Loading clinical trials...

177Lu-PSMA, Niraparib/AA Plus Prednisone for Prostate Cancer | Clinical Trials | Clareo Health

WITHDRAWNPHASE1/PHASE2

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

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

NCT06329830•Baptist Health South Florida

View on ClinicalTrials.gov

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 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.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•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.
•1. Should have previous therapy with at least one androgen receptor pathway inhibitor in castration resistant or sensitive setting, and
•2. 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:
•1. PSA progression: based on rising values at a minimum of 1-week intervals. The minimum starting value of PSA being 1 ng/mL
•2. Radiologic progression: growth of known metastases or evidence of new metastases.
+11 more criteria

Exclusion Criteria

•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:
•1. Non-muscle invasive bladder cancer
•2. Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured
•3. 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.
+16 more criteria

Locations (1)

Miami Cancer Institute

Miami, Florida, United States

Key Dates

Start Date

October 1, 2024

Primary Completion Date

October 1, 2026

Completion Date

October 1, 2028

Last Updated

September 19, 2024

Conditions

Metastatic Prostate CancerCastration-resistant Prostate CancerMetastatic Castration-resistant Prostate Cancer

Interventions

177Lu-PSMA-617

DRUG

Niraparib abiraterone acetate

DRUG

Prednisone

DRUG

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06842498

Metastatic Castration-Resistant Prostate Cancer

View study

RECRUITINGPHASE2

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

NCT05489211

Endometrial CancerGastric Cancer+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC

A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)

Study of AZD0516 as Monotherapy and in Combination in Participants With Metastatic Prostate Cancer

SHR-1701 in Combination With Stereotactic Body Radiotherapy in mCRPC