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A Study of Definitive Therapy to Treat Prostate Cancer (oligo-mets)

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ClinicalTrials.gov Identifier: NCT02716974
Recruitment Status : Recruiting
First Posted : March 23, 2016
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:
To assess the safety of treating men with oligometastatic prostate cancer with the following therapy: (1st) Systemic chemo-hormonal therapy with up to 6-months (~24 weeks) of neoadjuvant androgen deprivation and up to 6 cycles of chemotherapy, (2nd) definitive local tumor control with prostatectomy +/- adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 1 year of androgen deprivation. Androgen blockade will be the same throughout the course of treatment.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Leuprolide Acetate Drug: Bicalutamide Drug: Docetaxel Procedure: Prostatectomy Radiation: Radiation Phase 2

Detailed Description:

Neoadjuvant treatment (month 1 through ~6): All patients will be treated with up to 6 months of androgen deprivation, plus up to 6 cycles of docetaxel chemotherapy. Following docetaxel therapy, patients with a prostate-specific antigen response of at least a 50% decrease from baseline, will proceed to maximum consolidative therapy.

Local consolidation (month 7 though ~11): After completion of neoadjuvant therapy, the men will be treated with definitive local therapy with radical prostatectomy (RP) +/- adjuvant radiation therapy (RT). After definitive local therapy, patients will be treated with consolidative stereotactic body radiation therapy (SBRT) to the metastatic sites.

Systemic consolidation: Patients will continue on androgen deprivation for a total of 1 year. They will be followed clinically and monitored with serum testosterone and prostate-specific antigen until 2-years after completion of systemic consolidation. Androgen blockade will be the same throughout the course of treatment.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Definitive Therapy for Newly Diagnosed Men With Oligometastatic Prostate Cancer
Study Start Date : June 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: chemohormonal and definitive therapy
(1st) Systemic chemo-hormonal therapy with up to 6-months (~24 weeks) of neoadjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (2nd) definitive local tumor control with prostatectomy +/- adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 1 year of androgen deprivation. Androgen blockade (Bicalutamide) will be the same throughout the course of treatment.
Drug: Leuprolide Acetate
22.5mg by intramuscular (IM) injection every 3 months
Other Name: Lupron Deport

Drug: Bicalutamide
bicalutamide (Casodex) 50mg by mouth daily
Other Name: Casodex

Drug: Docetaxel
Docetaxel (taxotere) 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles.
Other Name: Texotere

Procedure: Prostatectomy
Removal of the entire prostate gland, plus some surrounding tissue.
Other Name: Radical prostatectomy

Radiation: Radiation
5 high dose radiation treatments to the metastatic (tumor has spread to other parts of the body) sites.




Primary Outcome Measures :
  1. Safety of the multimodality therapy [ Time Frame: 3 years ]
    To assess the safety and therapeutic benefit of multimodality therapy in men presenting with newly diagnosed oligometastatic prostate cancer (<5 sites of metastases). Safety is defined as the incidence of Grades 3 and 4 neutropenia and surgical- or radiation-induced toxicities.


Secondary Outcome Measures :
  1. Two-year Undetectable prostate-specific antigen [ Time Frame: 2 years ]
    To investigate the total number and the percentage of men with an undetectable Prostate-Specific Antigen at 2 years after study enrollment.

  2. Time to prostate-specific antigen recurrence [ Time Frame: 3 years ]
    To investigate the time from an undetectable prostate-specific antigen (≤0.2 ng/mL) until the prostate-specific antigen is >0.2 over two time-points.

  3. Time to castrate resistant prostate cancer [ Time Frame: 3 years ]
    To investigate the interval between study enrollment and the date of documented clinical or serological progression with testosterone less than 50 ng/dL.

  4. Overall survival [ Time Frame: 5 years ]
    To measure the period from study enrollment until death from any cause.

  5. Quality of life-Functional Assessment of Cancer Therapy-Prostate (FACT-P) [ Time Frame: 3 years ]
    The FACT-P measures quality of life related to prostate cancer.

  6. Quality of life-Functional Assessment of Cancer Therapy-Taxane (FACT-T) [ Time Frame: 3 years ]
    The FACT-taxane measures quality of life related to chemotherapy treatment.

  7. The time interval from completion of treatment on study until the first chemotherapy. [ Time Frame: 3 years ]
    To investigate the time from end of androgen deprivation (or last treatment on study) until the time-point when chemotherapy is given off-study.

  8. The time interval from completion of treatment on study until the first androgen deprivation therapy. [ Time Frame: 3 years ]
    To investigate the time from end of androgen deprivation until the time-point when androgen deprivation is given off-study.

  9. The time interval from completion of treatment on study until any new metastases. [ Time Frame: 3 years ]
    To investigate the time from end of androgen deprivation until the time-point when a new metastasis is demonstrated on imaging (CT scan, bone scan, or positron emission tomography scan).

  10. The location of first distant metastatic progression [ Time Frame: 3 years ]
    To investigate the time from end of androgen deprivation until the time-point when a new metastasis, outside of the pelvis, is demonstrated on imaging (CT scan, bone scan, or positron emission tomography scan).

  11. 5 years overall survival [ Time Frame: 5 years ]
    Improved 5-yr overall survival as compared to 5-yr overall survival in men with metastatic prostate. cancer included in the Surveillance Epidemiology End Results Program database



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willing and able to provide written informed consent.
  • Age ≥ 18 years
  • Eastern cooperative group (ECOG) performance status ≤2
  • Documented histologically confirmed adenocarcinoma of the prostate
  • Willing to undergo the following therapy: (1st) Systemic chemo-hormonal therapy with up to 6-months (~24 weeks) of neoadjuvant androgen deprivation and up to 6 cycles of chemotherapy, (2nd) definitive local tumor control with prostatectomy +/- adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. Additionally, must be willing to be treated with a full year of androgen deprivation.
  • Oligometastatic prostate cancer: Stage T1-4, N0-1 and/or M1a-b (up to 5 metastatic lesions- including bone lesions and non-regional lymph nodes seen on bone scan, contrast enhanced CT scan, or positron emission tomography scan)
  • Able to swallow the study drugs whole as tablets

Exclusion Criteria:

  • Prior local therapy to treat prostate cancer (e.g. radical prostatectomy, radiation therapy, brachytherapy)
  • Prior therapy to a metastatic site.
  • Prior or ongoing systemic therapy for prostate cancer including, but not limited to:

    1. Hormonal therapy (e.g. leuprolide, goserelin, triptorelin, degarelix)
    2. Cytochrome (CYP) -17 inhibitors (e.g. ketoconazole)
    3. Antiandrogens (e.g. bicalutamide, nilutamide)
    4. Second generation antiandrogens (e.g. enzalutamide, abiraterone)
    5. Immunotherapy (e.g. sipuleucel-T, ipilimumab)
    6. Chemotherapy (e.g. docetaxel, cabazitaxel) *Note: may be enrolled if hormone therapy was recently initiated (<90 days duration). In the event that hormone therapy was initiated prior to study enrollment, the clock for 1 year of androgen deprivation would begin at the time of therapy initiation, rather than at study enrollment.
  • Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study.
  • Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.
  • Abnormal bone marrow function [absolute neutrophil count (ANC)<1500/mm3, platelet count <100,000/mm3, hemoglobin <9 g/dL]
  • Abnormal liver function (bilirubin >upper limit of normal; aspartate aminotransferase , alanine aminotransferase > 2.5 x upper limit of normal)
  • Creatinine clearance of ≥ 30 mL/min. Creatinine clearance should be calculated suing the Cockcroft-Gault formula.
  • Active cardiac disease defined as active angina, symptomatic congestive heart failure, or myocardial infarction within previous six months.
  • Prior history of malignancy in the past 3 years with the exception of basal cell and squamous cell carcinoma of the skin. Other malignancies that are considered to have a low potential to progress may be enrolled at discretion of PI.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02716974


Contacts
Contact: Carolyn Chapman, RN 443-287-7841 cchapma7@jhmi.edu
Contact: Tanya O'Neal, RN 410-955-9797 toneal2@jhmi.edu

Locations
United States, District of Columbia
Sibley Memorial Hospital Recruiting
Washington, District of Columbia, United States, 20016
Contact: Channing Paller, MD    202-660-6500    cpaller1@jhmi.edu   
United States, Maryland
Johns Hopkins School of Medicine - Sidney Kimmel Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21205
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Christian Pavlovich, MD    410-550-3338    cpavlov2@jhmi.edu   
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Investigators
Principal Investigator: Kenneth Pienta, MD SKCCC at Johns Hopkins University

Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT02716974     History of Changes
Other Study ID Numbers: J1618
IRB00070003 ( Other Identifier: JHU IRB )
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
Lupron
Bicalutamide
Docetaxel

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Bicalutamide
Leuprolide
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists