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Prostate CancerPhase 3NCT03777982

Conventional Androgen Deprivation Therapy (ADT) With or Without Abiraterone Acetate + Prednisone and Apalutamide Following a Detectable PSA After Radiation and ADT

A Phase 3 study testing Prednisone, Apalutamide and Abiraterone Acetate in people with Prostate Cancer, run by Dana-Farber Cancer Institute at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This research study is being offered to those patients who have received radiation therapy and who are receiving long-term hormonal therapy for their prostate cancer and whose PSA remains detectable despite having received at least 6, but no more than 12 months of hormonal therapy. 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?
Prednisone, Apalutamide and Abiraterone Acetate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
5 sitesUnited States
Study dates
20 Apr 2020to 13 Feb 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • In order to ensure a homogenous population at study entry, a bone scan and not a PET will be used to ensure M0 high risk prostate cancer. A bone scan is to be done up to 6 months prior to the start of initial ADT therapy or up to one month after initiation of ADT to rule out bony metastatic disease.
  • Histologically confirmed prostate cancer
  • PSA> undetectable (any value at or above the lower limit of detection for the assay used) after radiation and at least 6, but not more than 12 months of conventional ADT (LHRH agonist or antagonist with or without oral anti androgens, excluding abiraterone acetate and apalutamide) in patients with non-metastatic high risk or N1 prostate cancer
  • High risk is defined per the NCCN guidelines - clinical, radiographic, or pathological (biopsy proven) T3 or higher, Gleason 8-10, PSA > 20 ng/mL, the presence of intraductal, ductal, or cribriform features with any Gleason score, and can be N0 or N1
  • A month is defined as 28 days
  • Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. Subject must have the ability to understand and willingness to sign the written informed consent document.
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  • Age ≥18 at the time of consent
  • ECOG Performance Status ≤ 2 (Appendix A)
  • Demonstrate adequate organ function as defined in the table below. All screening labs to be obtained within 3 months of registration.
  • System Laboratory Value
  • Hematological:
  • Platelet count (plt)1 ≥ 100,000/ µL
  • Hemoglobin (Hgb)1 ≥ 9 g/dL
  • Absolute neutrophil count (ANC) ≥ 1000 cells/µL
  • Renal:
  • --CrCl2 ≥ 45 mL/min
  • Hepatic and Other:
  • Bilirubin3 ≤ 1.5 × upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) < 2.5 × ULN
  • Alanine aminotransferase (ALT) < 2.5 × ULN
  • Serum Albumin > 3.0 g/dL
  • Serum potassium ≥ 3.5 mmol/L
  • Coagulation:
  • --International Normalized Ratio (INR) or Prothrombin Time (PT)
  • Activated Partial Thromboplastin Time
  • (aPTT) ≤ 1.5 × ULN (unless on prophylactic or therapeutic dosing with low molecular weight heparin)
  • Independent of transfusion and/or growth factors within 3 months prior to randomization
  • Cockcroft-Gault formula will be used to calculate creatinine clearance
  • In subjects with Gilbert's syndrome, if total bilirubin is >1.5 × ULN, measure direct and indirect bilirubin; if direct bilirubin is ≤1.5 × ULN, subject may be eligible
  • Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential OR agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug.
  • Ability to understand and comply with study procedures for the entire length of the study as determined by the site investigator or protocol designee
  • Medications known to lower the seizure threshold (section 5.4.4) must be discontinued or substituted prior to C1D1 of study treatment for patients on Arm 2
  • Able to swallow pills

Who cannot join

  • Prior radical prostatectomy (excluding TURP and simple prostatectomy)
  • History of any of the following:
  • Seizure or known condition that may predispose to seizure (e.g., prior stroke within 1 year of randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign CNS or meningeal disease which may require treatment with surgery or radiation therapy)
  • Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization
  • Known current evidence of any of the following:
  • Uncontrolled hypertension. Participants with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy
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  • Gastrointestinal disorder affecting absorption
  • Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome.
  • Known active or chronic hepatitis B infection (defined as having a positive hepatitis B surface antigen (HBsAg) test at screening). Subject with past or resolved hepatitis B infection (defined as having a negative HBsAg test and positive antibody to hepatitis B core antigen test) are eligible. Hepatitis B viral DNA must be obtained in subjects with positive hepatitis B core antibody prior to first treatment start.
  • Active hepatitis C infection. Subjects positive hepatitis C antibody test are eligible if PCR is negative for hepatitis C viral DNA.
  • Pre-existing condition that warrants long-term corticosteroid use greater than the equivalent of 10 mg prednisone daily. Physiologic replacement is permitted. Topical, intra-articular steroids or inhaled corticosteroids are permitted.
  • Any condition that, in the opinion of the site investigator, would preclude participation in this study
  • Baseline moderate or severe hepatic impairment (ChildPugh Class B or C)
  • Patients who are currently receiving treatment with a prohibited medication according to Section 5.4 (Tables 2 and 3), must discontinue that medication prior to starting treatment and must not restart for the duration of the study if randomized to ARM 2.
  • Avoid co-administration of abiraterone acetate with CYP2D6 substrates that have a narrow therapeutic index. If an alternative treatment cannot be used, exercise caution and consider a dose reduction of the concomitant CYP2D6 substrate
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, psychiatric illness or social situations that would limit compliance with study requirements
  • Individuals with a history of another malignancy are not eligible if the cancer is under active treatment or the cancer can be seen on radiology scans or if they are off cancer treatment but in the opinion of their oncologist have a high risk of relapse within 5 years.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02215

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center

    Milford, Massachusetts, 01757

  • Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital

    South Weymouth, Massachusetts, 02190

Other trials in United States

About this study

Official title: A Randomized Phase III Study - Conventional Androgen Deprivation Therapy With or Without Abiraterone Acetate + Prednisone and Apalutamide Following a Detectable PSA After Radiation and Androgen Deprivation Therapy

This research study is being offered to those patients who have received radiation therapy and who are receiving long-term hormonal therapy for their prostate cancer and whose PSA remains detectable despite having received at least 6, but no more than 12 months of hormonal therapy.

The name of the study drugs involved in this study is:

  • LHRHA (luteinizing hormone-releasing hormone agonist or antagonist)
  • Abiraterone Acetate
  • Apalutamide
  • Prednisone
Read the detailed description

This research study is a Phase III clinical trial. Phase III clinical trials test the effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that an intervention is being studied. In this study, the investigational agents are apalutamide and abiraterone acetate. Abiraterone acetate (used in combination with prednisone) is an FDA (the U.S. Food and Drug Administration) approved drug for prostate cancer, but is approved in patients that have prostate cancer spread to other parts of their body and have been previously treated with ADT. Apalutamide has also been approved by the FDA for men whose cancer does not respond to hormone therapy but it is still investigational for this type of cancer.

In this research study, the investigators are looking at two methods of androgen deprivation therapy (ADT), also known as hormonal therapy, to determine which method is better for improving long term cure rates. ADT blocks the function of hormones, including testosterone which prostate cancer uses to grow and spread. The first method of ADT includes prednisone, apalutamide, and abiraterone acetate plus standard ADT and the second method of ADT is standard ADT alone for men with this type of prostate cancer. Currently, the best standard treatment for men with this type of prostate cancer includes standard ADT. All participants in this study will receive the main standard form of ADT called a luteinizing hormone-releasing hormone agonist or antagonist (LHRHA).

Conditions
Prostate Cancer
Being tested
Prednisone, Apalutamide, Abiraterone Acetate, LHRH Agonist or Antagonist
Keywords
Prostate Cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • PrednisoneDrug

    Also called Deltasone

    Taking advantage of the anti-inflammatory properties of the medication, corticosteroids are used to decrease the swelling around tumors.

  • ApalutamideDrug

    Also called ARN-509

    Apalutamide also prevents the androgens from working within the prostate cancer cells, and can ultimately lead to cancer cell death.

  • Abiraterone AcetateDrug

    Also called Zytiga

    Abiraterone acetate interferes with an enzyme that is expressed in testicular, adrenal, and prostatic tumor tissues and is required as part of the body's androgen producing process. Because of this interference the amount of androgens produced are decreased. Abiraterone acetate, blocks androgen production at three sources; the testes, the adrenal glands, as well as from the tumor itself

  • LHRH Agonist or AntagonistDrug

    Also called GnRH

    Luteinizing hormone-releasing hormone (LHRH) agonists (also called LHRH analogs or GnRH agonists) are drugs that lower the amount of testosterone made by the testicles

Study groups in NCT03777982
Study groupRoleWhat they receive
LHRH Agonist or AntagonistExperimental-LHRH agonist or antagonist should be prescribed per standard of care
Receives: Drug: LHRH Agonist or Antagonist
Prednisone+Apalutamide+Abiraterone Acetate +LHRH AgonistExperimental* LHRH agonist or antagonist should be prescribed per standard of care * Abiraterone acetate will be taken once daily * Prednisone will be taken twice daily * Apalutamide will be taken once daily
Receives: Drug: Prednisone; Drug: Apalutamide; Drug: Abiraterone Acetate; Drug: LHRH Agonist or Antagonist

What is being measured

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

  1. Metastasis Free Survival

    the composite of metastasis or any cause death

    Measured: 2 years

Secondary outcomes (5)

  1. PSA Nadir

    PSA nadir is defined as the lowest PSA after RT completion

    Measured: 2 years

  2. Castrate Resistant PSA Failure Free Survival

    Castrate resistant PSA failure is defined as the first PSA increase that is ≥ 25% and 2 ng/mL above the nadir, which is confirmed by a second value 3 or more weeks later, while the serum total testosterone level is < 50 ng/dl (per the PCWG2 criteria).

    Measured: 2 years

  3. Prostate Cancer Specific Survival

    Prostate cancer specific survival is defined the time from randomization to death from prostate cancer where death due to other causes are considered as competing risk, or censored at the last date of follow up in living patients.

    Measured: 2 years

  4. Overall Survival

    Overall survival is defined as the time from randomization to death from any cause with men censored at time of last follow up if alive.

    Measured: 2 years

  5. Disease Free Survival

    Disease free survival is measured from the date of randomization to the first recorded disease recurrence consisting of castrate resistant PSA failure and/or local, regional or distant failure and death from any cause, whichever comes first, or censored at the date of last disease assessment for those alive and disease recurrence free.

    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 posted19 Dec 2018
  2. Study start20 Apr 2020
  3. Primary completion13 Feb 2024
  4. Study completion13 Feb 2024

Why it stopped: PI is terminating the study due to slow/low accrual

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03777982
Sponsor's protocol ID
18-530
Status last verified
Sep 2024
First submitted
14 Dec 2018
Last updated
19 Sep 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor-Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Prednisone, Apalutamide and Abiraterone Acetate in people with Prostate Cancer, run by Dana-Farber Cancer Institute at 5 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 33 inclusion and 18 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: stopped early, 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 5 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 phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Metastasis Free Survival (time frame: 2 years). 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 NCT03777982.

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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