Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-01-02 @ 9:56 AM
Study NCT ID:
NCT06798558
Status:
RECRUITING
Last Update Posted:
2025-03-11
First Post:
2025-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Lu-177-PSMA-617 in Patients With High Risk Localized Prostate Cancer Undergoing Radical Prostatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2029-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-07', 'studyFirstSubmitDate': '2025-01-17', 'studyFirstSubmitQcDate': '2025-01-22', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prostate cancer down-staging following treatment with Lu-177-PSMA-617 (PluvictoⓇ) defined by Gleason Grade Group', 'timeFrame': 'Patients will undergo a PSMA PET/CT scans up to week 11 +/- 30 days prior to radical prostatectomy with pelvic lymph node dissection.', 'description': 'Staging of prostate cancer is based on the correlation to Gleason Grade Group (GG) according to the American Joint Committee on Cancer (AJCC; 8TH edition, 2017) staging system for prostate cancer (see Appendix A). Prostate cancer downstaging is defined as the post-treatment stage less than the pre-treatment stage. Different downstaging thresholds will be applied including:\n\n* Complete downstaging (CD) is defined as no visible tumor in surgical sample;\n* Good response (GR) is defined as downstaging from high risk disease (GG4 or greater) to intermediate risk pathologic disease (GG2 or GG3 disease); and\n* Very good response (VGR) is defined as downstaging from high-risk disease (GG4 or greater) to low risk pathologic disease (GG1 disease).'}], 'secondaryOutcomes': [{'measure': 'Prostate cancer down-staging following treatment with Lu-177-PSMA-617 (PluvictoⓇ) as defined by margin status, T staging, and seminal vesicle involvement', 'timeFrame': 'Patients will undergo a PSMA PET/CT scans up to week 11 +/- 30 days prior to radical prostatectomy with pelvic lymph node dissection.', 'description': 'Staging of prostate cancer is based on the American Joint Committee on Cancer (AJCC; 8TH edition, 2017) combining the TNM staging system for prostate cancer with the Gleason Grade Group (GG)'}, {'measure': 'Decrease in PSMA-avid tumor load', 'timeFrame': 'Patients will undergo a SOC PSMA PET/CT scans up to week 11 +/- 30 days prior to radical prostatectomy with pelvic lymph node dissection.', 'description': 'Decrease in PSMA-avid tumor load is measured by comparing the extent of PSMA-avid tumor before and after Lu-177-PSMA-617 (PluvictoⓇ). High PSMA-avidity is defined as more than 2 times the liver activity. Low PSMA-avidity is defined as less than 2 times liver activity. The volumes of PSMA-avid disease will be summed up to quantify the extent of PSMA-avid tumor load before and after Lu-177-PSMA-617 (PluvictoⓇ). PSMA-positive disease is measured using 68Ga-PSMA-11 PET/CT scan.'}, {'measure': 'Safety of radical prostatectomy assessed by surgical delay time', 'timeFrame': 'Patients will be assessed for toxicity throughout treatment with Lu-177-PSMA-617 (PluvictoⓇ) and during surgery. Following treatment with Lu-177-PSMA-617 (PluvictoⓇ) and surgery, all participants will be followed for safety with a 30-day safety follow-up', 'description': 'The safety of radical prostatectomy and pelvic lymph node dissection following Lu-177-PSMA-617 (PluvictoⓇ) is defined as the surgical delay time. Surgical delay time is defined as days between the last dose of Lu-177-PSMA-617 (PluvictoⓇ) and the date of radical prostatectomy. All surgeries will be assessed by each surgeon at the end of the procedure and graded as similar to, more difficult than, or significantly more difficult than expected for a high-risk radical prostatectomy (Eapen 2023). Adverse events (AEs) of Lu-177-PSMA-617 (PluvictoⓇ) and surgery will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 or severity grade when CTCAE grading does not exist.'}, {'measure': 'Safety of radical prostatectomy assessed by rate of intraoperative and postoperative complications', 'timeFrame': 'Patients will be assessed for toxicity throughout treatment with Lu-177-PSMA-617 (PluvictoⓇ) and during surgery. Following treatment with Lu-177-PSMA-617 (PluvictoⓇ) and surgery, all participants will be followed for safety with a 30-day safety follow-up', 'description': 'The safety of radical prostatectomy and pelvic lymph node dissection following Lu-177-PSMA-617 (PluvictoⓇ) is defined as the rate of intraoperative and postoperative complications. All surgeries will be assessed by each surgeon at the end of the procedure and graded as similar to, more difficult than, or significantly more difficult than expected for a high-risk radical prostatectomy (Eapen 2023). Adverse events (AEs) of Lu-177-PSMA-617 (PluvictoⓇ) and surgery will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 or severity grade when CTCAE grading does not exist.'}, {'measure': 'Safety of radical prostatectomy assessed by the amount of blood loss', 'timeFrame': 'Patients will be assessed for toxicity throughout treatment with Lu-177-PSMA-617 (PluvictoⓇ) and during surgery. Following treatment with Lu-177-PSMA-617 (PluvictoⓇ) and surgery, all participants will be followed for safety with a 30-day safety follow-up', 'description': 'The safety of radical prostatectomy and pelvic lymph node dissection following Lu-177-PSMA-617 (PluvictoⓇ) is defined as the amount of blood loss. All surgeries will be assessed by each surgeon at the end of the procedure and graded as similar to, more difficult than, or significantly more difficult than expected for a high-risk radical prostatectomy (Eapen 2023). Adverse events (AEs) of Lu-177-PSMA-617 (PluvictoⓇ) and surgery will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 or severity grade when CTCAE grading does not exist.'}, {'measure': 'Safety of radical prostatectomy assessed by percentage of periprostatic adhesion', 'timeFrame': 'Patients will be assessed for toxicity throughout treatment with Lu-177-PSMA-617 (PluvictoⓇ) and during surgery. Following treatment with Lu-177-PSMA-617 (PluvictoⓇ) and surgery, all participants will be followed for safety with a 30-day safety follow-up', 'description': 'The safety of radical prostatectomy and pelvic lymph node dissection following Lu-177-PSMA-617 (PluvictoⓇ) is defined as the percentage of periprostatic adhesion. All surgeries will be assessed by each surgeon at the end of the procedure and graded as similar to, more difficult than, or significantly more difficult than expected for a high-risk radical prostatectomy (Eapen 2023). Adverse events (AEs) of Lu-177-PSMA-617 (PluvictoⓇ) and surgery will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 or severity grade when CTCAE grading does not exist.'}, {'measure': 'Safety of radical prostatectomy assessed by the surgical length of time', 'timeFrame': 'Patients will be assessed for toxicity throughout treatment with Lu-177-PSMA-617 (PluvictoⓇ) and during surgery. Following treatment with Lu-177-PSMA-617 (PluvictoⓇ) and surgery, all participants will be followed for safety with a 30-day safety follow-up', 'description': 'The safety of radical prostatectomy and pelvic lymph node dissection following Lu-177-PSMA-617 (PluvictoⓇ) is defined as the surgical length of time. All surgeries will be assessed by each surgeon at the end of the procedure and graded as similar to, more difficult than, or significantly more difficult than expected for a high-risk radical prostatectomy (Eapen 2023). Adverse events (AEs) of Lu-177-PSMA-617 (PluvictoⓇ) and surgery will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 or severity grade when CTCAE grading does not exist.'}, {'measure': 'Quality-of-life and sexual function changes', 'timeFrame': 'The EPIC-26 questionnaire will be completed by patients up to 24 months after prostatectomy', 'description': 'Quality-of-life and sexual function changes following treatment with Lu-177-PSMA-617 (PluvictoⓇ) and prostatectomy will be measured using the Expanded Prostate Index Composite (EPIC)-26 questionnaire.'}, {'measure': 'Biochemical recurrence of prostate cancer at 2 years', 'timeFrame': 'PSA levels will be measured up to 24 months after prostatectomy', 'description': 'Biochemical recurrence is defined as a serum prostate-specific antigen (PSA) level more than 0.2 ng/mL on 2 consecutive measurements performed at least 3 months apart.\n\nTimeframe: PSA levels will be measured at screening/baseline, at the initiation of treatment'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Adenocarcinoma']}, 'referencesModule': {'references': [{'pmid': '24149515', 'type': 'BACKGROUND', 'citation': 'Aalberts M, Stout TA, Stoorvogel W. 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Epub 2021 Feb 4.'}, {'pmid': '9083160', 'type': 'BACKGROUND', 'citation': 'Zagars GK, Pollack A, von Eschenbach AC. Prognostic factors for clinically localized prostate carcinoma: analysis of 938 patients irradiated in the prostate specific antigen era. Cancer. 1997 Apr 1;79(7):1370-80.'}]}, 'descriptionModule': {'briefSummary': 'Male adults with a confirmed diagnosis of prostate adenocarcinoma who meet criteria for localized high risk prostate cancer according to the NCCN guidelines and who are eligible for prostatectomy will be invited to participate. Criteria for high-risk prostate cancer include patients with preoperative prostate biopsy score of Gleason 8 (GS8) (Grade group 4 \\[GG4\\]) or higher. Patients also need to have a positive PSMA scan on 68-Ga-PSMA-11 PET/CT scan.', 'detailedDescription': 'The PRELUDE trial is a prospective, non-randomized, single-arm, phase 2 interventional study to assess the oncological outcomes after 2 cycles of Lu-177-PSMA-617 (PluvictoⓇ) administered at 6-week intervals before prostatectomy in patients with high risk localized prostate cancer.\n\nPatients who meet all the inclusion criteria for the study will be enrolled to receive 2 cycles of Lu-177-PSMA-617 (PluvictoⓇ) administered at the dose of 7.4 GBq (±10%), once every 6 weeks (±1 week). Six weeks after the second cycle of Lu-177-PSMA-617 (PluvictoⓇ), patients will be eligible for radical prostatectomy with pelvic lymph node dissection and remain eligible for surgery up until 30 days from this timepoint.\n\nFollowing treatment with Lu-177-PSMA-617 (PluvictoⓇ) and surgery, all participants will be followed for safety at week 3, 6, 9, 11, and 12 as well as a 30-day safety follow-up visit (FUP) and longer term safety follow-up assessments every 3 months for a period of approximately 2 years. Patients who experience disease progression will be managed according to standard treatment guidelines recommendations.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients age 18 or older.\n* Patients with histologically confirmed adenocarcinoma of the prostate.\n* Patients with high-risk disease defined as a preoperative prostate biopsy of Gleason Score 8 (GS8) (Grade group 4 \\[GG4\\]) or higher. Men with evidence of lymph node involvement at or below the bifurcation of the common iliac arteries (cN1) on PET-CT 68Ga-PSMA-11 are eligible.\n* Pre-operative, pre-treatment PSMA scan with high expression in prostate confirmed by PET/CT 68Ga-PSMA-11 (greater than liver). Patients must not have any other PET FDG-positive sites outside the prostate.\n* Patients who are able and willing to undergo surgery.\n* Patients with a life expectancy of greater than 10 years. Life expectancy can be estimated using any 1 of the following tools:\n\n * The Social Security Administration tables:\n\nhttps://www.ssa.gov/OACT/STATS/table4c6.html\n\n* The WHO's Life Tables by country:\n\nhttps://apps.who.int/gho/data/view.main.60000?lang=en\n\n* The Memorial Sloan Kettering Male Life Expectancy tool:\n\nhttps://www.mskcc.org/nomograms/prostate\n\n* If using a life expectancy table, life expectancy should be adjusted using the clinician's assessment of overall health as follows: best quartile of health - add 50%; worst quartile of health - subtract 50%; and middle two quartiles of health - no adjustment. See the NCCN Prostate Cancer Guidelines for more information.\n\n * Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n * Patients who agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agree to refrain from donating sperm, as defined below:\n* With a female partner of childbearing potential who is not pregnant, men who are not surgically sterile must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\< 1% per year during the treatment period and for 14 weeks after the final dose of study treatment. Men must refrain from donating sperm during this same period.\n* With a pregnant female partner, men must remain abstinent or use a condom during the treatment period and for 14 weeks after the final dose of study treatment to avoid potential exposure to the embryo.\n* The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not adequate methods of contraception.\n\n * Patients who are able to comply with follow-up visits and treatment plans.\n * Patients who are able to give informed consent.\n\nExclusion Criteria:\n\n* Patients with a prior history of prostate cancer treatment.\n* Patients with previous treatment with PSMA-targeted radioligand therapy or any of the following within 6 months of enrollment confirmation: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or hemi-body irradiation.\n* Patients with distant disease (outside of local lymph nodes).\n* Significant bone marrow impairment defined by leukocytes \\<3,000/mcL, absolute neutrophil count (ANC) \\<1,500/mcL, and platelet count lower than 70,000/mcL.\n* Significant liver function impairment defined by total bilirubin higher than 1.5 times the upper limit of normal (ULN), andASL/ALT higher than 3 times the ULN.\n* Impaired kidney function defined by glomerular filtration rate (GFR) lower than 40 mL/min, or concomitant use of nephrotoxic drugs. Kidney function based on eGFR by Modification of Diet in Renal Disease (MDRD) equation:\n\n * Normal renal function: participants with eGFR 90 mL/min\n * Moderate renal impairment: participants with eGFR 30 to 59 mL/min\n * Severe renal impairment: participants with eGFR 15 to 29 mL/min\n* Patients with significant comorbidities that would make them poor candidates for surgery.\n* Patients with evidence of metastatic disease (enlarged lymph nodes, distant metastatic sites, visceral or bone metastases, etc.).\n* Patients with a history of radiation or hormone therapy to the prostate.\n* Patients with a history of bleeding disorders or who are taking anticoagulant therapy.\n* Patients with active infections or other contraindications for surgery.\n* Patients who are unable or unwilling to give informed consent.\n* Patients who are unable to comply with follow-up visits and treatment plans"}, 'identificationModule': {'nctId': 'NCT06798558', 'briefTitle': 'Neoadjuvant Lu-177-PSMA-617 in Patients With High Risk Localized Prostate Cancer Undergoing Radical Prostatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Hackensack Meridian Health'}, 'officialTitle': 'Phase II Study of Neoadjuvant Lu-177-PSMA-617 in Patients With High Risk Localized Prostate Cancer Undergoing Radical Prostatectomy', 'orgStudyIdInfo': {'id': 'PRELUDE'}, 'secondaryIdInfos': [{'id': 'CAAA617A1US07T', 'type': 'OTHER_GRANT', 'domain': 'Novartis'}, {'id': 'Pro2024-0079', 'type': 'OTHER', 'domain': 'HMH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lu-177-PSMA-617 Treatment', 'description': 'Patients will receive 2 cycles of Lu-177-PSMA-617 (PluvictoⓇ) administered at the dose of 7.4 GBq (±10%), once every 6 weeks (±1 week)', 'interventionNames': ['Drug: Lu-17-PSMA-617']}], 'interventions': [{'name': 'Lu-17-PSMA-617', 'type': 'DRUG', 'description': 'Lu-17-PSMA-617 administration', 'armGroupLabels': ['Lu-177-PSMA-617 Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ross Krasnow, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MedStar Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20057', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Paul Leger, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lombardi Comprehensive Cancer Center at Georgetown University Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nitin Yerram, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'John Theurer Cancer Center at Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}], 'centralContacts': [{'name': 'Oncology Clinical Research Referral Office', 'role': 'CONTACT', 'email': 'OncologyResearchReferral@hmhn.org', 'phone': '551-996-1777'}], 'overallOfficials': [{'name': 'Nitin Yerram, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hackensack Meridian Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hackensack Meridian Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lombardi Comprehensive Cancer Center', 'class': 'OTHER'}, {'name': 'Novartis', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}