[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"oligometastatic-prostate-cancer-ompc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:oligometastatic-prostate-cancer-ompc":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,52,82],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100511436","phase-3-an-open-label-study-comparing-lutetium-177lu-vipivotide-tetraxetan-versus-observation-in-psma-positive-ompc-100511436",false,"NCT05939414","An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.","An International, Prospective, Open-label, Multi-center, Randomized Phase III Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) Versus Observation to Delay Castration or Disease Recurrence in Adult Male Patients With Prostate-specific Membrane Antigen (PSMA) Positive Oligometastatic Prostate Cancer (OMPC)","PSMA-DC","Key Inclusion criteria:\n\n1. Histologically confirmed prostate cancer prior to randomization\n2. Participants must have biochemically recurrent disease after definitive treatment to prostate by Radical Prostatectomy ((RP), (alone or with post-operative radiation to prostate bed\u002Fpelvic nodes)) or External beam Radiation Therapy (EBRT), (prostate alone or prostate with seminal vesicle and\u002For pelvic nodes) and\u002For brachytherapy prior to randomization. Biochemical recurrence (BCR) is defined as: nadir PSA + 2 ng\u002FmL post XRT (if participant received-radiation therapy to intact prostate) and PSA \\> 0.2 ng\u002FmL and rising post RP (with or without post-operation Radiation Therapy (RT))\n3. Participants must have OMPC with 1-5 PSMA -positive metastatic lesions on screening PSMA PET\u002FCT scan (with either gallium (68Ga) gozetotide or piflufolastat (18F)) as visually assessed by BIRC. For definition of PSMA PET positivity, please refer to Section 8.1 and the Imaging Manual. Metastatic lesions may include regional\u002Fpelvic lymph nodes (N1), distant lymph nodes (M1a), bone (M1b), lung and others visceral (M1c) except liver and brain classified using American Joint Committee on Cancer (AJCC) 8. When counting the number of oligometastatic lesions, each lesion is counted as distinct metastasis irrespective of its anatomical location (e.g., one pelvic and one extra-pelvic lymph node will be counted as two metastatic lesions)\n4. At least 1 PSMA-positive lesion must be a distant metastasis (M1) per AJCC8 classification at screening. For AJCC M staging, PSMA PET\u002FCT information should be used\n5. Participants must have a negative CI for M1 disease at screening.\n\n   Note:\n   * For a participant not to be eligible, CI positive M1 lesions should be unequivocal in CI scans, i.e., potentially not attributable to findings thought to represent something other than tumor (e.g., degenerative, or post-traumatic changes or Paget's disease in bone lesions). For CI assessments, bone lesions must be assessed by bone scan only and soft tissue lesions must be assessed by CT\u002FMRI scans only at screening.\n   * Prior knowledge of PSMA PET positivity should not influence the radiologist (reader) in determination of CI positivity. Two different readers will be involved, one reader for PSMA PET\u002FCT scan and one reader for CI: Reader will be blinded to PSMA PET scan results while reading CI scans. Reader should not modify their assessment of CI scans (e.g. changing a lesion previously identified as equivocal in CI to unequivocal) after reading the PSMA PET scan. Similarly, biopsy positivity should not influence the reader in the assessment of CI positivity. More details on the reading paradigm will be provided in the imaging charter\n   * MRI for radiation treatment planning may show M1 disease but this will not exclude the participant from the study if the lesion is deemed negative per baseline CT or bone scans\n   * Participants with pelvic disease (N1) seen in CI are allowed if the local spread is below common iliac bifurcation (per AJCC 8 definition of local disease)\n   * Distant lymph node disease (M1a) that is visible per CI and less than 10mm in the short axis is not exclusionary irrespective of PSMA PET positivity.\n   * If a previously surgically removed lesion was unequivocal for M1 by bone scan or CT, the participant is not eligible.\n6. All metastatic lesions detected at screening must be amenable to SBRT\n7. Non-castration testosterone level \\>100 ng\u002FdL at screening\n\nKey Exclusion criteria:\n\n1. Participants with de novo OMPC at screening\n2. Unmanageable concurrent bladder outflow obstruction or urinary incontinence at screening. Note: participants with bladder outflow obstruction or urinary incontinence, which is manageable and controlled with best available standard of care (incl. pads, drainage) are allowed\n3. Prior therapy with:\n\n   1. ADT (including bilateral orchiectomy) and ARPIs used for metastatic prostate cancer treatment\n\n      * Participants who received AR-directed therapy, whether ADT or an ARPI or both, as neoadjuvant or adjuvant therapy as a component of their primary therapy, are eligible provided that they discontinued therapy ≥12 months prior to randomization for ADT (i.e., 12 months after the last day of the last injection) or ≥3 months if ARPI was given as monotherapy. ARPI's as a term includes both contemporary androgen synthesis inhibitors (e.g., abiraterone, galeterone, and orteneronel), and receptor inhibitors (enzalutamide, apalutamide and darolutamide).\n      * Patients who biochemically relapsed after primary therapy may also have had treatment with AR directed therapy and participants who had SBRT with ADT are also eligible provided that the ARPI +\u002F- ADT or ADT alone was terminated\n\n        ≥12 months prior to randomization for ADT (i.e., 12 months after the last day of the last injection) or ≥3 months if ARPI was given as monotherapy.\n      * Participants who received first generation anti-androgens (bicalutamide, flutamide, nilutamide, cyproterone) for biochemical recurrence or adjuvant\u002Fneoadjuvant therapy are eligible provided that they discontinued therapy ≥3 months prior to randomization.\n      * Participants who have discontinued ADT due to disease progression are not eligible (i.e., Castration-Resistant Prostate Cancer (CRPC) participants)\n   2. Other hormonal therapy. e.g.,\n\n      •Use of estrogens, 5-α reductase inhibitors (finasteride, dutasteride), other steroidogenesis inhibitors (aminoglutethimide) if used in the context of prostate cancer treatment. Same medications are allowed if used for other indications: e.g., Benign Prostatic Hyperplasia (BPH), if stopped ≥3 months before randomization.\n   3. Radiopharmaceutical agents (e.g., Strontium-89, PSMA-targeted radioligand therapy)\n   4. Immunotherapy (e.g., sipuleucel-T)\n   5. Chemotherapy, except if administered in the adjuvant\u002Fneoadjuvant setting completed \\> 12 months before randomization\n   6. Any other investigational or systemic agents for metastatic disease\n4. Radiation therapy external beam radiation therapy (EBRT) and brachytherapy within 28 days before randomization\n5. Concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, hormonal therapy (see ADT initiation guidance in Section 6.8.2), Poly Adenosine Diphosphate-Ribose Polymerase (PARP) inhibitor, biological therapy or investigational therapy\n6. Diagnosed at screening 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 and who have been disease\u002Ftreatment free for more than 3 years are eligible, as are participants with adequately treated non-melanoma skin cancer and superficial bladder cancer.\n7. History or current diagnosis of ECG abnormalities indicating significant risk of safety for participants participating in the study such as:\n\n   * Concomitant clinically significant cardiac arrhythmias, e.g. sustained ventricular tachycardia, and clinically significant second or third degree Atrioventricular (AV) block without a pacemaker\n   * History of familial long QT syndrome or known family history of Torsades de Pointe\n8. Participants in immediate need of ADT as assessed by the investigator.\n\nOther protocol defined Inclusion\u002FExclusion may apply.","MALE","18 Years","100 Years",{"count":21,"type":22},450,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) in participants with oligometastatic prostate cancer (OMPC) progressing after definitive therapy to their primary tumor. The data generated from this study will provide evidence for the treatment of AAA617 in early-stage prostate cancer patients to control recurrent tumor from progressing to fatal metastatic disease while preserving quality of life by delaying treatment with androgen deprivation therapy (ADT).",[28],"Oligometastatic Prostate Cancer (OMPC)",[30,28,31,32,33,34,35,36,37,38],"Lutetium (177Lu) vipivotide tetraxetan","Metastasis Free Survival (MFS)","gallium (68Ga) gozetotide","piflufolastat (18F)","prostate-specific membrane antigen (PSMA)","Delay Castration","Stereotactic Body Radiation Therapy (SBRT)","metastasis-directed therapy","Androgen Deprivation Therapy (ADT)-free survival.","RECRUITING","2026-06-08",{"date":42,"type":43},"2026-06-10","ACTUAL",{"date":45,"type":43},"2024-03-12",{"date":47,"type":22},"2031-10-03",{"name":49,"class":50},"Novartis Pharmaceuticals","INDUSTRY",147,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"100591274","highly-metastatic-life-prolonging-therapy-resistant-prostate-cancer-role-of-stereotactic-radiotherapy-for-bone-and-lymph-node-metastases-himars-100591274","NCT06978296","HIghly MetAstatic Life Prolonging Therapy-Resistant Prostate Cancer: Role of Stereotactic Radiotherapy for Bone and Lymph Node Metastases (HIMARS)","HIghly MetAstatic Life Prolonging Therapy-Resistant Prostate Cancer: Role of Stereotactic Radiotherapy for Bone and Lymph Node Metastases","HIMARS","Inclusion Criteria:\n\n* Metastatic prostate cancer with clinical progression after the use of androgen-receptor pathway inhibitor, chemotherapy or any other life-prolonging therapy. Patient could have been treated previously by RadioLigand Therapy (RLT).\n* Performance Status \\\u003C 3\n* Bone and\u002For lymph node metastases based on conventional (CT and bone scan) or metabolic imaging\n* Bone and\u002For lymph node metastases suitable for SRT, according to the investigator\n* Adequate organ function:\n\n  1. Absolute Neutrophil Count (ANC) ≥ 1000\u002Fmm3 or\n  2. Platelet Count ≥ 50 000\u002Fmm3 or\n  3. Haemoglobin ≥ 8 g\u002FdL (allowing transfusion or other intervention to achieve this minimum haemoglobin)\n* Age ≥ 18 years at time of study entry\n* Written informed consent obtained from the patient prior to performing any protocol-related\n* Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n* Patient has valid health insurance\n* Life time expected \\> 3 months\n\nExclusion Criteria:\n\n* Evidence of symptomatic metastases to the lungs, brain, peritoneum or liver\n* Evidence of diffuse metastatic spread to the bone marrow (e.g. positive super bone scan) or the cerebral spinal fluid as per bone scan (no lumbar puncture required).\n* Evidence of presence of symptomatic spinal cord compression with indication of neurosurgical decompression.\n* Patient with symptomatic and\u002For high-risk tumor volume-to-bone marrow reserve ratio \\> 50%\n* Concurrent enrolment in another clinical study, unless it is a non-therapeutic clinical study\n* Mental impairment (psychiatric illness\u002Fsocial situations) that may compromise the ability of the patient to give informed consent and comply with the requirements of the study;\n* Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under guardianship;\n* Patients unable to undergo medical follow-up in the study for geographical, social or psychological reasons.\n* History of another primary malignancy except for\n\n  1. Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of SRT and of low potential risk for recurrence\n  2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n  3. Adequately treated carcinoma in situ without evidence of disease\n* Uncontrolled pain that contraindicates patient positioning on the radiotherapy table according to investigator\n* Patient indicated to or currently treated by cytopenic treatment as chemotherapy or RadioLigand Therapy\n* Patient under concomitant treatment that may generate severe gastro-intestinal disorder or genito-urinary disorder",{"count":61,"type":22},18,[63],"NA","The investigators propose redefining this concept by focusing on volume rather than the number of metastases. To achieve this, the investigators aim to determine the Maximum Tolerated Volume (MTV) of metastatic lesions treatable with SRT (Stereotaxic radiotherapy) in a phase 1 study. In this study, the investigators will recruit patients with high-volume metastatic disease in bones or lymph nodes and progressively irradiate a volume-escalated subset of the total lesions. The selection will prioritize lesions at higher risk of causing pain or complications, such as fractures, spinal compression, or vascular compression. The investigators hypothesis is that SRT targeting multiple metastases (with a total volume ≤ MTV) will extend the duration without refractory pain and\u002For tumor-related complications in patients with castration-resistant and chemo-refractory prostate cancer.",[66,28],"Prostate Cancer Metastatic Disease",[68,69,70],"Radiotherapy","Stereotaxic","oligometastatic","2026-06-02",{"date":73,"type":43},"2026-06-04",{"date":75,"type":43},"2026-06-01",{"date":77,"type":22},"2030-07-01",{"name":79,"class":80},"Institut Cancerologie de l'Ouest","OTHER",1,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":23,"phases":91,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":81},"100599873","phase-1-trial-of-ptvg-hpnivotargeted-ablation-of-resistant-lesions-in-non-castrate-recurrentompc-100599873","NCT07090148","Trial of pTVG-HP+Nivo+Targeted Ablation of Resistant Lesions in Non-Castrate RecurrentOMPC","Pilot Trial of a DNA Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP) and PD-1 Blockade, With Targeted Ablation of Resistant Lesions, in Patients With Non-Castrate Recurrent Oligometastatic Prostate Cancer","Inclusion Criteria:\n\n* Participants must be at least 18 years of age with a histologic diagnosis of adenocarcinoma of the prostate\n* Participants must have undergone radical prostatectomy\n* Participants must have completed local therapy by surgery, and any adjuvant\u002Fsalvage radiation therapy (if required), at least 3 months prior to entry, with removal or ablation of all visible disease, including seminal vesical and\u002For local lymph node involvement.\n* Participants must have biochemically recurrent disease defined by the following:\n\n  * PSA doubling time, calculated from most recent 4 serum PSA values (collected up to one year prior to enrollment, at least 2 weeks apart, and all from the same clinical laboratory), must be a positive number (i.e. evidence of PSA rise over time).\n* Participants must have oligometastatic disease, defined as:\n\n  * \\\u003C 3 lesions consistent with metastases as detected by CT of the abdomen\u002Fpelvis and bone scintigraphy (bone scan)\n  * Lesions consistent with metastatic prostate cancer as detected by PSMA PET\u002FCT\n* Participants with a prior history of a second malignancy are eligible provided they have been treated with curative intent and have been free of disease greater than three years. There will be no exclusion for patients with a history of basal cell carcinoma, squamous cell skin cancer, superficial bladder cancer, or other in situ carcinoma that has been adequately treated.\n* Participants who are sexually active must use a reliable form of contraception while on study and for 4 weeks after the last immunization.\n* ECOG performance score \\\u003C 2 and life expectancy of at least 12 months.\n* Participants must have normal hematologic, renal and liver function\n* Participants must be informed of the experimental nature of the study and its potential risks and must sign an IRB-approved written informed consent form indicating such an understanding.\n* Willingness to provide blood samples for immune studies, per study calendar, up to one year after study, even if off treatment.\n\nExclusion Criteria:\n\n* Small cell or other variant prostate cancer histology\n* Participants cannot have evidence of immunosuppression or have been treated with immunosuppressive therapy, such as chemotherapy or chronic treatment dose corticosteroids (greater than the equivalent of 10 mg prednisone per day), within 3 months of the first vaccination.\n* Seropositive for HIV, hepatitis B (HBV) or hepatitis C (HCV) per patient history due to the immunosuppressive features of these diseases.\n* Prior treatment with an LHRH agonist or nonsteroidal antiandrogen, except in the following circumstances: Neoadjuvant\u002Fadjuvant androgen deprivation therapy administered with radiation therapy or at the time of prostatectomy is acceptable, provided that there was no evidence of PSA progression while on treatment. In this situation, patients must not have received more than 24 months of androgen deprivation treatment. Other treatment with androgen deprivation therapy is prohibited.\n* Serum testosterone at screening \\\u003C 50 ng\u002FdL.\n* Participants must not be concurrently taking other medications or supplements with known hormonal effects, including PC-SPES, megestrol acetate, finasteride, ketoconazole, estradiol, or Saw Palmetto. All other medications with possible anti-cancer effects must be discussed with the PI prior to study entry.\n* Participants previously treated with other potential or experimental therapies for prostate cancer must have discontinued these treatments and completed at least a 4 week washout prior to beginning treatment.\n* Participants must not have known psychological or sociological conditions, addictive disorders or family problems, which would preclude compliance with the protocol.\n* Participants with unstable or severe intercurrent medical conditions or laboratory abnormalities that would impart, in the judgment of the PI, excess risk associated with study participation or study agent administration.\n* Participants who have concurrent enrollment on other phase I, II, or III investigational therapeutic treatment studies for prostate cancer cannot be actively receiving treatment and the last dose cannot be within 4 weeks of day 1. They must be in the follow up phase of the study.",{"count":90,"type":22},14,[92],"PHASE1","The goal of this clinical trial is to learn whether an experimental vaccine called pTVG-HP (\"vaccine\" or \"DNA vaccine\"), combined with a drug called nivolumab can increase the cancer-fighting ability of a person's immune cells.\n\nThe main question it aims to answer is whether the combination of medicines can get rid of metastatic tumors in participants with non-castrate, recurrent, oligometastatic prostate cancer.\n\nParticipants will undergo:\n\n* Treatment with pTVG-HP\n* Treatment with Nivolumab\n* Radiation Therapy",[95,96,97,28],"Prostate Cancer Patients","Non-castrate Prostate Cancer","Recurrent Prostate Cancer","2026-03-09",{"date":100,"type":43},"2026-03-11",{"date":102,"type":43},"2026-03-03",{"date":104,"type":22},"2030-10",{"name":106,"class":80},"University of Wisconsin, Madison"]