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

NCT04748042 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: UMCC 2020.080HUM00187979
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Prostate Cancer; Castrate Sensitive Prostate Cancer; Oligometastatic Disease

Keywords

abiraterone; ADT; Lynparza; radiation

Outcome Measures

Primary Outcomes (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

  24 months after enrollment

Secondary Outcomes (5)

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

  Up to 36 months after enrollment

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

  Up to 36 months months after enrollment

• Time to Androgen Deprivation Therapy (ADT) restart

  Up to 36 months months after enrollment

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

  Up to 36 months after enrollment

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

  Up to 36 months after enrollment

Study Arms (1)

Abiraterone, ADT, Radiation and Olaparib

EXPERIMENTAL

Abiraterone, ADT, radiation to all metastases and Olaparib.

Drug: Abiraterone; Drug: Prednisone; Radiation: External Beam Radiotherapy; Biological: Androgen Deprivation Therapy (ADT); Drug: Olaparib

Interventions

Olaparib DRUG

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

Also known as: Lynparza, AZD2281

Abiraterone, ADT, Radiation and Olaparib

Abiraterone DRUG

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

Also known as: Zytiga

Abiraterone, ADT, Radiation and Olaparib

Prednisone DRUG

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

Abiraterone, ADT, Radiation and Olaparib

External Beam Radiotherapy RADIATION

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

Abiraterone, ADT, Radiation and Olaparib

Androgen Deprivation Therapy (ADT) BIOLOGICAL

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

Abiraterone, ADT, Radiation and Olaparib

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

abiraterone; Abiraterone Acetate; Prednisone; Androgen Antagonists; olaparib

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Zachery Reichert, MD, PhD

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 10, 2021
• Study Start: May 28, 2021
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)