Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Prostatic Neoplasms

Genital Neoplasms, Male

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Genital Diseases, Male

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Prostatic Diseases

Male Urogenital Diseases

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Antineoplastic Agents

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Antineoplastic Agents, Hormonal

Radical prostatectomy (and post-operative fractionated radiotherapy for pT=3a, pN1, or positive margins), metastasis directed SBRT, and complete ADT with LHRH analog leuprolide, abiraterone acetate with prednisone, and apalutamide (ARN-509) for a total of six months of systemic therapy.

radical prostatectomy

stereotactic body radiotherapy

apalutamide

abiraterone

Nicholas George Nickols, MD PhD

This is a trial for patients with newly diagnosed metastatic prostate cancer with 5 or fewer sites of metastases. The trial involves surgery (removal of the prostate) or radiation to the prostate, six months of hormone therapy, and stereotactic body radiotherapy to the sites of metastasis.

This is a single arm Phase II clinical trial in patients with newly diagnosed M1a,b prostate cancer and 1-5 radiographically visible metastases treated with radical prostatectomy (and post-operative fractionated radiotherapy for pT 3a, pN1, or positive margins) or radiation to the prostate, metastasis directed SBRT, and complete ADT with LHRH analog leuprolide, abiraterone acetate with prednisone, and apalutamide (ARN-509) for a total of six months of systemic therapy. The primary endpoint of our study is the percent of patients achieving a serum PSA of \<0.05 ng/mL six months after recovery of serum testosterone (for patients undergoing radical prostatectomy) or PSA \<nadir+2 (for patients undergoing prostate radiation).

Systemic and Tumor-Directed Therapy for Oligometastatic Prostate Cancer

PSA is a biomarker for disease burden in prostate adenocarcinoma and offers a non-invasive and sensitive assessment of disease control after treatment in the vast majority of patients.

antineoplastic therapy includes any systemic or focal anti-prostate cancer therapy

This uses the Functional Assessment of Cancer Therapy - Prostate (FACT-P) questionnaire. It assesses patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Items are rated on a 0 to 4 Likert type scale and combined to produce subscale scores for each domain and a global score, the higher the score, the better the quality of life. Range from 0-150 . Data will be aggregated per patient and over time.

CTCAE v4 criteria are a set of criteria for the standardized classification of adverse effects cancer therapy. The CTCAE system is a product of the US National Cancer Institute. The criteria are assessed by physician. The grades range from 0 to 5 (higher is worse). Data will be aggregated per patient and over time and classified by organ system (e.g., genitourinary, gastrointestinal, etc).

VA Office of Research and Development

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Systemic and Tumor-Directed Therapy for Oligometastatic Prostate Cancer	NCT03298087	Newly Diagnosed...	radical prostat... stereotactic bo... Leuprolide apalutamide abiraterone	18 Years -	VA Office of Research and Development
Systemic and Tumor-Directed Therapy for Oligometastatic Prostate Cancer	NCT03298087	Newly Diagnosed...	radical prostat... stereotactic bo... Leuprolide apalutamide abiraterone	18 Years -	VA Office of Research and Development

Spots Global Cancer Trial Database for newly diagnosed oligometastatic prostate cancer