N
← Back to Search
Sponsored

Accelerate Your Clinical Trial Recruitment

Reach thousands of high-intent patients matching your specific inclusion criteria.

Start Campaign
RECRUITING Phase 3 ClinicalTrials.gov

Testing Different Dosing Schedules of the Anti-cancer Drug, Lutetium 177Lu PSMA RLT and Its Effect on Patients With Advanced Prostate Cancer, RECIPROCAL Trial

Sponsor: Alliance for Clinical Trials in Oncology • ClinicalTrials.gov ID: NCT07200830

Registry updated: 2026-10-02
Ad

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Check Eligibility →

Description

This randomized phase III trial examines whether lengthening the dosage interval in an adaptive manner for the prostate cancer drug lutetium 177 Lu PSMA RLT improves quality of life without decreasing lifespan when compared to the standard way this medication is given. This study is for patients with hormone resistant prostate cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body. Hormone resistant prostate cancer often has many cells containing a protein called prostate-specific membrane antigen (PSMA) on their surface. The normal cells in the prostate do not normally express as much PSMA protein on their surface as cancer cells. Lutetium 177 Lu PSMA RLT binds to the PSMA protein on the tumor cells. It builds up in these cells and gives off radiation that may kill them. Typically, this medication is given at the same dose every 6 weeks for up to 6 doses. In this trial, researchers want to see if treatment following the first two doses of lutetium 177 Lu PSMA RLT can be delayed until there is evidence of disease activity. This may be an effective way to improve quality of life without decreasing lifespan in patients with advanced prostate cancer.

Interventions

  • Lutetium Lu 177 Vipivotide Tetraxetan (Drug)
    Given IV
  • Biospecimen Collection (Procedure)
    Undergo blood sample collection
  • Patient Monitoring (Procedure)
    Undergo PSA monitoring
  • Computed Tomography (Procedure)
    Undergo CT
  • Bone Scan (Procedure)
    Undergo Bone Scan
  • PSMA PET Scan (Procedure)
    Undergo PSMA PET Scan
  • MRI (Procedure)
    Undergo MRI
  • Questionnaire Administration (Other)
    Ancillary studies

Eligibility criteria

Inclusion Criteria: * PRE-REGISTRATION (STEP 0): Patients must have histological, pathological, and/or cytological confirmation of prostate adenocarcinoma * PRE-REGISTRATION (STEP 0): Patients must have a positive PSMA PET/CT scan (either gallium Ga 68 gozetotide \[68Ga-PSMA-11\], fluorine F 18 piflufolastat \[18F- DCFPyl\], or fluorine F 18 flotufolastat gallium \[18F-rhPSMA-7.3\]), as defined as uptake greater than liver with no PSMA negative measurable soft tissue disease * PRE-REGISTRATION (STEP 0): PSA greater than 2.0 ng/mL * PRE-REGISTRATION (STEP 0): Patients must have progressive mCRPC. Documented progressive mCRPC will be based on at least 1 of the following criteria: * Serum PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 ng/mL * Soft-tissue progression defined as an increase ≥ 20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or more new lesions * Progression of bone disease: evaluable disease or new bone lesions(s) by bone scan (2+2 Prostate Cancer Clinical Trials Working Group 3 \[PCWG3\] criteria, Scher et al 2016) * PRE-REGISTRATION (STEP 0): Patients must have prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (\< 50 ng/dL or \< 1.7 nmol/L) * PRE-REGISTRATION (STEP 0): Patients must have received at least one androgen receptor pathway inhibitor (ARPI) (to include either apalutamide, darolutamide, enzalutamide, or abiraterone) \* ARPI must be stopped at least 4 weeks prior to pre-registration * PRE-REGISTRATION (STEP 0): Patients must not have previously received a taxane based chemotherapy regimen for mCRPC. Prior docetaxel for metastatic hormone-sensitive prostate carcinoma (mHSPC) or in the neoadjuvant or adjuvant setting is permitted if completed at least 12 months prior to pre-registration * PRE-REGISTRATION (STEP 0): Patients must have recovered to ≤ grade 2 from all clinically significant toxicities related to prior therapies (i.e. prior chemotherapy, radiation, immunotherapy, etc.) * PRE-REGISTRATION (STEP 0): Patients on a stable bisphosphonate or denosumab regimen for ≥ 30 days prior to pre-registration are eligible * PRE-REGISTRATION (STEP 0): Previous treatment with strontium Sr-89 (strontium-89), samarium Sm-153 (samarium-153), rhenium Re 186 (rhenium-186), rhenium Re 188 (rhenium-188), radium Ra 223 (radium-223) or hemi-body irradiation within 6 months prior to pre-registration is not allowed. Previous PSMA-targeted radioligand therapy is not allowed * PRE-REGISTRATION (STEP 0): Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy \[including monoclonal antibodies\]) within 28 days prior to pre-registration is not allowed * PRE-REGISTRATION (STEP 0): Age ≥ 18 years * PRE-REGISTRATION (STEP 0): Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 * PRE-REGISTRATION (STEP 0): Absolute neutrophil count (ANC) ≥ 1,500/mm\^3 * PRE-REGISTRATION (STEP 0): Platelet count ≥ 100,000/mm\^3 * PRE-REGISTRATION (STEP 0): Total bilirubin \< 1.5 x upper limit of normal (ULN) or \< 3 x ULN in patients with Gilbert's syndrome * PRE-REGISTRATION (STEP 0): Creatinine clearance estimated glomerular filtration rate (eGFR) ≥ 40 mL/min/1.73m\^2 using the Modification of Diet in Renal Disease (MDRD) equation * PRE-REGISTRATION (STEP 0): No acute biliary or urinary obstruction * PRE-REGISTRATION (STEP 0): Patients with treated/stable brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression \* Patients with a history of CNS metastases must have received therapy (surgery, radiotherapy, gamma knife) and be neurologically stable, asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity. Patients with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired. For patients with parenchymal CNS metastasis (or a history of CNS metastasis), baseline and subsequent radiological imaging must include evaluation of the brain (MRI preferred or CT with contrast) * PRE-REGISTRATION (STEP 0): Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial * PRE-REGISTRATION (STEP 0): For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * PRE-REGISTRATION (STEP 0): Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * PRE-REGISTRATION (STEP 0): Patients with 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. To be eligible for this trial, patients should be class II or better * PRE-REGISTRATION (STEP 0): No investigational agents within 28 days prior to pre-registration * PRE-REGISTRATION (STEP 0): No other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy * PRE-REGISTRATION (STEP 0): No known hypersensitivity to the components of the study therapy or its analogs * PRE-REGISTRATION (STEP 0): No transfusion within 30 days of pre-registration * PRE-REGISTRATION (STEP 0): No symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression * PRE-REGISTRATION (STEP 0): Ability to read and comprehend English or Spanish * REGISTRATION (STEP 1): Completion of 2 doses of 177Lu PSMA RLT * REGISTRATION (STEP 1): PSA decline ≥ 50% between C1 D1 (screening) and C2 D22 +/-3 days * REGISTRATION (STEP 1): ECOG Performance Status ≤ 2 * REGISTRATION (STEP 1): Absolute neutrophil count (ANC) ≥ 1,500/mm\^3 * REGISTRATION (STEP 1): Platelet count ≥ 100,000/mm\^3 * REGISTRATION (STEP 1): Creatinine clearance eGFR ≥ 40 mL/min/1.73m\^2 using the Modification of Diet in Renal Disease (MDRD) equation

Conditions

Metastatic Castration-Resistant Prostate Carcinoma Metastatic Prostate Adenocarcinoma Stage IVB Prostate Cancer AJCC v8

Locations

  • Providence Alaska Medical Center — Anchorage, Alaska, United States
  • AIS Cancer Center at San Joaquin Community Hospital — Bakersfield, California, United States
  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California, United States
  • City of Hope at Irvine Lennar — Irvine, California, United States
  • UC San Diego Moores Cancer Center — La Jolla, California, United States
  • Cedars-Sinai Medical Center — Los Angeles, California, United States
  • UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States
  • University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
  • UC San Diego Medical Center - Hillcrest — San Diego, California, United States
  • UCHealth University of Colorado Hospital — Aurora, Colorado, United States
  • UCHealth Memorial Hospital Central — Colorado Springs, Colorado, United States
  • Memorial Hospital North — Colorado Springs, Colorado, United States
  • Helen F Graham Cancer Center — Newark, Delaware, United States
  • Medical Oncology Hematology Consultants PA — Newark, Delaware, United States
  • CTCA at Southeastern Regional Medical Center — Newnan, Georgia, United States
  • Kootenai Health - Coeur d'Alene — Coeur d'Alene, Idaho, United States
  • Kootenai Clinic Cancer Services - Post Falls — Post Falls, Idaho, United States
  • Kootenai Clinic Cancer Services - Sandpoint — Sandpoint, Idaho, United States
  • Northwestern University — Chicago, Illinois, United States
  • Cancer Care Specialists of Illinois - Decatur — Decatur, Illinois, United States
  • Decatur Memorial Hospital — Decatur, Illinois, United States
  • Northwestern Medicine Cancer Center Kishwaukee — DeKalb, Illinois, United States
  • Northwestern Medicine Cancer Center Delnor — Geneva, Illinois, United States
  • SSM Health Good Samaritan — Mount Vernon, Illinois, United States
  • Cancer Care Center of O'Fallon — O'Fallon, Illinois, United States
  • HSHS Saint Elizabeth's Hospital — O'Fallon, Illinois, United States
  • Northwestern Medicine Oak Brook — Oak Brook, Illinois, United States
  • Northwestern Medicine Cancer Center Warrenville — Warrenville, Illinois, United States
  • Midwestern Regional Medical Center — Zion, Illinois, United States
  • Mary Greeley Medical Center — Ames, Iowa, United States
  • McFarland Clinic - Ames — Ames, Iowa, United States
  • UI Health Care Mission Cancer and Blood - Ankeny Clinic — Ankeny, Iowa, United States
  • McFarland Clinic - Boone — Boone, Iowa, United States
  • Saint Anthony Regional Hospital — Carroll, Iowa, United States
  • UI Health Care Mission Cancer and Blood - West Des Moines Clinic — Clive, Iowa, United States
  • Iowa Methodist Medical Center — Des Moines, Iowa, United States
  • UI Health Care Mission Cancer and Blood - Des Moines Clinic — Des Moines, Iowa, United States
  • Broadlawns Medical Center — Des Moines, Iowa, United States
  • UI Health Care Mission Cancer and Blood - Laurel Clinic — Des Moines, Iowa, United States
  • McFarland Clinic - Trinity Cancer Center — Fort Dodge, Iowa, United States
  • UI Healthcare Mission Cancer and Blood - Fort Dodge — Fort Dodge, Iowa, United States
  • McFarland Clinic - Jefferson — Jefferson, Iowa, United States
  • McFarland Clinic - Marshalltown — Marshalltown, Iowa, United States
  • UI Healthcare Mission Cancer and Blood - Pella — Pella, Iowa, United States
  • UI Health Care Mission Cancer and Blood - Waukee Clinic — Waukee, Iowa, United States
  • The Iowa Clinic PC — West Des Moines, Iowa, United States
  • Maryland Proton Treatment Center — Baltimore, Maryland, United States
  • University of Maryland/Greenebaum Cancer Center — Baltimore, Maryland, United States
  • UM Upper Chesapeake Medical Center — Bel Air, Maryland, United States
  • Central Maryland Radiation Oncology in Howard County — Columbia, Maryland, United States
  • University of Maryland Shore Medical Center at Easton — Easton, Maryland, United States
  • UM Baltimore Washington Medical Center/Tate Cancer Center — Glen Burnie, Maryland, United States
  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor — Ann Arbor, Michigan, United States
  • Bronson Battle Creek — Battle Creek, Michigan, United States
  • Henry Ford Cancer Institute-Downriver — Brownstown, Michigan, United States
  • Henry Ford Macomb Hospital-Clinton Township — Clinton Township, Michigan, United States
  • Henry Ford Medical Center-Fairlane — Dearborn, Michigan, United States
  • Henry Ford Hospital — Detroit, Michigan, United States
  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital — Grand Rapids, Michigan, United States
  • Allegiance Health — Jackson, Michigan, United States
  • Bronson Methodist Hospital — Kalamazoo, Michigan, United States
  • West Michigan Cancer Center — Kalamazoo, Michigan, United States
  • Corewell Health Lakeland Hospitals - Niles Hospital — Niles, Michigan, United States
  • Henry Ford Medical Center-Columbus — Novi, Michigan, United States
  • Trinity Health Saint Joseph Mercy Oakland Hospital — Pontiac, Michigan, United States
  • Corewell Health Reed City Hospital — Reed City, Michigan, United States
  • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center — Saint Joseph, Michigan, United States
  • Corewell Health Lakeland Hospitals - Saint Joseph Hospital — Saint Joseph, Michigan, United States
  • Munson Medical Center — Traverse City, Michigan, United States
  • Henry Ford West Bloomfield Hospital — West Bloomfield, Michigan, United States
  • Henry Ford Wyandotte Hospital — Wyandotte, Michigan, United States
  • University of Michigan Health - West — Wyoming, Michigan, United States
  • Minnesota Oncology - Burnsville — Burnsville, Minnesota, United States
  • Cambridge Medical Center — Cambridge, Minnesota, United States
  • Mercy Hospital — Coon Rapids, Minnesota, United States
  • Fairview Southdale Hospital — Edina, Minnesota, United States
  • Fairview Clinics and Surgery Center Maple Grove — Maple Grove, Minnesota, United States
  • Minnesota Oncology Hematology PA-Maplewood — Maplewood, Minnesota, United States
  • Saint John's Hospital - Healtheast — Maplewood, Minnesota, United States
  • Abbott-Northwestern Hospital — Minneapolis, Minnesota, United States
  • Hennepin County Medical Center — Minneapolis, Minnesota, United States
  • New Ulm Medical Center — New Ulm, Minnesota, United States
  • Fairview Northland Medical Center — Princeton, Minnesota, United States
  • North Memorial Medical Health Center — Robbinsdale, Minnesota, United States
  • Coborn Cancer Center at Saint Cloud Hospital — Saint Cloud, Minnesota, United States
  • Park Nicollet Clinic - Saint Louis Park — Saint Louis Park, Minnesota, United States
  • Regions Hospital — Saint Paul, Minnesota, United States
  • United Hospital — Saint Paul, Minnesota, United States
  • Saint Francis Regional Medical Center — Shakopee, Minnesota, United States
  • Lakeview Hospital — Stillwater, Minnesota, United States
  • Ridgeview Medical Center — Waconia, Minnesota, United States
  • Rice Memorial Hospital — Willmar, Minnesota, United States
  • Minnesota Oncology Hematology PA-Woodbury — Woodbury, Minnesota, United States
  • Fairview Lakes Medical Center — Wyoming, Minnesota, United States
  • Heartland Regional Medical Center — Saint Joseph, Missouri, United States
  • Missouri Baptist Medical Center — St Louis, Missouri, United States
  • Community Hospital of Anaconda — Anaconda, Montana, United States
  • Billings Clinic Cancer Center — Billings, Montana, United States
  • Bozeman Health Deaconess Hospital — Bozeman, Montana, United States
  • Benefis Sletten Cancer Institute — Great Falls, Montana, United States
  • Great Falls Clinic — Great Falls, Montana, United States
  • Hi-Line Sletten Cancer Center — Havre, Montana, United States
  • Benefis Helena Specialty Center — Helena, Montana, United States
  • Logan Health Medical Center — Kalispell, Montana, United States
  • Community Medical Center — Missoula, Montana, United States
  • Memorial Sloan Kettering Basking Ridge — Basking Ridge, New Jersey, United States
  • AtlantiCare Health Park-Cape May Court House — Cape May Court House, New Jersey, United States
  • AtlantiCare Surgery Center — Egg Harbor, New Jersey, United States
  • Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States
  • Memorial Sloan Kettering Bergen — Montvale, New Jersey, United States
  • Capital Health Medical Center-Hopewell — Pennington, New Jersey, United States
  • Roswell Park Cancer Institute — Buffalo, New York, United States
  • Memorial Sloan Kettering Commack — Commack, New York, United States
  • Memorial Sloan Kettering Westchester — Harrison, New York, United States
  • Memorial Sloan Kettering Cancer Center — New York, New York, United States
  • Montefiore Medical Center-Einstein Campus — The Bronx, New York, United States
  • Montefiore Medical Center - Moses Campus — The Bronx, New York, United States
  • Memorial Sloan Kettering Nassau — Uniondale, New York, United States
  • Sanford Bismarck Medical Center — Bismarck, North Dakota, United States
  • Sanford Broadway Medical Center — Fargo, North Dakota, United States
  • Sanford Roger Maris Cancer Center — Fargo, North Dakota, United States
  • MetroHealth Medical Center — Cleveland, Ohio, United States
  • University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
  • Providence Portland Medical Center — Portland, Oregon, United States
  • Providence Saint Vincent Medical Center — Portland, Oregon, United States
  • Sanford Cancer Center Oncology Clinic — Sioux Falls, South Dakota, United States
  • Sanford USD Medical Center - Sioux Falls — Sioux Falls, South Dakota, United States
  • Covenant Medical Center-Lakeside — Lubbock, Texas, United States
  • Swedish Cancer Institute-Edmonds — Edmonds, Washington, United States
  • Swedish Medical Center-First Hill — Seattle, Washington, United States
  • Froedtert Menomonee Falls Hospital — Menomonee Falls, Wisconsin, United States
  • Medical College of Wisconsin — Milwaukee, Wisconsin, United States
  • Froedtert and MCW Moorland Reserve Health Center — New Berlin, Wisconsin, United States
  • Cancer Center of Western Wisconsin — New Richmond, Wisconsin, United States
  • Drexel Town Square Health Center — Oak Creek, Wisconsin, United States
  • Froedtert West Bend Hospital/Kraemer Cancer Center — West Bend, Wisconsin, United States
  • Memorial Hospital of Laramie County — Cheyenne, Wyoming, United States
  • Billings Clinic-Cody — Cody, Wyoming, United States
Sponsored

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record