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Prostatic Neoplasms

Hypersensitivity

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Urogenital Neoplasms

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Genital Diseases, Male

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Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Anti-Inflammatory Agents

Antineoplastic Agents

Androgens

Prednisone

Goserelin

Androgen Antagonists

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Goserelin will be administered SC at 10.8 mg every 12 weeks

goserelin

Enzalutamide will be given orally at 160mg once daily

Enzalutamide

Abiraterone will be taken orally at 1000 mg once daily

Abiraterone

18F-labeled agent that is a high affinity small molecule inhibitor of PSMA to detect prostate cancer via PET imaging

18F-DCFPyL

Prednisone will be taken orally at 5mg twice a day for each dose, or 10 mg once a day. Doses should be taken about 12 or 24 hours apart

Radical Prostatectomy

Fatima H Karzai, M.D.

Background:

Prostate cancer is a common cancer among men. There are several ways to treat it, including hormone blocking drugs, radiation therapy, and surgery. Researchers want to combine abiraterone and enzalutamide to see if there is a better way to treat prostate cancer. They also want to study a new radiotracer called 18F-DCFPyL, with the help of a scan called positron emission tomography/computed tomography (PET/CT) to see if there is a better way to detect prostate cancer.

Objective:

To develop improved techniques to localize and detect prostate cancer; and to develop new ways to treat prostate cancer

Eligibility:

Men ages 18 and older with prostate cancer that has not spread to other parts of the body

Design:

* Participants will have a medical evaluation to determine eligibility for the study.
* Participants will take three different medications daily by mouth and receive two injections during the course of the study.
* Participants will have a medical evaluation monthly (for 6 months) while taking the medications.
* Participants will have prostate MRI and PET/CT scans before treatment, 2 months after starting treatment and again before surgery. The radiotracer will be given by injection about 2 hours before the whole-body scan. The PET/CT scan itself is about an hour.
* Participants may be asked to do a biopsy before treatment and 2 months after starting treatment.
* Participants will have a full medical evaluation before surgery to remove their prostate.
* Participants will have a follow-up visit 3 months after surgery and then as needed.
* Participants will be contacted once a year for their PSA and testosterone levels for 5 years...

Background:

* Most men diagnosed with prostate cancer will present with intermediate or high-risk disease, and many develop castrate resistant prostate cancer (CRPC) as curative strategies are often unsuccessful
* Treatment options typically involve radical prostatectomy (RP) or radiation therapy (RT) in combination with androgen deprivation therapy (ADT)
* PET imaging based on prostate specific membrane antigen (PSMA), including use of the radiotracer DCFPyL, which binds PSMA, has emerged as a sensitive modality to detect localized and metastatic prostate cancer
* It is unknown how androgen-targeted therapy affects expression of the androgen- regulated PSMA gene, FOLH1, and 18F -DCFPyL-PET/CT sensitivity; and, the correlation between response on 18F -DCFPyL-PET/CT imaging and clinical response needs further evaluation
* The use of highly effective androgen pathway inhibitors enzalutamide and abiraterone offers an opportunity to understand the characteristics of 18F -DCFPyL-PET imaging during treatment while potentially improving the cure rate of men with potentially lethal localized prostate cancer
* There remains a great need for improved techniques to determine mechanisms of treatment response and resistance

Objectives:

- To test the feasibility of 18F -DCFPyL-PET/CT for the localization of prostate cancer before, during, and after pre-operative treatment with ADT, enzalutamide, and abiraterone/prednisone in patients negative for metastatic disease

Eligibility:

* Pathologic diagnosis of castration-sensitive prostate cancer with intermediate- or high- risk features and no evidence of metastases beyond N1 on conventional imaging
* Candidates for radical prostatectomy
* Testosterone levels greater than or equal to 100 ng/dL
* ECOG PS 0-1
* Men age greater than or equal to 18 years

Design:

* Patients will be treated with ADT, enzalutamide, and abiraterone/prednisone for 6 months, followed by standard of care radical prostatectomy (RP)
* 18F-DCFPyL-PET/CT and mpMRI scans prior to treatment, during months 3-5 and after 6 months of treatment
* Prostate tumor biopsy (MR/US-guided) samples for research analyses at baseline and after mid-treatment imaging (post-month 2)
* It is anticipated that approximately 1.5 to 2 years may be required for accrual of up to 25 evaluable subjects.

Neoadjuvant Androgen Deprivation Therapy Combined With Enzalutamide and Abiraterone Using Multiparametric MRI and 18FDCFPyL PET/CT in Newly Diagnosed Prostate Cancer

A Phase II Study of Neoadjuvant Androgen Deprivation Therapy Combined With Enzalutamide and Abiraterone Using Multiparametric MRI and 18F-DCFPyL-PET/CT in Newly Diagnosed Prostate Cancer

.All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.

The primary endpoint will be the disease status after completion of treatment relative to PSMA-PET imaging findings at 2 months

Evaluate the pathological complete response rate after neoadjuvant treatment with ADT, enzalutamide, and abiraterone/prednisone

National Cancer Institute (NCI)

Olaparib

Prolactin Release-Inhibiting Factors

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Abiraterone, ADT, radiation to all metastases and Olaparib.

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

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

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

External Beam Radiotherapy

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

Androgen Deprivation Therapy (ADT)

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

Cancer AnswerLine

Zachary Reichert, MD, PhD

Zachery Reichert, MD, PhD

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.

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

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

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

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.

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.

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.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Neoadjuvant Androgen Deprivation Therapy Combined With Enzalutamide and Abiraterone Using Multiparametric MRI and 18FDCFPyL PET/CT in Newly Diagnosed Prostate Cancer	NCT03860987	Castrate Sensit...	goserelin Enzalutamide Abiraterone 18F-DCFPyL Prednisone Radical Prostat...	18 Years -	National Institutes of Health Clinical Center (CC)
Focal Radiation With Pulsed Systemic Therapy of Abiraterone, Androgen Deprivation Therapy (ADT), Lynparza Towards Castration Sensitive Oligometastatic Prostate Cancer (FAALCON)	NCT04748042	Prostate Cancer Castrate Sensit... Oligometastatic...	Abiraterone Prednisone External Beam R... Androgen Depriv... Olaparib	18 Years -	University of Michigan Rogel Cancer Center

Spots Global Cancer Trial Database for castrate sensitive prostate cancer