fparotid \\> 1 (miPSMA score of 3) would be included. PET scanners used in the study will comply with current guidelines established by the European Association of Nuclear Medicine (EANM) Research Limited (Ltd) (EARL) for harmonizing PET\u002FCT image acquisition and reconstruction\n* Patients with hormone sensitive low volume metastatic disease (LVM); either de novo metastatic or recurrent disease. LVM, as assessed on PSMA PET\u002FCT is defined as:\n\n  * =\\\u003C 10 total metastatic spots\n\n    * Lymph nodes with short axis of =\\\u003C 2.5 cm\n    * Total tumor volume (TTV) \\\u003C 200 mL\n  * =\\\u003C 4 bone metastases\n  * No brain or liver metastases\n* Eastern Cooperative Oncology Group (ECOG) performance 0 - 2\n* Hemoglobin \\>= 9 g\u002FdL\n* Platelet count \\>= 100,000\u002Fmm\\^3\n* Absolute neutrophil count \\>= 1,500\u002Fmm\\^3\n* Serum bilirubin =\\\u003C 1.5 x upper limit of normal (ULN)\n* Alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) =\\\u003C 2.5 x ULN\n* Serum creatinine =\\\u003C 1.5 x ULN or an estimated glomerular filtration rate (eGFR) \\>= 50 mL\u002Fmin\u002F1.73m\\^2\n* Able to start therapy within 28 days of screening\n* Expected life expectancy \\> 6 months\n\nExclusion Criteria:\n\n* PSMA-undetectable disease defined as rising prostate specific antigen (PSA) with absence of PSMA-positive lesions in PSMA PET\u002FCT imaging\n* PSMA-negative disease defined as lesions detected on imaging that are deemed concerning for active cancer metastasis with PSMA SUVmax less than liver and meeting specific size criteria: lymph nodes with short axis of \\>= 2.5 cm, visceral lesions with a solid appearance (soft tissue density) \\>= 1 cm, and bone metastases with a measurable soft tissue component \\>= 1 cm\n* Patient with in-field failure (disease recurrence in prostate bed after primary definitive prostatectomy or radiotherapy)\n* Patient with spinal metastatic disease-causing cord compression\n* Patient with prior disease progression on ADT \\[castration resistance prostate cancer (CRPC)\\]\n* Prior treatment with ADT or cytotoxic chemotherapy or ARPI within less than 12 months from enrollment on the trial\n* Prior treatment with ADT or ARPI or cytotoxic chemotherapy is permitted only if more than 3 months treatment duration and no evidence of disease progression on treatment\n* Patients with severe \\[Common Terminology Criteria for Adverse Events (CTCAE) grade \\> 2\\] xerostomia\n* Patients with well documented history of myelosuppression or renal disease that might impair their participation in the trial per medical advice\n* Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated non-melanoma skin cancer, superficial bladder cancer are eligible\n* Estimated life expectancy \\\u003C 6 months\n* Concurrent serious medical co-morbidities as determined by study investigator and expected to impair participation in the study\n\n  * Subjects with female partners of reproductive potential are required to use effective, medically acceptable methods of birth control (e.g., spermicide in conjunction with a barrier such as a condom or sexual abstinence) while on this study, and for 14 weeks after the last dose of 177Lu-PSMA-617","MALE","18 Years",{"count":20,"type":21},202,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This phase II trial tests leuprolide acetate alone versus in combination with 177Lu-PSMA-617, with or without abiraterone acetate and prednisone, for the treatment of hormone-sensitive prostate cancer has spread to a limited number of anatomic sites at the time of initial diagnosis (de novo low volume metastasis) or that has come back after a period of improvement (recurrent). Standard of care treatment for prostate cancer usually includes androgen deprivation therapy, with or without abiraterone acetate and prednisone. Leuprolide acetate is a form of androgen deprivation therapy. It blocks the body from making testosterone (a male hormone) and estradiol (a female hormone). It may stop the growth of prostate cancer cells that need testosterone to grow. 177Lu-PSMA-617 is a type of radioconjugate drug. Upon administration, vipivotide tetraxetan targets and binds to prostate specific membrane antigen (PSMA)-expressing tumor cells. Upon binding, PSMA-expressing tumor cells are destroyed by 177Lu through the specific delivery of radiation. PSMA, a tumor-associated antigen and type II transmembrane protein, is overexpressed on prostate tumor cells. Abiraterone acetate is a type of anti-androgen drug. It blocks tissues from making androgens (male hormones), such as testosterone. This may cause the death of cancer cells that need androgens to grow. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving 177Lu-PSMA-617 in combination with leuprolide acetate, with or without abiraterone acetate and prednisone, may be more effective at treating patients with recurrent or de novo low volume metastatic hormone-sensitive prostate cancer than giving leuprolide acetate alone.",[27,28,29,30,31,32,33,34,35,36,37,38],"Recurrent Prostate Adenocarcinoma","Stage IVB Prostate Cancer AJCC v8","Castration-Sensitive Prostate Cancer","Metastatic Hormone-sensitive Prostate Cancer (mHSPC)","Prostate Cancer","Prostate Adenocarcinoma","Adenocarcinoma of the Prostate","Localized Prostate Carcinoma","Metastatic Prostate Cancer","Metastatic Prostate Adenocarcinoma","Advanced Prostate Cancer","Advanced Prostate Adenocarcinoma","NOT_YET_RECRUITING","2026-06-15",{"date":42,"type":43},"2026-06-17","ACTUAL",{"date":45,"type":21},"2026-07-01",{"date":47,"type":21},"2030-12-30",{"name":49,"class":50},"Mayo Clinic","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},"100531862","phase-3-sbrt-versus-hypofractionated-radiotherapy-for-biochemically-recurrent-or-oligometastatic-prostate-adenocarcinoma-100531862","NCT06205316","SBRT Versus Hypofractionated Radiotherapy for Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma","Randomized Phase III Trial of SBRT Versus Hypofractionated Radiotherapy for Salvage of Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma After Radical Prostatectomy","Inclusion Criteria:\n\n* Histologically confirmed prostate adenocarcinoma at the time of surgery\n* Pathologic stages T2-T3b, Nx or N0-1, M0-1 as staged by the pathology report (American Joint Committee on Cancer \\[AJCC\\] Criteria 8th edition \\[Ed.\\])\n* PSA post radical prostatectomy ≥ 0.1 and \\\u003C 2.0 ng\u002FmL ≤ 90 days prior to enrollment, obtained ≥ 6 weeks after surgery\n* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 assessed ≤ 90 days of enrollment\n* Patients must sign institutional review board (IRB) approved study specific informed consent\n* Patients must complete all required pre-entry tests within the specified time frames\n* Patients must be able to start treatment (ADT or radiation) ≤ 120 days of study registration\n* Patients must be ≥ 18 years old\n* Prostate cancer up to oligometastatic disease, up to 5 sites\n\nExclusion Criteria:\n\n* Previous pelvic radiation\n* Prior androgen deprivation therapy for prostate cancer and PSA ≥ 0.1 ng\u002FmL\n* Active rectal diverticulitis, Crohn's disease affecting the rectum, or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed)\n* Prior systemic chemotherapy for prostate cancer\n* History of proximal urethral stricture requiring dilatation\n* Major medical, addictive, or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and\u002For interfere with follow-up. (Consent by legal authorized representative is not permitted for this study)\n* History of myocardial infarction or decompensated congestive heart failure (CHF) within the last 6 months\n* On a transplant list\n* More than oligometastatic disease \\> 5 metastatic sites",{"count":60,"type":21},118,[62],"PHASE3","This phase III trial tests the side effects of stereotactic body radiation therapy (SBRT) compared to hypofractionated radiotherapy for treating patients with prostate adenocarcinoma that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to a limited number of sites (oligometastatic). SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumors cells and have fewer side effects. SBRT may work just as well as hypofractionated radiation therapy at treating patients with biochemically recurrent or oligometastatic prostate cancer, but with a shorter treatment time and possibly fewer side effects.",[65,66,27,67,68,69,70],"Biochemically Recurrent Prostate Carcinoma","Oligometastatic Prostate Carcinoma","Stage IIB Prostate Cancer AJCC v8","Stage IIC Prostate Cancer AJCC v8","Stage III Prostate Cancer AJCC v8","Stage IV Prostate Cancer AJCC v8","RECRUITING","2026-01-16",{"date":74,"type":43},"2026-01-20",{"date":76,"type":43},"2024-01-22",{"date":78,"type":21},"2030-01-22",{"name":49,"class":50},6,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":51},"100604530","phase-2-alpha-emitting-radionuclide-or-beta-emitting-radionuclide-with-metastasis-directed-stereotactic-body-radiotherapy-for-the-treatment-of-recurrent-oligometastatic-prostate-adenocarcinoma-100604530","NCT07150715","Alpha-Emitting Radionuclide or Beta-Emitting Radionuclide With Metastasis-Directed Stereotactic Body Radiotherapy for the Treatment of Recurrent, Oligometastatic Prostate Adenocarcinoma","Alpha-Emitting Radionuclide or Beta-Emitting Radionuclide Combined With Metastasis-Directed Stereotactic Body Radiotherapy for Oligorecurrent Prostate Adenocarcinoma (ANDROMEDA)","ANDROMEDA","Inclusion Criteria:\n\n* Oligorecurrent prostate cancer as determined by the presence of 1-5 asymptomatic lesions outside the prostate or prostate bed identified on PSMA PET\u002FCT by local readers\n* Serum testosterone \\> 150 ng\u002FdL\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* No indication for urgent or emergent radiation\n* Histological confirmation of prostate adenocarcinoma (histology from original treatment acceptable)\n* White blood cell count ≥ 2.5 × 109\u002FL\n* Platelets ≥ 100 × 109\u002FL\n* Hemoglobin ≥ 9 g\u002FdL\n* Total bilirubin ≤ 1.5 × institutional upper limits of normal (ULN) or up to 3 × ULN if known history of Gilbert's syndrome\n* Alanine aminotransferase or aspartate aminotransferase ≤ 3.0 × ULN or ≤ 5.0 × ULN for patients with liver metastases\n* Glomerular filtration rate creatinine-cystatin C (GFRcr-cys) ≥ 60 mL\u002Fmin 1.73m2 using the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) 2021 equation\n* Serum albumin \\> 3.0 g\u002FdL\n* Partner and patient must use a method of birth control with adequate barrier protection, deemed acceptable by the principal investigator during the study and for 3 months after last study drug administration\n* Ability to understand, and willingness to sign, the written informed consent\n\nExclusion Criteria:\n\n* Patients with neuroendocrine or small cell carcinoma of the prostate\n* Patients with castrate-resistant disease (i.e., prostate specific antigen \\[PSA\\] \\> 0.5 ng\u002FmL with serum testosterone \\\u003C150 ng\u002FdL)\n* Patients who received androgen deprivation therapy or cytotoxic chemotherapy within 6 months of trial enrolment\n* Concurrent systemic therapy for a solid organ malignancy\n* Spinal cord compression\n* Inability to lie flat\n* Known hypersensitivity to components of 177-Lu-PSMA-617 or 225-Ac-Lu-PSMA-617\n* Inadequate renal function of GFRcr-cys \\\u003C 60 mL\u002Fmin 1.73m2 using the CKD-EPI 2021equation\n* Total bilirubin \\> 1.5 × ULN or \\> 3.0 × ULN if known history of Gilbert's syndrome\n* Alanine aminotransferase or aspartate aminotransferase \\> 3 × ULN (or 5 × ULN for patients with known liver metastases)\n* De novo oligometastatic disease",{"count":90,"type":21},107,[24],"This phase II trial compares the use of 225Ac-PSMA-617 to 177Lu-PSMA-617, along with stereotactic body radiotherapy for the treatment of prostate cancer that has come back after a period of improvement (recurrent) and that has spread from where it first started (primary site) to multiple other places in the body (oligometastatic). 225Ac-PSMA-617 and 177Lu-PSMA-617 are radioactive drugs. They bind to a protein called a PSMA receptor, which is found on some prostate tumor cells. 225Ac-PSMA-617 or 177Lu-PSMA-617 builds up in these cells and gives off either alpha or beta radiation that may kill them. It is a type of radioconjugate and a type of PSMA analog. Stereotactic body radiation therapy (SBRT) is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Giving 225Ac-PSMA-617 or 177Lu-PSMA-617 and metastasis directed stereotactic body radiotherapy may be effective in treating patients with recurrent, oligometastatic prostate cancer.",[94,27],"Oligometastatic Prostate Adenocarcinoma","2025-12-15",{"date":97,"type":43},"2025-12-17",{"date":99,"type":43},"2025-12-12",{"date":101,"type":21},"2031-10-31",{"name":103,"class":50},"Jonsson Comprehensive Cancer Center"]