Ignite Creation Date:
2025-12-24 @ 4:53 PM
Ignite Modification Date:
2025-12-29 @ 1:22 AM
Study NCT ID:
NCT05568550
Status:
RECRUITING
Last Update Posted:
2025-07-25
First Post:
2022-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pembro With Radiation With or Without Olaparib
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': 'C582435', 'term': 'pembrolizumab'}, {'id': 'C531550', 'term': 'olaparib'}, {'id': 'D000726', 'term': 'Androgen Antagonists'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D006727', 'term': 'Hormone Antagonists'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1:1'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2029-07-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2022-09-29', 'studyFirstSubmitQcDate': '2022-10-03', 'lastUpdatePostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'PSA Progression-Free Survival', 'timeFrame': '3 years (Pre-treatment baseline, cycle 3, 6 months or at disease progression)', 'description': 'PSA progression-free survival (PSA-PFS) stratified by PDL1 immunohistochemistry expression on baseline or /archival biopsy tissue, if tissue is available.'}, {'measure': 'Correlation between clinical outcome and immune cell subtype.', 'timeFrame': '3 years (Pre-treatment baseline, cycle 3, 6 months or at disease progression)', 'description': 'Correlation between the clinical outcomes and changes in immune cell subtype frequencies (% CD4 T cells, % CD8 T cells, % naïve, effector memory, and T regulatory cells) immune functions (T cell ability to induce cytokine following stimulation).'}, {'measure': 'Correlation between clinical outcome and cytokine levels.', 'timeFrame': '3 years (Pre-treatment baseline, cycle 3, 6 months or at disease progression)', 'description': 'Correlation between the serum cytokines (IL2, IL-10, and INF-γ) and clinical outcomes.'}, {'measure': 'Correlation between clinical outcomes and TCR repertories clonotypes.', 'timeFrame': '3 years (Pre-treatment baseline, cycle 3, 6 months or at disease progression)', 'description': 'Correlation between T cell receptor (TCR) repertories clonotypes and clinical outcomes.'}, {'measure': 'Percent changes in plasma circulating tumor DNA', 'timeFrame': 'Baseline and on-treatment (6 months)', 'description': 'Percent changes in plasma circulating tumor DNA (ctDNA).'}], 'primaryOutcomes': [{'measure': 'Clinical Response Rate', 'timeFrame': '6 months', 'description': 'The proportion of patients who achieve a PSA nadir level of ≤ 0.06ng/mL six months after completion of radiation therapy.'}], 'secondaryOutcomes': [{'measure': 'Biochemical-Free Survival', 'timeFrame': '3 years', 'description': 'Biochemical-free survival rate at 3 years as defined by Phoenix Criteria.'}, {'measure': 'Metastasis-Free Survival', 'timeFrame': '3 years', 'description': 'Metastasis-free survival rate at 3 years as defined by RECIST v1.1 criteria.'}, {'measure': 'Time to Normalization of Serum Testosterone', 'timeFrame': '3 years', 'description': 'Time from normalization is the date of first return to normal serum testosterone 270 ng/ml or greater after withdrawal of androgen deprivation therapy.'}, {'measure': 'Molecular Alterations in Homologous Recombination Repair Genes', 'timeFrame': '3 years', 'description': 'Molecular alterations in the homologous recombination repair (HHR) genes.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['immunotherapy', 'PARP', 'radiation', 'androgen deprivation therapy', 'ADT', 'PD-1'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This trial will evaluate whether the immune-sensitizing effects of immunotherapy (Pembrolizumab) and radiation with or without a PARP-inhibitor (Olaparib) will increase the effects of immunotherapy in men with high-risk localized prostate cancer.', 'detailedDescription': 'Immunotherapy and PARP-inhibitor are known to have radio-sensitizing effects when combined with radiation therapy. In addition, the combination with PARP-inhibitor and radiation can increase neoantigen expression, cytotoxic lymphocyte infiltration within the tumor microenvironment and increased immune stimulating cytokine concentration. Thus, there is a potential synergy of combining immunotherapy and PARP-inhibitor.\n\nThis is a phase 2 randomized 1:1 study. Subjects will be randomized to one arm (pembro + PARPi + standard of care therapy which is definitive radiation therapy combined with hormonal therapy) vs. another arm (pembro + standard of care therapy). All subjects will receive adjuvant immunotherapy for one year once they are done with definitive radiation treatment.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male participants with histologically confirmed adenocarcinoma of the prostate\n* High-risk / very high-risk status per NCCN guidelines\n* ECOG performance status 0 to 1\n* Regional lymph nodes are allowed.\n* Agree to use contraception during the treatment period and for at least 120 days after the last dose of study intervention and refrain from donating sperm during this period.\n* Ability to understand and the willingness to sign a written informed consent document.\n* Adequate organ and marrow function\n* Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation is ≤90 days prior to the date of registration\n* Prior 5-alpha reductase inhibitor (for example, finasteride) for prostatic hypertrophy is allowed if discontinued at least 60 days prior to registration.\n* 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.\n\nExclusion Criteria:\n\n* PSA \\> 150ng/ml\n* Prior hormonal therapy with LHRH agonists (e.g., Lupron) and LHRH antagonists (e.g., Degarelix)for prostate cancer continuously for more than 90-days prior to study enrollment.\n* Prior radiation to the prostate. Previous pelvic RT or major surgery (colorectal anastomosis, total cystectomy, radical prostatectomy, TURP, etc.). History of Ulcerative proctitis.\n* Concurrent active, additional malignancy in the last 2 years.\n* Prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to randomization.\n* Patients with M1 disease'}, 'identificationModule': {'nctId': 'NCT05568550', 'briefTitle': 'Pembro With Radiation With or Without Olaparib', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Phase II Study of Pembrolizumab in Combination With Radiation With or Without Olaparib in Localized High-risk Prostate Cancer', 'orgStudyIdInfo': {'id': 'MCC-22-GU-80'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1 - Pembrolizumab and Olaparib', 'description': 'Patients with high-risk prostate cancer receiving combination therapy with Pembrolizumab and Olaparib.', 'interventionNames': ['Biological: Pembrolizumab', 'Drug: Olaparib', 'Drug: Androgen Deprivation Therapy', 'Radiation: Radiation Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2 - Pembrolizumab', 'description': 'Patients with high-risk prostate cancer receiving combination therapy with Pembrolizumab.', 'interventionNames': ['Biological: Pembrolizumab', 'Drug: Androgen Deprivation Therapy', 'Radiation: Radiation Therapy']}], 'interventions': [{'name': 'Pembrolizumab', 'type': 'BIOLOGICAL', 'otherNames': ['Keytruda'], 'description': 'Pembrolizumab will be delivered via IV at 200mg on day 1 of each 3-week cycle for approximately 12 months. Cycle 1 begins 21 days prior to radiation therapy and cycles 2-17 are administered during and after radiation therapy.', 'armGroupLabels': ['Arm 1 - Pembrolizumab and Olaparib', 'Arm 2 - Pembrolizumab']}, {'name': 'Olaparib', 'type': 'DRUG', 'otherNames': ['Lynparza'], 'description': '200mg Olaparib will be given twice daily for a total of 3 cycles. Cycle 1 begins 21-days prior to radiation therapy.', 'armGroupLabels': ['Arm 1 - Pembrolizumab and Olaparib']}, {'name': 'Androgen Deprivation Therapy', 'type': 'DRUG', 'description': 'Androgen Deprivation Therapy (either LHRH agonist or LHRH antagonist) as per treating physician choice will be allowed within 3 months prior to randomization. Duration is per institutional standards.', 'armGroupLabels': ['Arm 1 - Pembrolizumab and Olaparib', 'Arm 2 - Pembrolizumab']}, {'name': 'Radiation Therapy', 'type': 'RADIATION', 'description': 'Definitive radiation (total dose and fractions) will be dosed per institutional standards. Definitive radiation may include external beam radiation therapy with or without brachytherapy, based on NCCN risk score and as per treating physicians.', 'armGroupLabels': ['Arm 1 - Pembrolizumab and Olaparib', 'Arm 2 - Pembrolizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yvonne Taul, RN,CCRC', 'role': 'CONTACT', 'email': 'yvonne.taul@uky.edu', 'phone': '859-323-2354'}, {'name': 'Zin Myint, MD', 'role': 'CONTACT', 'email': 'zin.myint@uky.edu', 'phone': '410236809'}], 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Benjamin Maughan, MD, PharmD', 'role': 'CONTACT', 'email': 'benjamin.maughan@hci.utah.edu', 'phone': '801-581-2267'}], 'facility': 'Huntsman Cancer Institute', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'centralContacts': [{'name': 'Bryan Courtney', 'role': 'CONTACT', 'email': 'bryancourtney@uky.edu', 'phone': '859-257-3379'}], 'overallOfficials': [{'name': 'Zin W Myint, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zin W Myint', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Zin W Myint', 'investigatorAffiliation': 'University of Kentucky'}}}}