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A Multi-Center Trial of Androgen Suppression With Abiraterone Acetate, Leuprolide, PARP Inhibition and Stereotactic Body Radiotherapy in Prostate Cancer | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

A Multi-Center Trial of Androgen Suppression With Abiraterone Acetate, Leuprolide, PARP Inhibition and Stereotactic Body Radiotherapy in Prostate Cancer

A Multi-Center Trial of Androgen Suppression With Abiraterone aCetate, LEuprolide, PARP Inhibition and Stereotactic Body Radiotherapy (ASCLEPIuS): A Phase I/2 Trial in High Risk and Node Positive Prostate Cancer

NCT04194554•University of Michigan Rogel Cancer Center

View on ClinicalTrials.gov

Summary

The purpose of this study is to establish the maximum tolerable dose of niraparib when combined with prostate stereotactic body radiotherapy (SBRT), abiraterone, leuprolide, and prednisone (the phase 1 portion of the study) and determine 3-year biochemical PSA recurrence free-survival with this treatment approach (the phase 2 portion of the study).

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Pathologic biopsy proven adenocarcinoma of the prostate
•2. At least one of the following criteria:
•* cN1 on conventional or PET imaging
•* Grade group 5
•* Grade group 4
•* Grade group 3 and PSA ≥20 ng/mL
•* High probability of Radiographic T3 on MRI AND Grade group ≥2
•* Grade Group 3 AND PSA ≥10 ng/mL AND ≥50% positive biopsy cores
•3. Age ≥ 18
•4. ECOG \< 1
+6 more criteria

Exclusion Criteria

•1. Clinical or radiographic evidence of distant metastatic disease by CT/bone scan
•2. Clinical or radiographic evidence of high probability of clinical T4 disease
•3. Prostate gland size \>80 cc measured by ultrasound or MRI
•4. Prominent median lobe assessed by treating physician
•5. Lack of tissue from biopsy to be sent for correlative studies
•6. Any prior treatment for prostate cancer (incudes history of TURP within 5 years of enrollment, chemotherapy, radiation therapy, or anti-androgen therapy)
•7. Prohibited within 30 days prior to administration to study treatment: spironolactone and other investigational drug therapies.
•8. Prohibited 3 months before participant registration and during administration of study treatment: non-steroidal anti-androgens (e.g., bicalutamide, flutamide, nilutamide), steroidal antiandrogens (megestrol acetate, cyproterone acetate), oral ketoconazole, chemotherapy, immunotherapy, estrogens, radiopharmaceuticals.
•9. History of prior pelvic radiation therapy
•10. Concurrent treatment with strong CYP3A4 inducers such as phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital
+17 more criteria

Locations (6)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Cornell University

New York, New York, United States

Weill Cornell Medicine

New York, New York, United States

University Hospitals Seidman Cancer Center

Cleveland, Ohio, United States

University of Texas Southwestern

Dallas, Texas, United States

Key Dates

Start Date

November 6, 2020

Primary Completion Date

November 1, 2026

Completion Date

May 1, 2027

Last Updated

June 4, 2025

Enrollment

102

ACTUAL participants

Conditions

Prostate Cancer

Interventions

Niraparib

DRUG

Leuprolide

DRUG

Abiraterone Acetate

DRUG

Stereotactic body radiotherapy (SBRT)

RADIATION

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

NCT06842498

Metastatic Castration-Resistant Prostate Cancer

View study

RECRUITINGPHASE2

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

NCT04550494

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+29 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: June 4, 2025Data 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.

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A Multi-Center Trial of Androgen Suppression With Abiraterone Acetate, Leuprolide, PARP Inhibition and Stereotactic Body Radiotherapy in Prostate Cancer

Inclusion Criteria

Exclusion Criteria

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

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

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