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Prostate CancerPhase 2NCT04748042

Focal Radiation With Pulsed Systemic Therapy of Abiraterone, Androgen Deprivation Therapy (ADT), Lynparza Towards Castration Sensitive Oligometastatic Prostate Cancer (FAALCON)

A Phase 2 study testing Abiraterone, Prednisone and External Beam Radiotherapy in people with Prostate Cancer and Castrate Sensitive Prostate Cancer, run by University of Michigan Rogel Cancer Center at 1 site 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 assess the safety and effectiveness of radiation therapy with hormone therapy (ADT) and chemotherapy as an investigational study treatment for prostate cancer. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Abiraterone, Prednisone and External Beam Radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
28 May 2021to May 2027
Phase
Phase 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

  • Histologic or cytologic diagnosis of prostate adenocarcinoma (pure small cell or pure neuroendocrine prostate cancer are not allowed).
  • Prior radical prostatectomy OR external beam radiation with curative intent (e.g. HiFU or partial gland therapies are not acceptable) delivered to prostate. Patients with prior radical prostatectomy with positive margins must have undergone salvage or adjuvant radiation.
  • Have newly diagnosed oligometastatic prostate cancer based on molecular imaging (e.g. 68Ga-PSMA PET/CT or Axumin, excludes FDG-PET). Oligometastatic prostate cancer is between 1 and ≤ 5 radiation treatment sites. A site can be up to 5 cm and contain multiple lesions.
  • Newly diagnosed oligometastatic disease requires that no prior image guided radiation was given to sites outside of the prostate bed or pelvic lymph nodes that are typically treated in the salvage or adjuvant radiation setting.
  • Patients must have a PSA >0.2 ng/mL (confirmed ≥4 weeks later with subsequent rise) for those who underwent radical prostatectomy. For those with prior curative radiotherapy, they must meet the Phoenix criteria for progression (nadir of PSA + 2 ng/mL)
  • Medically fit for radiotherapy
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  • All molecular positive disease is within an anatomic distribution that (in the view of the radiation oncologist) can be treated safely per standard radiation oncology principles
  • Candidate for androgen deprivation therapy (e.g. leuprolide, goserelin, degarelix) abiraterone therapy (financial and medical) in view of medical oncology using package insert for guidance
  • Patient must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined per protocol
  • Androgen deprivation therapy with or without second generation androgen receptor inhibitors or abiraterone (when given to optimize focal therapies like surgery or radiation) in the curative setting are allowed as long as testosterone has recovered to above 150 ng/dL.
  • Androgen deprivation therapy (with or without second generation androgen receptor inhibitors or abiraterone) for metastatic disease is allowed up to 4 weeks prior to registration. If previous ADT was used in curative setting, testosterone recovery must be documented (testosterone >150 ng/dL) OR >1 year elapsed from last administration of curative attempt ADT before recent ADT was resumed.
  • ECOG ≤1
  • Patients must use a condom during treatment and for 6 months after the last dose of olaparib or abiraterone when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of childbearing potential of patients on study should also use a highly effective form of contraception.
  • Capable of giving signed informed consent

Who cannot join

  • Prior orchiectomy
  • Prior exposure to PARP inhibitors, docetaxel or cabazitaxel.
  • Has a known additional malignancy within the past 3 years that has required treatment excluding superficial squamous skin cancer or carcinoma in situ of bladder or head and neck (those are permissible).
  • Life expectancy ≤3 years in view of treating provider
  • Presence of known parenchymal brain metastasis (imaging not required in absence of symptoms)
  • Symptoms of cord compression requiring immediate radiation.
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  • Patients with myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML) or with features suggestive of MDS/AML per primary provider
  • Severe hepatic impairment (Child-Pugh Class C)
  • Patients with known active hepatitis infection (e.g. hepatitis B, or C)
  • Concurrent use of strong CYP3A inducers (e.g. phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, nevirapine, St. John's Wort) or moderate inducers (e.g bosentan, efavirenz or modafinil). The required washout period prior to starting olaparib is 5 weeks for phenobarbital or enzlautamide and 3 weeks for other agents. The washout requirement is measured from anticipated start of Olaparib, NOT from start of study.
  • Concomitant use of known strong CYP3A inhibitors (e.g. intraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boveprevir, telaprevir) or moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks. The washout requirement is measured from anticipated start of olaparib, NOT from start of study.
  • Major surgery within 2 weeks of starting study treatment and patient must have recovered from any effects of any major surgery
  • Clinically significant cardiovascular disease as evidenced by:
  • myocardial infarction or arterial thrombotic events (e.g. stroke) in the past 6 months
  • resting EKG indicating uncontrolled, potentially reversible cardiac candiation, as judged by the investigator (e.g. unstable ischemia, uncontrolled symptomatic arrhythmia, QTc Fridericia prolongation >500 ms) or patients with congenital long QT syndrome
  • severe or unstable angina, uncontrolled atrial fibrillation (controlled atrial fibrillation is allowed) or other (non-atrial fibrillation) cardiac arrhythmia requiring therapy
  • Active New York Heart Association Class II-IV heart failure
  • if any prior history of CHF (regardless of New York Heart Association assignment), a cardiac ejection fraction measurement (by echocardiography or multigated acquisition scan) is required within 6 months and mush not be <50%.
  • Planned or scheduled cardiac surgery or percutaneous coronary intervention procedure
  • Prior revascularization procedure (coronary, carotid or peripheral artery stenosis) within the past 12 months
  • History of uncontrolled pituitary or adrenal dysfunction
  • Active infection or other medical condition that would make prednisone use contraindicated
  • Any chronic medical condition requiring a systemic dose of corticosteroid >10 mg prednisone daily
  • Prior allogeneic bone marrow transplant or double umbilical cord blood transplantation
  • Participation in another clinical study with an investigational product or investigational medical devices within 1 month of registration
  • Involvement in the planning and/or conduct of the study (applies to both AstraZeneca and Merck staff and/or staff at the University of Michigan).
  • Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
  • Uncontrolled hypertension (systolic blood pressure ≥160 mmHg) of diastolic blood pressure ≥95 mmHg. Patients with documented white coat syndrome (with home blood pressure machine compared to office for calibration) are allowed if home blood pressure measured daily for a week meet eligibility
  • Known hypersensitivity to olaparib, abiraterone, planned ADT agent (e.g. leuprolide, goserelin, degarelix), any of the excipients of any of these agents (olaparib, abiraterone, planned ADT agent) or drugs with a similar chemical structure to them or class to agents (olaparib, abiraterone or planned ADT)
  • Immunocompromised patients
  • Patients who are considered a poor medical risk due to a serious uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples not discussed elsewhere include, but are not limited to uncontrolled seizure disorder, superior vena cava syndrome or any psychiatric disorder that prohibits informed consent
  • Persistent toxicities (CTCAE Grade ≥2) caused by previous cancer therapy, excluding alopecia or sensory peripheral neuropathy
  • Patients who are unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: Focal Radiation With Pulsed Systemic Therapy of Abiraterone, ADT, Lynparza Towards Castration Sensitive Oligometastatic Prostate Cancer (FAALCON): A Phase II, Single Arm, Single Institution Study

The purpose of this study is to assess the safety and effectiveness of radiation therapy with hormone therapy (ADT) and chemotherapy as an investigational study treatment for prostate cancer. This is a phase 2 study to deliver focal radiation with pulsed systemic therapy of Abiraterone, ADT and Lynparza (olaparib) in men with castration sensitive oligometastatic prostate cancer.

Being tested
Abiraterone, Prednisone, External Beam Radiotherapy, Androgen Deprivation Therapy (ADT), Olaparib
Keywords
abiraterone, ADT, Lynparza, radiation
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • AbirateroneDrug

    Also called Zytiga

    Abiraterone 1000 mg by mouth per day for approximately 6 months.

  • PrednisoneDrug

    Prednisone 5 mg by mouth per day for approximately 6 months.

  • External Beam RadiotherapyRadiation

    External beam radiotherapy, dose will depend on lesion location. Completed within 40 days of study start.

  • Androgen Deprivation Therapy (ADT)Biological

    ADT by luteinizing hormone-releasing hormone (LHRH) agonist or antagonist for 6 months.

  • OlaparibDrug

    Also called Lynparza, AZD2281

    Olaparib tablets 300 mg by mouth twice a day for approximately 5 months.

Study groups in NCT04748042
Study groupRoleWhat they receive
Abiraterone, ADT, Radiation and OlaparibExperimentalAbiraterone, ADT, radiation to all metastases and Olaparib.
Receives: Drug: Abiraterone; Drug: Prednisone; Radiation: External Beam Radiotherapy; Biological: Androgen Deprivation Therapy (ADT); Drug: Olaparib

What is being measured

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

  1. Percentage of patients without treatment failure at 24 months

    Treatment failure is defined as one of the following:

    • New or progressive metastases on Computed Tomogrophy (CT)/Magnetic Resonance Imaging (MRI) per Response Evaluation Criteria In Solid Tumors (RECIST)
    • New lesion(s) on bone scan without alternate explanations (e.g. trauma, arthritis) in distribution consistent with prostate cancer metastases, by provider assessment
    • Clinical progression by provider assessment
    • Prostate Specific Antigen (PSA) doubling time under 6 months with an absolute final PSA over 1.5 ng/mL

    Measured: 24 months after enrollment

Secondary outcomes (5)

  1. Percentage of patients with undetectable PSA, testosterone >150 ng/dL and without treatment failure.

    The number of patients who achieve an undetectable PSA (PSA ≤ 0.2 ng/mL) AND have a testosterone >150 ng/dL will be divided by the number of patients treated in the study with a 95% confidence interval (CI). This will be analyzed at 12, 18, 24 and 36 months.

    Measured: Up to 36 months after enrollment

  2. Rate of obtaining an optimal PSA (PSA ≤ 0.2 ng/mL)

    The number of patients who achieve an undetectable PSA (PSA ≤ 0.2 ng/mL) will be divided by the number of patients treated in the study with a 95% CI. This will be analyzed at 12, 18, 24 and 36 months.

    Measured: Up to 36 months months after enrollment

  3. Time to Androgen Deprivation Therapy (ADT) restart

    Time to ADT restart is defined as time from day 0 to restarting of gonadotropin-releasing hormone (GNRH) agonist or antagonist. The time to ADT restart may be determined by Kaplan-Meier methods.

    Measured: Up to 36 months months after enrollment

  4. Time to subsequent therapy (e.g. ADT, radiation)

    Time to subsequent therapy (e.g. ADT or radiation) will be measured from day 0 to start of therapy and determined by Kaplan-Meier methods.

    Measured: Up to 36 months after enrollment

  5. Frequency of adverse events grade 3 or higher and attributable to study treatment

    Adverse events >= grade 3 and attributable to study treatment (possibly, probably, likely) will be reported by body system, severity and grade, and summarized by different levels of treatment exposure, per Common Terminology Criteria for Adverse Events (CTCAE) v.5.

    Measured: Up to 36 months after enrollment

Timeline

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

  1. First posted10 Feb 2021
  2. Study start28 May 2021
  3. Primary completion2 May 2026
  4. Study completionMay 2027 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04748042
Sponsor's protocol ID
UMCC 2020.080
Other IDs
HUM00187979
Status last verified
Jul 2026
First submitted
5 Feb 2021
Last updated
13 Jul 2026
Results posted
No
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 Abiraterone, Prednisone and External Beam Radiotherapy in people with Prostate Cancer and Castrate Sensitive Prostate Cancer, run by University of Michigan Rogel Cancer Center at 1 site 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 14 inclusion and 33 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 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

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?

Percentage of patients without treatment failure at 24 months (time frame: 24 months after enrollment). 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 NCT04748042.

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 13 Jul 2026.

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