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Prostate CancerPhase 2NCT03141671

Randomized Phase II Study of Salvage XRT + ADT +/- Abiraterone and Apalutamide for Rising PSA After RP (FORMULA-509)

A Phase 2 study testing GnRH, Bicalutamide and Salvage radiation in people with Prostate Cancer, run by Dana-Farber Cancer Institute at 8 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This research study is comparing two different combinations of androgen deprivation therapy (ADT) used together with radiation as a treatment for rising PSA after radical prostatectomy (prostate cancer). Read more about this study

Who is it for?
Ages 18 to 95 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
GnRH, Bicalutamide and Salvage radiation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
345 participants
Where
8 sitesUnited States
Study dates
24 Nov 2017to 31 Dec 2025
Phase
Phase 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 to 95 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed prostate cancer
  • PSA ≥ 0.1 after radical prostatectomy (value w/in 3 months of registration) AND at least 1 unfavorable risk factor listed below.
  • Gleason 8-10
  • PSA > 0.5
  • Pathologically positive lymph nodes
  • pT3 or pT4
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  • PSA doubling time (DT) < 10 months
  • Negative margins
  • Persistent PSA after RP (PSA never dropped below 0.1 after RP)
  • Local/regional recurrence on imaging
  • Decipher "High risk" (a Medicare-reimbursed test for risk of metastases after prostatectomy)
  • Candidate for salvage radiation and ADT treatment
  • 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.
  • 18 ≤ Age ≤ 95 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) ≥ 100,000/ µL
  • Hemoglobin (Hgb) ≥ 9 g/dL
  • Absolute neutrophil count (ANC) ≥ 1000 cells/µL
  • Renal:
  • --GFR1 ≥ 45 mL/min
  • Hepatic and Other:
  • Bilirubin2 ≤ 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)
  • Cockcroft-Gault formula will be used to calculate creatinine clearance (see study procedure manual SPM)
  • 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 (see list under prohibited meds) must be discontinued or substituted at least 4 weeks prior to study entry (Section 5.5)
  • Use of CYP3A4 inhibitors or inducers and CYP2D6 substrates must be discontinued prior to study entry
  • Able to swallow pills

Who cannot join

  • Use of post-prostatectomy ADT for > 30 continuous days prior to registration (ADT defined as use of GnRH agonist, with or without an anti-androgen). However, patients with testosterone recovery after post-prostatectomy ADT are eligible (testosterone recovery defined as total testosterone > 190 ng/dL) regardless of how long they have been on ADT.
  • Prior pelvic radiation unless additional radiation can be safely delivered according to the treating physician
  • PSA > 15 ng/mL in screening
  • 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 (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization
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  • Current evidence of any of the following:
  • Uncontrolled hypertension
  • Gastrointestinal disorder affecting absorption
  • Active infection (e.g., human immunodeficiency virus [HIV] or viral hepatitis)
  • Any chronic medical condition requiring a dose of corticosteroid higher than 10 mg prednisone/prednisolone once daily
  • Any condition that, in the opinion of the site investigator, would preclude participation in this study
  • Moderate or severe hepatic impairment (Child Pugh Class B or C)
  • 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
  • Confirmed bone metastases on imaging

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Dana-Farber Cancer Institute/Brigham and Women's Hospital

    Boston, Massachusetts, 02215

  • University of Chicago

    Chicago, Illinois, 60637

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Yale Cancer Center

    New Haven, Connecticut, 06510

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • University of California, San Diego

    San Diego, California, 92093

  • University of California, San Francisco

    San Francisco, California, 94158

Other trials in United States

About this study

Official title: Randomized Phase II Study of Salvage XRT + ADT +/- Abiraterone Acetate and Apalutamide (ARN-509) for Rising PSA After Radical Prostatectomy With Adverse Features.(FORMULA-509 Trial)

This research study is comparing two different combinations of androgen deprivation therapy (ADT) used together with radiation as a treatment for rising PSA after radical prostatectomy (prostate cancer).

Read the detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and 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.

Currently, the best standard treatment for men with this type of prostate cancer includes radiation therapy combined with androgen deprivation therapy (ADT). ADT blocks the function of hormones including testosterone which prostate cancer uses to grow and spread. All participants in this study will receive the main standard form of ADT called a luteinizing hormone-releasing hormone agonist (LHRHA). Physicians often also use another drug called bicalutamide to help the LHRHA block hormone function. The investigators are testing whether using two newer anti-hormonal drugs called abiraterone acetate and apalutamide with LHRHA can improve cure rates compared to using bicalutamide plus LHRHA. These two drugs work together to suppress both testosterone and the receptor where testosterone binds thereby providing more potent hormone suppression.

Conditions
Prostate Cancer
Being tested
GnRH, Bicalutamide, Salvage radiation, Abiraterone, Prednisone
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.

  • GnRHDrug

    Also called LHRHA

    -blocks the function of hormones including testosterone which prostate cancer uses to grow and spread

  • BicalutamideDrug

    Also called Casodex

    -blocks the function of hormones including testosterone which prostate cancer uses to grow and spread

  • Salvage radiationRadiation

    Radiation

  • AbirateroneDrug

    Also called Zytiga

    -blocks the function of hormones including testosterone which prostate cancer uses to grow and spread

  • PrednisoneDrug

    Also called Deltasone

    Prednisone is a corticosteroid. It prevents the release of substances in the body that cause inflammation. It also suppresses the immune system.

  • ApalutamideDrug

    Also called ARN-509

    -blocks the function of hormones including testosterone which prostate cancer uses to grow and spread

Study groups in NCT03141671
Study groupRoleWhat they receive
GnRH + BicalutamideExperimental* GnRH agonist injection monthly or every 3 months for 6 months * Bicalutamide by mouth once/day for 6 months * Salvage radiation (starting 4-10 weeks after initiation of ADT)
Receives: Drug: GnRH; Drug: Bicalutamide; Radiation: Salvage radiation
GnRH+Abiraterone+Apalutamide+PrednisoneExperimental* GnRH agonist injection monthly or every 3 months for 6 months * Abiraterone acetate by mouth once/day for 6 months * Prednisone by mouth once/day for 6 months * Apalutamide by mouth once/day for 6 months * Salvage radiation (starting 4-10 weeks after initiation of ADT)
Receives: Drug: GnRH; Radiation: Salvage radiation; Drug: Abiraterone; Drug: Prednisone; Drug: Apalutamide

What is being measured

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

  1. PSA Progression Free Survival

    Time from randomization to PSA failure or death due to any cause

    Measured: Up to 5 years

Secondary outcomes (11)

  1. Metastasis Free Survival on conventional imaging or pathologically (MFS)

    Time from randomization to distant metastasis, identified on conventional imaging (CT, bone scan, or MRI) or pathologically, or death due to any cause or censored at date last known alive.

    Measured: Up to 5 years

  2. Metastasis Free Survival only visible by PET Imaging (MFS-PET)

    Time from randomization to distant metastasis, visible only by PET portion of a PET-CT, or death due to any cause or censored at date last known alive.

    Measured: Up to 5 years

  3. Cause Specific Survival

    The interval from randomization to the date of last known follow-up alive or date of death from each of the following causes: prostate cancer, cardiovascular disease, other causes.

    Measured: Up to 5 years

  4. Overall Survival

    Time from randomization to death due to any cause or censored at date last known alive

    Measured: Up to 5 years

  5. Time to Testosterone Recovery

    Time from randomization to date at which testosterone level returns to a normal level, or censored at the date of last disease evaluation for those whose testosterone has not reached a normal level

    Measured: Up to 5 years

  6. Toxicity as measured by CTCAE v.4.0

    Measure Grade 1-5 toxicities at study visits and follow-up using the CTCAE v.4.0 forms and determine attribution

    Measured: Up to 5 years

  7. Time to reinitiation of ADT

    Time from randomization to date at which ADT is restarted for disease progression. Censoring occurs at date of last disease evaluation for those who are not restarted on ADT.

    Measured: Up to 5 years

  8. Patient reported QOL

    Patient-reported Quality of Life will be measured by a fatigue questionnaire

    Measured: Up to 5 years

  9. Patient reported QOL

    Patient-reported Quality of Life will be measured by a questionnaire assessing symptoms related to prostate cancer

    Measured: Up to 5 years

  10. Patient reported QOL

    Patient-reported Quality of Life will be measured by a memory survey

    Measured: Up to 5 years

  11. Cardiovascular events consisting of myocardial infarction

    Time from randomization to date at which first cardiovascular event (myocardial infarction, stroke, deep venous thrombosis, or pulmonary embolism) occurs. Censoring occurs at date of last disease evaluation for those who did not have a cardiovascular event.

    Measured: Up to 5 years

Timeline

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

  1. First posted5 May 2017
  2. Study start24 Nov 2017
  3. Primary completion5 Apr 2025 (estimated)
  4. Study completion31 Dec 2025 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
345 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03141671
Sponsor's protocol ID
16-623
Status last verified
May 2024
First submitted
3 May 2017
Last updated
14 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GnRH, Bicalutamide and Salvage radiation in people with Prostate Cancer, run by Dana-Farber Cancer Institute at 8 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 42 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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 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?

Results are not available in the source record.

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?

PSA Progression Free Survival (time frame: Up to 5 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 NCT03141671.

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 14 May 2024.

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