Recruiting PHASE3 Metastatic Castration-Resistant Prostate Carcinoma

New treatment option for Metastatic Castration-Resistant Prostate Carcinoma

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

ClinicalTrials.gov ID: NCT07200830

What this study is testing

What is Lutetium Lu 177 Vipivotide Tetraxetan?

Lutetium Lu 177 Vipivotide Tetraxetan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic castration-resistant prostate carcinoma.

Also referred to as Pluvicto.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 3: a large, late-stage study
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older, men only

You may be able to join if

  • 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...
  • 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...
See the full eligibility criteria
Who can join
  • 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...
  • 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...
  • 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...
  • 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...
  • 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...
  • 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...
  • 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...
  • 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...
  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • Anchorage, Alaska, United States
  • Bakersfield, California, United States
  • Irvine, California, United States
  • Orange, California, United States
  • Sacramento, California, United States
  • Newark, Delaware, United States
  • Newnan, Georgia, United States
  • Coeur d'Alene, Idaho, United States
  • Post Falls, Idaho, United States
  • Sandpoint, Idaho, United States
  • Chicago, Illinois, United States
  • Decatur, Illinois, United States
  • O'Fallon, Illinois, United States
  • Warrenville, Illinois, United States
  • Zion, Illinois, United States
  • Ames, Iowa, United States
  • Ankeny, Iowa, United States
  • Boone, Iowa, United States
  • Carroll, Iowa, United States
  • Clive, Iowa, United States

+ 65 more site(s).

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Anchorage, Alaska, United States; Bakersfield, California, United States; Irvine, California, United States; Orange, California, United States; Sacramento, California, United States; Newark, Delaware, United States and 79 more location(s). Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.