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Prostate CancerPhase 1/2ASCLEPIuSNCT04194554

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

A Phase 1/2 study testing Niraparib, Leuprolide and Abiraterone Acetate in people with Prostate Cancer, run by University of Michigan Rogel Cancer Center at 6 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Niraparib, Leuprolide and Abiraterone Acetate
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
6 sitesUnited States
Study dates
6 Nov 2020to May 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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

  • Pathologic biopsy proven adenocarcinoma of the prostate
  • 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
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  • High probability of Radiographic T3 on MRI AND Grade group ≥2
  • Grade Group 3 AND PSA ≥10 ng/mL AND ≥50% positive biopsy cores
  • Age ≥ 18
  • ECOG < 1
  • Adequate organ and marrow function as defined per protocol.
  • Use of highly effective contraception (e.g. condoms) for the duration of treatment and a minimum of 120 days thereafter. Men must also agree not to donate sperm for the duration of the study participation, and for at least 120 days thereafter.
  • International Prostate Symptoms Score (IPSS) ≤ 20
  • Medically fit for treatment and agreeable to follow-up
  • Ability to understand and the willingness to sign a written informed consent
  • Tissue available for MiOncoSeq testing to assign DNA repair deficiency status

Who cannot join

  • Clinical or radiographic evidence of distant metastatic disease by CT/bone scan
  • Clinical or radiographic evidence of high probability of clinical T4 disease
  • Prostate gland size >80 cc measured by ultrasound or MRI
  • Prominent median lobe assessed by treating physician
  • Lack of tissue from biopsy to be sent for correlative studies
  • Any prior treatment for prostate cancer (incudes history of TURP within 5 years of enrollment, chemotherapy, radiation therapy, or anti-androgen therapy)
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  • Prohibited within 30 days prior to administration to study treatment: spironolactone and other investigational drug therapies.
  • 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.
  • History of prior pelvic radiation therapy
  • Concurrent treatment with strong CYP3A4 inducers such as phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital
  • Enrollment concurrently in another investigational drug study within 1 month of registration
  • History of another active malignancy within the previous 3 years except for adequately treated skin cancer or superficial bladder cancer
  • History of or active Crohn's disease or ulcerative colitis
  • Contraindication to or inability to tolerate MRIs
  • Patients with severe depression
  • Uncontrolled diabetes or known HbA1c>10
  • Any gastrointestinal disorder affecting absorption
  • Active pituitary or adrenal dysfunction
  • Patients with significant cardiovascular disease potentially including severe / unstable angina, recent history of myocardial infarction, clinically significant heart failure, cerebrovascular disease, venous thromboembolic events, clinically significant arrhythmias)
  • Uncontrolled hypertension with persistently elevated systolic blood pressure >160 mmgHg or diastolic blood pressure >100 mmHg despite anti-hypertensive agents.
  • Prolonged QTc >450 ms or any ECG changes that interfere with QT interval interpretation
  • Major surgery within 1 month of registration
  • History of myelodysplastic syndrome or leukemia
  • A known hypersensitivity to niraparib, abiraterone acetate, leuprolide, and/or prednisone
  • Active infection or other medical condition that would be a contraindication to prednisone use
  • Patients with known active hepatitis or chronic liver disease including cirrhosis
  • Any condition that in the opinion of the investigator would preclude participation in this study

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

  • University Hospitals Seidman Cancer Center

    Cleveland, Ohio, 44106

  • University of Texas Southwestern

    Dallas, Texas, 75390

  • Cornell University

    New York, New York, 10065

  • Weill Cornell Medicine

    New York, New York, 10065

  • Mayo Clinic

    Rochester, Minnesota, 55901

Other trials in United States

About this study

Official title: 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

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).

Conditions
Prostate Cancer
Being tested
Niraparib, Leuprolide, Abiraterone Acetate, Stereotactic body radiotherapy (SBRT)
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • NiraparibDrug

    given PO per dose escalation schedule

  • LeuprolideDrug

    22.5 mg q3 month

  • Abiraterone AcetateDrug

    1000 mg daily

  • Stereotactic body radiotherapy (SBRT)Radiation

    Also called Ultra-hypofractionated radiotherapy

    5-6 fraction SBRT (total dose: 37.5-40 Gy)

Study groups in NCT04194554
Study groupRoleWhat they receive
Niraparid Dose EscalationExperimentalDose Level 1: 100 mg PO daily of Niraparib but held for 5 days (+/- 2 days) prior to RT, during SBRT, and 5 days (+/- 2 days) after last fraction of SBRT Dose Level 2: 200 mg PO daily of Niraparib but held for 5 days (+/- 2 days) prior to RT, during SBRT, and 5 days (+/- 2 days) after last fraction of SBRT Dose Level 3: 200 mg PO daily of Niraparib without breaks during SBRT until completion of 6 cycles.
Receives: Drug: Niraparib; Drug: Leuprolide; Drug: Abiraterone Acetate; Radiation: Stereotactic body radiotherapy (SBRT)

What is being measured

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

  1. Dose-limiting toxicities (Phase 1)

    The proportion of patients at each dose level with dose-limiting toxicity (DLT), defined as any treatment related grade 3-5 adverse event experienced within the first 4 treatment cycles (112 days), assessed per NCI's CTCAE version 5.0.

    Measured: Up to 112 days after initial dose of niraparib

  2. Proportion of patients experiencing biochemical failure

    Change in PSA level from the beginning of study treatment for up to 3 years later will determine the biochemical failure rate. Biochemical failure will be defined using the Phoenix definition of the PSA nadir + 2 ng/mL.

    Measured: Up to 3 years after first dose of niraparib

Secondary outcomes (5)

  1. Change in health related quality of life

    Assessed via EPIC-26 questionnaire

    Measured: From baseline up to 3 years after last dose of niraparib

  2. Proportion of patients with undetectable post-treatment PSA

    Undetectable PSA will be defined as a PSA ≤0.1 ng/mL.

    Measured: Measured during the end of the 6th cycle of therapy (during week 24 +/- 7 days)

  3. Proportion of patients with distant metastases

    Distant metastases will be defined as any clinical or radiographic evidence of lymph node, bone, or visceral involvement of prostate cancer.

    Measured: Up to 5 years after first dose of niraparib

  4. Prostate cancer specific survival

    Prostate cancer specific survival will be defined as the duration of time from the start of treatment to death attributable to prostate cancer. Patients who have not died or die of non-prostate cancer related causes will be censored at the last known follow-up or date of death, respectively. Summarized using cumulative incidence or Kaplan-Meier curves as appropriate.

    Measured: Up to 5 years after first dose of niraparib

  5. Overall survival

    Overall survival (OS) will be defined as the duration of time from the start of treatment to death from any cause. Patients who have not died will be censored at the last known follow-up.Summarized using cumulative incidence or Kaplan-Meier curves as appropriate.

    Measured: Up to 5 years after first dose of niraparib

Timeline

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

  1. First posted11 Dec 2019
  2. Study start6 Nov 2020
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2029 (estimated)

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
Model description
Time to Event Continual Reassessment Method (TITE-CRM) dose-finding clinical trial design.
Masking
None (open label)
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04194554
Sponsor's protocol ID
UMCC 2019.117
Other IDs
HUM00167325
Acronym
ASCLEPIuS
Status last verified
Apr 2026
First submitted
9 Dec 2019
Last updated
1 May 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
Yes: Data that may be shared will only include individual participant data that underlie the results reported publicly in ClinicalTrials.gov or published articles, after deidentification (text, tables, figures, appendices).

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Niraparib, Leuprolide and Abiraterone Acetate in people with Prostate Cancer, run by University of Michigan Rogel Cancer Center at 6 sites 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 16 inclusion and 27 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: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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?

This study is still under way. Results are not available in the source record yet.

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?

Dose-limiting toxicities (Phase 1) (time frame: Up to 112 days after initial dose of niraparib). 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 NCT04194554.

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 1 May 2026.

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