Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-24 @ 4:57 PM
Study NCT ID:
NCT06854250
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-03
First Post:
2025-02-20
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prostate Cryoablation Combined with Metronomic Cyclophosphamide for Metastatic Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003520', 'term': 'Cyclophosphamide'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 104}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2030-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-25', 'studyFirstSubmitDate': '2025-02-20', 'studyFirstSubmitQcDate': '2025-02-25', 'lastUpdatePostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PSA progression-free survival', 'timeFrame': 'From date of initiation of androgen deprivation therapy until the date of PSA progression or date of death from any cause, whichever came first, assessed up to 5 years', 'description': 'Defined as the time from the initiation of androgen deprivation therapy to the occurrence of PSA progression or death.'}], 'secondaryOutcomes': [{'measure': 'Radiographic progression-free survival', 'timeFrame': 'From date of initiation of androgen deprivation therapy until the date of radiographic progression or date of death from any cause, whichever came first, assessed up to 5 years', 'description': 'Defined as the time from the initiation of androgen deprivation therapy to the occurrence of radiographic progression of death.'}, {'measure': 'mCRPC-free survival', 'timeFrame': 'From date of initiation of androgen deprivation therapy until the date of progression to metastatic castration-resistant prostate cancer or date of death from any cause, whichever came first, assessed up to 5 years', 'description': 'Defined as the time from the initiation of androgen deprivation therapy to progression to metastatic castration-resistant prostate cancer (mCRPC) or death.'}, {'measure': 'Overall survival', 'timeFrame': 'From date of initiation of androgen deprivation therapy until the date of death from any cause, assessed up to 5 years', 'description': 'Defined as the time from the initiation of androgen deprivation therapy to death from any cause.'}, {'measure': 'Incidence of symptomatic local events', 'timeFrame': 'Through study completion, an average of 3 year', 'description': 'Symptomatic local events are defined as any of the following conditions: urinary tract infection, indwelling catheterization, acute kidney injury, transurethral resection of the prostate, urinary obstruction, indwelling ureteral stent placement, nephrostomy, colostomy, or surgery for intestinal obstruction.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metastatic prostate cancer', 'Novel androgen receptor inhibitors', 'Prostate cryoablation', 'Cyclophosphamide'], 'conditions': ['Metastatic Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '19307997', 'type': 'BACKGROUND', 'citation': 'Si T, Guo Z, Hao X. Combined cryoablation and GM-CSF treatment for metastatic hormone refractory prostate cancer. J Immunother. 2009 Jan;32(1):86-91. doi: 10.1097/CJI.0b013e31818df785.'}, {'pmid': '19937954', 'type': 'BACKGROUND', 'citation': 'Donnelly BJ, Saliken JC, Brasher PM, Ernst SD, Rewcastle JC, Lau H, Robinson J, Trpkov K. A randomized trial of external beam radiotherapy versus cryoablation in patients with localized prostate cancer. Cancer. 2010 Jan 15;116(2):323-30. doi: 10.1002/cncr.24779.'}, {'pmid': '30638633', 'type': 'BACKGROUND', 'citation': 'Shah TT, Peters M, Eldred-Evans D, Miah S, Yap T, Faure-Walker NA, Hosking-Jervis F, Thomas B, Dudderidge T, Hindley RG, McCracken S, Greene D, Nigam R, Valerio M, Minhas S, Winkler M, Arya M, Ahmed HU. Early-Medium-Term Outcomes of Primary Focal Cryotherapy to Treat Nonmetastatic Clinically Significant Prostate Cancer from a Prospective Multicentre Registry. Eur Urol. 2019 Jul;76(1):98-105. doi: 10.1016/j.eururo.2018.12.030. Epub 2019 Jan 9.'}, {'pmid': '38575408', 'type': 'BACKGROUND', 'citation': 'Tsuboi I, Matsukawa A, Kardoust Parizi M, Klemm J, Mancon S, Chiujdea S, Fazekas T, Miszczyk M, Laukhtina E, Kawada T, Katayama S, Iwata T, Bekku K, Karakiewicz P, Wada K, Roupret M, Araki M, Shariat SF. A Systematic Review and Meta-analysis of the Impact of Local Therapies on Local Event Suppression in Metastatic Hormone-sensitive Prostate Cancer. Eur Urol Oncol. 2024 Dec;7(6):1185-1194. doi: 10.1016/j.euo.2024.03.007. Epub 2024 Apr 4.'}, {'pmid': '35440168', 'type': 'BACKGROUND', 'citation': 'Li Y, Wang N, Zhao D, Wang J, Jiang L, Wang Y, Chen D, Wu Z, Zhou F, Yang Z. Cytoreductive prostate cryoablation and metronomic cyclophosphamide for metastatic hormone-sensitive prostate cancer. Future Oncol. 2022 Jun;18(19):2373-2380. doi: 10.2217/fon-2021-1424. Epub 2022 Apr 20.'}, {'pmid': '33664457', 'type': 'BACKGROUND', 'citation': 'Wang N, Ye Y, Deng M, Zhao D, Jiang L, Chen D, Wu Z, Wang Y, Li Z, Yang Z, Li J, Zhou F, Li Y. Prostate cryoablation combined with androgen deprivation therapy for newly diagnosed metastatic prostate cancer: a propensity score-based study. Prostate Cancer Prostatic Dis. 2021 Sep;24(3):837-844. doi: 10.1038/s41391-021-00335-2. Epub 2021 Mar 4.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to explore whether androgen deprivation therapy combined with novel androgen receptor inhibitors, prostate cryoablation, and metronomic cyclophosphamide is superior to the current treatment regimen of androgen deprivation therapy plus novel androgen receptor inhibitors for patients with metastatic prostate cancer. It will also learn about the safety of prostate cryoablation, and metronomic cyclophosphamide for patients with metastatic prostate cancer. The main questions it aims to answer are:\n\nDoes prostate cryoablation, and metronomic cyclophosphamide delay the progression of metastatic prostate cancer? Does prostate cryoablation, and metronomic cyclophosphamide reduce symptomatic local events of metastatic prostate cancer?\n\nResearchers will explore if androgen deprivation therapy combined with novel androgen receptor inhibitors, prostate cryoablation, and metronomic cyclophosphamide works to treat metastatic prostate cancer.\n\nParticipants will:\n\nReceive treatment of androgen deprivation therapy and novel androgen receptor inhibitors until progression.\n\nReceive prostate cryoablation surgery and take cyclophosphamide. Visit the clinic every 1-3 months for checkups and tests. Keep a diary of their symptoms.', 'detailedDescription': 'This study aims to evaluate the efficacy and safety of combining prostate cryoablation and cyclophosphamide with androgen deprivation therapy plus novel androgen receptor inhibitors (apalutamide, rezvilutamide, or darolutamide) in patients with newly diagnosed, metastatic prostate cancer. By comparing with previous studies, it seeks to explore whether prostate cryoablation and cyclophosphamide treatment can confer survival benefits and reduce symptomatic local urinary events in these patients.\n\nPatients with newly diagnosed, metastatic prostate cancer who meet the inclusion criteria after evaluation will receive treatment with androgen deprivation therapy plus a novel androgen receptor inhibitor (apalutamide, rezvilutamide, or darolutamide) in combination with prostate cryoablation and cyclophosphamide. Enrolled patients should start the novel androgen receptor inhibitor (apalutamide, rezvilutamide, or darolutamide) within 3 months of initiating androgen deprivation therapy and undergo prostate cryoablation within 6 months of starting androgen deprivation therapy. Cyclophosphamide treatment will begin one day after prostate cryoablation and continue for a total of six months.\n\nThe primary endpoint of the study is PSA progression-free survival. Secondary endpoints include: 1) radiographic progression-free survival, 2) time to progression to metastatic castration-resistant prostate cancer, 3) overall survival, 4) PSA nadir, 5) incidence of symptomatic local events, and 6) safety.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males between 18 and 80 years old;\n* Histopathological confirmation of prostatic acinar adenocarcinoma;\n* Diagnosed with metastatic prostate cancer at initial diagnosis according to the AJCC 8th edition staging criteria;\n* No progression at the time of initiating of prostate cryoablation;\n* ECOG score of 0-1;\n* Can tolerate general anesthesia and prostate cryoablation surgery;\n* No significant abnormalities .\n* Able to understand this study and sign the informed consent form.\n\nExclusion Criteria:\n\n* Serious illness not suitable to receive the treatment regimen;\n* Other malignant tumors (within 5 years), except for non-melanoma skin cancer;\n* Receipt of treatments other than treatment regimen of this study;\n* Prostate cancer invading the rectum;\n* with prostate volumegreater than 55ml after 6 months of androgen deprivation therapy .'}, 'identificationModule': {'nctId': 'NCT06854250', 'briefTitle': 'Prostate Cryoablation Combined with Metronomic Cyclophosphamide for Metastatic Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Androgen Deprivation Therapy Combined with Novel Androgen Receptor Inhibitors, Prostate Cryoablation, and Cyclophosphamide in the Treatment of Newly Diagnosed, Metastatic Prostate Cancer: a Single-Center, Single-Arm, Prospective Clinical Study', 'orgStudyIdInfo': {'id': '2024-FXY-295'}, 'secondaryIdInfos': [{'id': 'SL-B2024-623-02', 'type': 'OTHER', 'domain': 'Sun Yst-sen University Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prostate cryoablation and cyclophosphamide', 'description': 'Metastatic prostate cancer patients receive prostate cryoablation and metronomic cyclophosphamide in addition to androgen deprivation therapy and novel androgen receptor inhibitors.', 'interventionNames': ['Procedure: Prostate cryoablation', 'Drug: Cyclophosphamide (CTX)']}], 'interventions': [{'name': 'Prostate cryoablation', 'type': 'PROCEDURE', 'description': 'Enrolled patients will receive prostate cryoablation within 6 months of starting androgen deprivation therapy.', 'armGroupLabels': ['Prostate cryoablation and cyclophosphamide']}, {'name': 'Cyclophosphamide (CTX)', 'type': 'DRUG', 'description': 'Enrolled patients will receive cyclophosphamide (50mg daily) one day after prostate cryoablation and continue for a total of six months.', 'armGroupLabels': ['Prostate cryoablation and cyclophosphamide']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Zhenyu Yang, Dr.', 'role': 'CONTACT', 'email': 'yangzy@sysucc.org.cn', 'phone': '86-1390229060'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Director', 'investigatorFullName': 'Yonghong Li', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}