Ignite Creation Date:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2025-12-26 @ 10:16 PM
Study NCT ID:
NCT05574712
Status:
WITHDRAWN
Last Update Posted:
2024-03-18
First Post:
2022-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Neoadjuvant Study of Abiraterone Acetate, Leuprolide Acetate, and Belzutifan in Men With Regional 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': 'D020360', 'term': 'Neoadjuvant Therapy'}, {'id': 'D016729', 'term': 'Leuprolide'}, {'id': 'D000069501', 'term': 'Abiraterone Acetate'}, {'id': 'C000720612', 'term': 'belzutifan'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is an evolutionary double bind, open-label, multi-site, Phase II neoadjuvant study in men with regional prostate cancer planning to undergo prostatectomy. This study will assess the rate of near pathological complete response (pCR) after 3 months (12 weeks) of neoadjuvant treatment with leuprolide acetate, abiraterone acetate, and belzutifan as assessed on prostatectomy specimens.\n\nParticipants will be treated with neoadjuvant therapy for a total of 3 months (12 weeks) prior to prostatectomy. Therapy will consist of leuprolide acetate, abiraterone acetate, and belzutifan. Each drug will be dosed at its respective FDA-approved dose. These dosages are as follows: leuprolide acetate 22.5 mg depot injection x one dose, abiraterone acetate 1000 mg by mouth daily, and belzutifan120 mg administered by mouth once daily. All men will also be treated with prednisone 5 mg by mouth twice daily while on abiraterone acetate in order to blunt its associated mineralocorticoid side effects.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Principal Investigator has decided not to activate this trial.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-14', 'studyFirstSubmitDate': '2022-10-06', 'studyFirstSubmitQcDate': '2022-10-06', 'lastUpdatePostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Overall Survival Estimate of Participants', 'timeFrame': '2 years', 'description': 'The overall survival estimate two years after the last patient has accrued.'}], 'primaryOutcomes': [{'measure': 'Rate of near pathological complete response (pCR)', 'timeFrame': '12 weeks', 'description': 'The rate of near pathological complete response (i.e. ≤5 mm of residual tumor) as assessed on prostatectomy specimens following 3-months (12 weeks) of neoadjuvant leuprolide acetate, abiraterone acetate, and belzutifan.'}], 'secondaryOutcomes': [{'measure': 'Negative Margin Rate', 'timeFrame': '12 weeks', 'description': 'The negative margin rate as assessed on prostatectomy specimens following 3-months (12 weeks) of neoadjuvant treatment'}, {'measure': 'Rate of Pathologic T3 disease', 'timeFrame': '12 weeks', 'description': 'The rate of pathologic T3 disease as assessed on prostatectomy specimens following 3-months (12 weeks) of neoadjuvant treatment.'}, {'measure': 'Rate of radiographic disappearance of prostate nodules', 'timeFrame': '12 weeks', 'description': 'Rate of radiographic disappearance of MRI detectable significant prostate nodules (i.e. ≥0.5 cm in size) following 3-months (12 weeks) of neoadjuvant treatment.'}, {'measure': 'Proportion of participants receiving adjuvant radiation therapy', 'timeFrame': 'Up to 1 year after prostatectomy', 'description': 'The proportion of men who receive adjuvant radiation therapy within 1-year of prostatectomy.'}, {'measure': 'Biochemical progression measured by Prostate Specific Antigen (PSA)', 'timeFrame': '2 years', 'description': 'The biochemical (i.e. PSA) progression free survival estimate two years after the last patient has accrued (i.e. confirmed PSA post-radical prostatectomy ≥0.2 ng/mL).'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prostate', 'prostate cancer', 'neoadjuvant', 'therapy'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'For men with prostate cancer that involves the nearby lymph nodes (N1) standard treatment varies. Many men undergo radical prostatectomy (total removal of the prostate) along with the removal of nearby lymph nodes. Other men may opt for androgen deprivation therapy (ADT, a therapy that blocks testosterone) using the two drugs leuprolide and abiraterone - with or without radiation. This research is being done to investigate whether the use of leuprolide and abiraterone, when given in combination with a drug that blocks a molecule that senses oxygen needs by cancer cells, belzutifan, can kill cancer cells in the body prior in men who are planning on having the prostate surgically removed.', 'detailedDescription': 'Eligible participants will receive 1 dose of leuprolide on day 1 as a subcutaneous injection and abiraterone and belzutifan as pills to take every day for 89 days. Participants will then undergo radical prostatectomy as a standard of care to treat prostate cancer approximately 2 weeks after finishing the study drugs. Participants will have PSA checked 1 year and 2 years after surgery. The list of study procedures (some of which are likely to be part of regular cancer care) will include the collection of data from medical records, imaging tests (CT/MRI/ Prostate-Specific Membrane Antigen Scan PSMA/ Positron Emission Tomography PET CT) to evaluate tumors, and blood collection.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Willing and able to provide written informed consent.\n2. Age ≥ 18 years\n3. Eastern cooperative group (ECOG) performance status ≤2\n4. Documented histologically confirmed adenocarcinoma of the prostate\n5. Willing to undergo prostatectomy as primary treatment for localized prostate cancer\n6. Regional prostate cancer (per National Comprehensive Cancer Network criteria): T1-4, N1, M0. Patients with negative conventional imaging may have regional prostate cancer defined by PSMA PET imaging.\n7. Serum testosterone ≥150 ng/dL\n8. Able to swallow the study drugs whole as tablets\n9. Willing to take abiraterone acetate on an empty stomach (no food should be consumed at least two hours before and for one hour after dosing).\n10. Willing to use a condom if having sex with a pregnant woman, or use a condom and another effective method of birth control if having sex with a woman of childbearing potential. These measures are required during and for one week after treatment with abiraterone acetate.\n\nExclusion Criteria:\n\n1. Prior local therapy to treat prostate cancer (e.g. radical prostatectomy, radiation therapy, brachytherapy)\n2. Prior use of enzalutamide, apalutamide, darolutamide or abiraterone acetate\n3. Prior or ongoing systemic therapy for prostate cancer including, but not limited to:\n\n 1. androgen deprivation therapy (e.g. leuprolide, goserelin, triptorelin, degarelix)\n 2. Cytochrome CYP-17 inhibitors (e.g. ketoconazole)\n 3. Treatment with 1st generation antiandrogen (e.g. bicalutamide) allowed if less than one month of therapy\n 4. Immunotherapy (e.g. sipuleucel-T, ipilimumab)\n 5. Chemotherapy (e.g. docetaxel, cabazitaxel)\n4. Evidence of serious and/or unstable pre-existing medical, psychiatric, or other conditions (including laboratory abnormalities) that could interfere with patient safety or the provision of informed consent to participate in this study.\n5. Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.\n6. Abnormal bone marrow function \\[absolute neutrophil count (ANC)\\<1500/mm3, platelet count \\<100,000/mm3, hemoglobin \\<9 g/dL\\]\n7. Abnormal liver function (bilirubin, Aspartate transaminase (AST), Alanine Transaminase (ALT) ≥ 3 x upper limit of normal)\n8. Abnormal kidney function (serum creatinine ≥ 2 x upper limit of normal)\n9. Abnormal cardiac function as manifested by the New York Heart Association (NYHA) class III or IV heart failure or history of a prior myocardial infarction (MI) within the last five years before enrollment in the study.\n10. History of prior cardiac arrhythmia\n11. Baseline pulse oximetry of \\<90%'}, 'identificationModule': {'nctId': 'NCT05574712', 'briefTitle': 'A Neoadjuvant Study of Abiraterone Acetate, Leuprolide Acetate, and Belzutifan in Men With Regional Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}, 'officialTitle': 'An Evolutionary Double Bind Phase II Neoadjuvant Study of Abiraterone Acetate, Leuprolide Acetate, and Belzutifan in Men With Regional Prostate Cancer Eligible for Prostatectomy', 'orgStudyIdInfo': {'id': 'J2258'}, 'secondaryIdInfos': [{'id': 'IRB00338335', 'type': 'OTHER', 'domain': 'JHM IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open-Label Treatment Group', 'description': 'Participants will be treated with neoadjuvant therapy for a total of 3 months (12 weeks) prior to prostatectomy. Therapy will consist of leuprolide acetate, abiraterone acetate, and belzutifan.', 'interventionNames': ['Drug: Neoadjuvant treatment']}], 'interventions': [{'name': 'Neoadjuvant treatment', 'type': 'DRUG', 'otherNames': ['leuprolide acetate', 'abiraterone acetate', 'belzutifan'], 'description': 'Each drug will be dosed at its respective FDA-approved dose. These dosages are as follows: leuprolide acetate 22.5 mg depot injection x one dose, abiraterone acetate 1000 mg by mouth daily, and belzutifan120 mg administered by mouth once daily. All men will also be treated with prednisone 5 mg by mouth twice daily while on abiraterone acetate in order to blunt its associated mineralocorticoid side effects', 'armGroupLabels': ['Open-Label Treatment Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ken Pienta, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}