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Metastatic Prostate CancerPhase 1/2LUNAARNCT06329830

177Lu-PSMA, Niraparib/AA Plus Prednisone for Prostate Cancer

A Phase 1/2 study testing 177Lu-PSMA-617, Niraparib abiraterone acetate and Prednisone in people with Metastatic Prostate Cancer and Castration-resistant Prostate Cancer, run by Baptist Health South Florida at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

The purpose of this research study is to test the safety and possible side effects of Lutetium-177 (177Lu)-Prostate-Specific Membrane Antigen (PSMA)-617 along with niraparib and abiraterone acetate plus prednisone when it is given to people diagnosed with metastatic castration-resistant prostate cancer (prostate… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
177Lu-PSMA-617, Niraparib abiraterone acetate and Prednisone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Oct 2024to Oct 2028
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent must be obtained prior to participation in the study
  • Adults ≥ 18 years of age
  • Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2
  • Life expectancy of greater than six months as determined by the treating physician
  • Evidence of metastatic castration resistant prostate cancer with histological or cytology confirmed adenocarcinoma. This can be based on prior biopsy of prostate or metastatic disease.
  • Should have previous therapy with at least one androgen receptor pathway inhibitor in castration resistant or sensitive setting, and
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  • Should have prior therapy with at least one line of therapy with taxane chemotherapy in castration resistant or sensitive setting
  • Evidence of disease progression on current therapy which is based on either:
  • PSA progression: based on rising values at a minimum of 1-week intervals. The minimum starting value of PSA being 1 ng/mL
  • Radiologic progression: growth of known metastases or evidence of new metastases.
  • Evidence of PSMA positive disease based on PSMA positron emission tomography (PET)/computed tomography (CT) scan utilizing radiotracers F-18 piflufolastat PSMA or Ga-68 PSMA-11. PSMA positive is defined as having at least one tumor lesion with radiotracer uptake greater than normal liver. Patients will be excluded if any lesions exceeding size criteria in short axis [organs ≥ 1 cm, lymph nodes ≥ 2.5 cm, bones (soft tissue component) ≥ 1 cm] have uptake less than or equal to uptake in normal liver.
  • Patients must have evidence of metastatic disease with at least one of the following:
  • Metastatic disease in the bones visible on technetium-99m-MDP (methylene diphosphonate) bone scan ("bone scan") and/or
  • Pathologically enlarged lymph nodes of any distribution and/or
  • Visceral metastasis of any size or distribution.
  • Adequate organ function:
  • Bone marrow reserve: absolute neutrophil count (ANC) ≥ 1500 cells/microliter (uL), platelets ≥ 100,000 cells/uL, hemoglobin ≥ 9 g/dL
  • Hepatic function: total bilirubin ≤ 2 × institutional upper limit of normal (ULN), for patients with known Gilbert syndrome ≤ 3 × institutional ULN is permitted. Alanine transaminase (ALT) or aspartate transaminase (AST) ≤ 3 × institutional ULN or ≤ 5 × institutional ULN if liver metastases
  • Renal function: estimated glomerular filtration rate (eGFR) ≥ 45 mL/min
  • Able to swallow the study medication tablets whole.
  • While on study medication and for 4 months following the last dose of study medication, participants must agree to use condom and an adequate contraception method for partner of childbearing potential. Participants must agree not to donate sperm while on study treatment and for a minimum of 4 months following the last dose of study medication.

Who cannot join

  • Pathological finding consistent with small cell or neuroendocrine carcinoma of the prostate
  • Prior therapy with poly adenosine diphosphate (ADP)-ribose polymerase (PARP) inhibitor
  • Prior therapy with 177Lu-PSMA 617 therapy. Exception: prior therapy with radium 223 is allowed if last dose was ≥ 6 months from study therapy. Note that other prior radiation therapy (such as external beam radiation therapy or brachytherapy) to prostate or other metastatic sites is allowed.
  • History of adrenal dysfunction
  • Active malignancies (i.e., progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. The only allowed exceptions are:
  • Non-muscle invasive bladder cancer
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  • Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured
  • Malignancy that is considered cured with minimal risk of recurrence
  • History or current diagnosis of myelodysplastic syndrome/acute myeloid leukemia (MDS/AML)
  • Current evidence within 3 months of study consent of any of the following: severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, clinically significant arterial or venous thromboembolic events (i.e., pulmonary embolism), or clinically significant ventricular arrhythmias.
  • Presence of sustained uncontrolled hypertension (systolic blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg). Participants with a history of hypertension are allowed, provided that blood pressure is controlled to within these limits by an antihypertensive treatment.
  • Known allergies, hypersensitivity, or intolerance to the excipients of Nira/AA tablets.
  • Current evidence of any medical condition that would make prednisone use contraindicated.
  • Received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 30 days before the planned first dose of study medication
  • Participants who have had the following ≤ 28 days prior to enrollment
  • A transfusion (platelets or red blood cells);
  • Hematopoietic growth factors;
  • Major surgery
  • Participants with known history of human immunodeficiency virus with 1 or more of the following:
  • Not receiving highly active antiretroviral therapy or on antiretroviral therapy for less than 4 weeks
  • Receiving antiretroviral therapy that may interfere with the study medication
  • CD4 (type of white blood cell) count <350 at screening.
  • An acquired immunodeficiency syndrome-defining opportunistic infection within 6 months of the start of screening.
  • Human immunodeficiency virus load >400 copies/mL
  • Known history of active or symptomatic viral hepatitis or chronic liver disease; encephalopathy, ascites or bleeding disorders secondary to hepatic dysfunction.
  • Moderate or severe hepatic impairment (Class B and C per Child-Pugh classification system).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Miami Cancer Institute

    Miami, Florida, 33176

Other trials in United States

About this study

Official title: Safety and Anti-tumor Activity of Lutetium-177 (177Lu)-PSMA-617 Along With Niraparib and Abiraterone Acetate Plus Prednisone in Metastatic Castration Resistant Prostate Cancer - LUNAAR Study

The purpose of this research study is to test the safety and possible side effects of Lutetium-177 (177Lu)-Prostate-Specific Membrane Antigen (PSMA)-617 along with niraparib and abiraterone acetate plus prednisone when it is given to people diagnosed with metastatic castration-resistant prostate cancer (prostate cancer that has spread to other parts of the body and does not improve with hormonal therapies) at different dose levels. Once an optimal dose is selected, the researchers want to find out what how well these treatments work to improve survival and control the growth of the tumor.

Being tested
177Lu-PSMA-617, Niraparib abiraterone acetate, Prednisone
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 177Lu-PSMA-617Drug

    Also called Pluvicto

    7.4 GBq (200 mCi) via IV infusion once every 6 weeks for 6 cycles

  • Niraparib abiraterone acetateDrug

    Also called Akeega

    Dual action drug tablet that is taken orally by the participant once per day in one of the following dose combinations depending on the cohort assignment and number of dose-limiting toxicities: 200 mg/1000 mg, 150 mg/1000 mg, 100 mg/1000 mg, 50 mg/500 mg

  • PrednisoneDrug

    Also called Rayos, Prednisone Intensol, Deltasone

    5 mg orally twice per day

Study groups in NCT06329830
Study groupRoleWhat they receive
177Lu-PSMA-617 in Combination with Niraparib/Abiraterone Acetate plus PrednisoneExperimental177Lu-PSMA-617 will be administered per standard of care at 7.4 gigabecquerel (GBq) (200 mCi) via intravenous (IV) infusion once every cycle (6 weeks) for 6 cycles. Niraparib/Abiraterone Acetate (Nira/AA) will be taken orally by the participant daily until disease progression or unacceptable toxicity. The starting dose level is 150 mg/1000 mg Nira/AA. Other dose levels include 200 mg/1000 mg, 100 mg/1000 mg, or 50 mg/500 mg Nira/AA once daily. Prednisone (5 mg) will be taken orally by the participant twice daily each day that Nira/AA is taken.
Receives: Drug: 177Lu-PSMA-617; Drug: Niraparib abiraterone acetate; Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determination of the recommended phase 2 dose (RP2D)

    RP2D is determined based on the number of participants experiencing a dose-limiting toxicity (DLT) during phase 1. DLT is defined as any of the following treatment-related adverse events (AE) during Cycle 1, per Common Terminology Criteria for Adverse Events (CTCAE) V5.

    • Grade 4 thrombocytopenia or Grade ≥3 requiring platelet transfusion
    • Grade 4 anemia or Grade ≥3 requiring blood transfusion
    • Grade 4 neutropenia ≥7 days, or Grade 3/4 associated with infection or fever >38.5°C
    • Seizure, any grade
    • Concurrent elevation of ALT/AST >3×ULN \& bilirubin >2×ULN, unless concurrent elevation is related to biliary obstruction or otherwise unrelated to study treatment
    • Grade 3 fatigue >5 days
    • Grade 3 nausea >3 days, despite optimal medical therapy
    • Grade ≥3 hypertension despite receiving >2 weeks of optimal medical therapy
    • Grade ≥3 vomiting or diarrhea persisting >3 days, despite optimal medical therapy
    • Other treatment-related Grade ≥3 non-hematologic toxicity except Grade 3 rash

    Measured: 6 weeks

  2. Prostatic-specific antigen (PSA)-50 response rate

    PSA-50 response is defined as a decrease ≥ 50% from baseline to the lowest post-baseline PSA result. This measure will be expressed as a percent of participants who experience this response.

    Measured: 2 years

Secondary outcomes (5)

  1. Radiographic progression-free survival (rPFS)

    rPFS is defined as the duration of time in months from treatment initiation to the first date of documented radiographic progression using conventional imaging or death due to any cause, whichever occurs first. The radiographic progression will be assessed per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 for soft tissue and Prostate Cancer Working Group 3 (PCWG3) for bone lesions.

    Measured: 2 years

  2. Overall survival (OS)

    OS is defined as the duration of time in months between the first dose of study therapy and death from any cause (participants who have not died will be censored at the most recent last-known-alive date).

    Measured: 2 years

  3. PSA-80 response rate

    PSA-80 response is defined as a decrease ≥ 80% from baseline to the lowest post-baseline PSA result. This measure will be expressed as a percent of participants who experience this response.

    Measured: 2 years

  4. Duration of response (DOR)

    DOR is defined as the duration of time in months from when criteria are met for complete response (CR) or partial response (PR) (whichever is recorded first) until the date that recurrent or progressive disease is objectively documented or expiration. RECIST 1.1 criteria will be used for soft tissue lesions and PCWG3 criteria will be used for bone lesions.

    Measured: 2 years

  5. Objective response rate (ORR)

    ORR is defined as the percent of participants who meet criteria for CR or PR. RECIST 1.1 criteria will be used for soft tissue lesions and PCWG3 criteria will be used for bone lesions.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2024
  2. Study startOct 2024 (estimated)
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 2028 (estimated)

Why it stopped: Funding for the study was withdrawn.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06329830
Sponsor's protocol ID
2023-GAR-001
Acronym
LUNAAR
Status last verified
Sep 2024
First submitted
19 Mar 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Loap P, Loirat D, Berger F, Rodrigues M, Bazire L, Pierga JY, Vincent-Salomon A, Laki F, Boudali L, Raizonville L, Mosseri V, Jochem A, Eeckhoutte A, Diallo M, Stern MH, Fourquet A, Kirova Y. Concurrent Olaparib and Radiotherapy in Patients With Triple-Negative Breast Cancer: The Phase 1 Olaparib and Radiation Therapy for Triple-Negative Breast Cancer Trial. JAMA Oncol. 2022 Dec 1;8(12):1802-1808. doi: 10.1001/jamaoncol.2022.5074.

    PubMed 36301572

  • Sandhu S, Joshua AM, Emmett L, Crumbaker M, Bressel M, Huynh R, Banks PD, Wallace R, Hamid A, Inderjeeth AJ, Tran B, Azad A, Alipour R, Kong G, Kumar AAR, Saghebi J, Williams S, Akhurst TJ, Kicks RJ, Hofman MS. LuPARP: Phase 1 trial of 177Lu-PSMA-617 and olaparib in patients with metastatic castration resistant prostate cancer (mCRPC). J Clin Oncol 2023 41(16Suppl):5005.

  • Smith MR, Scher HI, Sandhu S, Efstathiou E, Lara PN Jr, Yu EY, George DJ, Chi KN, Saad F, Stahl O, Olmos D, Danila DC, Mason GE, Espina BM, Zhao X, Urtishak KA, Francis P, Lopez-Gitlitz A, Fizazi K; GALAHAD investigators. Niraparib in patients with metastatic castration-resistant prostate cancer and DNA repair gene defects (GALAHAD): a multicentre, open-label, phase 2 trial. Lancet Oncol. 2022 Mar;23(3):362-373. doi: 10.1016/S1470-2045(21)00757-9. Epub 2022 Feb 4.

    PubMed 35131040

  • Chi KN, Rathkopf D, Smith MR, Efstathiou E, Attard G, Olmos D, Lee JY, Small EJ, Pereira de Santana Gomes AJ, Roubaud G, Saad M, Zurawski B, Sakalo V, Mason GE, Francis P, Wang G, Wu D, Diorio B, Lopez-Gitlitz A, Sandhu S; MAGNITUDE Principal Investigators. Niraparib and Abiraterone Acetate for Metastatic Castration-Resistant Prostate Cancer. J Clin Oncol. 2023 Jun 20;41(18):3339-3351. doi: 10.1200/JCO.22.01649. Epub 2023 Mar 23.

    PubMed 36952634

  • Sartor O, de Bono J, Chi KN, Fizazi K, Herrmann K, Rahbar K, Tagawa ST, Nordquist LT, Vaishampayan N, El-Haddad G, Park CH, Beer TM, Armour A, Perez-Contreras WJ, DeSilvio M, Kpamegan E, Gericke G, Messmann RA, Morris MJ, Krause BJ; VISION Investigators. Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2021 Sep 16;385(12):1091-1103. doi: 10.1056/NEJMoa2107322. Epub 2021 Jun 23.

    PubMed 34161051

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 177Lu-PSMA-617, Niraparib abiraterone acetate and Prednisone in people with Metastatic Prostate Cancer and Castration-resistant Prostate Cancer, run by Baptist Health South Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determination of the recommended phase 2 dose (RP2D) (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06329830, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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