RECIPROCAL Trial: Lutetium 177Lu PSMA RLT for Advanced Prostate Cancer
This study, called the RECIPROCAL trial, is testing different ways to give the anti-cancer drug Lutetium 177Lu PSMA RLT to men with advanced prostate cancer that has spread and is resistant to hormone therapy. This type of prostate cancer often has a protein called PSMA on the surface of its cells. Lutetium 177Lu PSMA RLT works by attaching to this PSMA protein on the cancer cells. The study wants to see if giving the drug less often, based on your PSA levels, can improve your quality of life without shortening your lifespan, compared to the standard every-six-week schedule. We will be looking at how long you live (overall survival) and your quality of life. You must have a positive PSMA PET/CT scan to join.
- Study design
- This is a randomized study comparing two different dosing schedules of Lutetium 177Lu PSMA RLT. It plans to include 1524 men.
- What's involved
- You would receive Lutetium 177Lu PSMA RLT intravenously (IV), have blood samples taken, and undergo PSA monitoring, CT scans, and bone scans. The study measures overall survival for up to 5 years and quality of life for up to 30 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your overall survival will be monitored for up to 5 years, and your quality of life will be assessed for up to 30 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07200830
Testing Different Dosing Schedules of the Anti-cancer Drug, Lutetium 177Lu PSMA RLT and Its Effect on Patients With Advanced Prostate Cancer, RECIPROCAL Trial
Recruiting
PHASE3Ages 18+InterventionalTreatmentAlliance for Clinical Trials in OncologyInvestigator-initiated
~1,524 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:Lutetium Lu 177 Vipivotide TetraxetanBiospecimen CollectionPatient MonitoringComputed TomographyBone ScanPSMA PET Scan
At a glance
Recruiting sites
73 of 112 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall survival (OS)
Measured over Up to 5 years
+1 more outcome measured
Conditions
Where it's being run
112 sites across 21 statesMinnesota22
Iowa17
Michigan10
Montana9
Illinois8
New York7
New Jersey6
Wisconsin6
Study leadership
- Thomas Hope, MD · STUDY_CHAIR · Alliance for Clinical Trials in Oncology
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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)
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
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
What this trial measures
- Overall survival (OS)Up to 5 years
Will be calculated as time from randomization until death due to any cause, censoring patients not known to have died at the time of their last follow-up. OS will be compared between the treatment arms using a stratified log rank test
- Quality of lifeUp to 30 months
Will be measured using the Functional Assessment of Cancer Therapy- Prostate (FACT-P) total scores. A repeated measures mixed model will be used to evaluate the between-arm mean difference in FACT-P Total scores across the first 30 months from treatment start. A point estimate of the difference and 95% confidence interval will be reported. Results of formal hypothesis testing will only be reported if adaptive dosing is deemed noninferior to standard dosing with regards to overall survival.