RecruitingPhase 3

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

Radioligand Efficacy Comparison by Initial PSA-Response Outcome in Metastatic CRPC With Lutetium 177Lu PSMA RLT (RECIPROCAL)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 years
  • Procedures mentioned: Blood draws, CT scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "ARM 2: Starting cycle 2 day 42, patients undergo blood sample collection and PSA monitoring once every 3 weeks (Q3W) in the absence of disease progression or unacceptable toxicity."
  • "Additionally, all patients undergo blood sample collection, computed tomography (CT), and bone scan throughout the trial and PSMA positron emission tomography (PET) during screening."
  • "After completion of study treatment, patients are followed up every 12 weeks until disease progression and then every 6 months thereafter for 5 years following registration."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether waiting longer between doses of lutetium 177Lu PSMA RLT can improve quality of life without shortening life. This drug delivers radiation to prostate cancer cells. The study is for adults with prostate cancer that has spread and is getting worse despite treatment to lower male hormones.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and able to read and understand English or Spanish.
  • Have prostate adenocarcinoma, a type of prostate cancer, confirmed by a tissue or cell test.
  • Have cancer that has spread and is getting worse despite very low testosterone, a male hormone. PSA, a blood marker for prostate cancer, must be above 2.0 ng/mL.
  • Have a qualifying PSMA PET/CT scan showing the drug's target protein on cancer cells.
  • Have had surgery to remove the testicles and/or be taking hormone-lowering treatment. Have used at least one listed hormone-blocking drug and stopped it at least 4 weeks before signing up.
  • Be able to care for yourself and be out of bed or a chair for at least half the day. Blood counts, kidney function, and liver tests must meet study limits.
  • Have recovered from major side effects of past treatment to a moderate level or less. HIV or hepatitis, if present, must meet the study's treatment and virus-control rules.
  • For the next study step, finish 2 doses of the study drug and have PSA drop by at least 50% by the required check. Blood counts, kidney function, and daily activity must still meet study limits.

Who can't join

  • Past taxane chemotherapy for cancer that resists hormone treatment. Earlier docetaxel use is allowed only in the listed settings and if finished at least 12 months before signing up.
  • Any past PSMA-targeted radiation drug treatment, or certain other radiation drugs or radiation to half the body within 6 months.
  • Cancer drugs that treat the whole body or experimental drugs within 28 days before signing up. Certain other cancer treatments are also not allowed during the study.
  • A blood transfusion within 30 days before signing up, or a known allergy to the study drug's ingredients or similar drugs.
  • A sudden blockage of bile or urine flow.
  • Pressure on the spinal cord that causes symptoms, or signs that this may happen soon.
  • Cancer in the brain or around the spinal cord that does not meet treatment and stability rules. Brain spread must be treated and stable, without symptoms or steroids needed to support nerve function.
  • Heart disease that causes more than mild limits on physical activity, based on the required heart check.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (138)

AK

CA

CO

DE

GA

  • CTCA at Southeastern Regional Medical Center · Newnan, GA 30265Site Public Contact · Study contact · 770-400-6629Bamidele A. Adesunloye · Principal investigatorMore trials in Newnan

IA

ID

IL

MD

MI

MN

MO

MT

ND

NJ

NY

OH

OK

OR

SD

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WA

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WY