Clinical Trials /

A Study of Definitive Therapy to Treat Prostate Cancer

NCT02716974

Description:

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.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of Definitive Therapy to Treat Prostate Cancer
  • Official Title: A Phase II Study of Definitive Therapy for Newly Diagnosed Men With Oligometastatic Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: J1618
  • SECONDARY ID: IRB00070003
  • NCT ID: NCT02716974

Conditions

  • Prostate Cancer

Interventions

DrugSynonymsArms
Leuprolide AcetateLupron Deportchemohormonal and definitive therapy
BicalutamideCasodexchemohormonal and definitive therapy
DocetaxelTexoterechemohormonal and definitive therapy

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
chemohormonal and definitive therapyExperimental(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.
  • Leuprolide Acetate
  • Bicalutamide
  • Docetaxel

Eligibility 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.
      
Maximum Eligible Age:80 Years
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety of the multimodality therapy
Time Frame:3 years
Safety Issue:
Description: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

Measure:Two-year Undetectable prostate-specific antigen
Time Frame:2 years
Safety Issue:
Description:To investigate the total number and the percentage of men with an undetectable Prostate-Specific Antigen at 2 years after study enrollment.
Measure:Time to prostate-specific antigen recurrence
Time Frame:3 years
Safety Issue:
Description: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.
Measure:Time to castrate resistant prostate cancer
Time Frame:3 years
Safety Issue:
Description:To investigate the interval between study enrollment and the date of documented clinical or serological progression with testosterone less than 50 ng/dL.
Measure:Overall survival
Time Frame:5 years
Safety Issue:
Description:To measure the period from study enrollment until death from any cause.
Measure:Quality of life-Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Time Frame:3 years
Safety Issue:
Description:The FACT-P measures quality of life related to prostate cancer.
Measure:Quality of life-Functional Assessment of Cancer Therapy-Taxane (FACT-T)
Time Frame:3 years
Safety Issue:
Description:The FACT-taxane measures quality of life related to chemotherapy treatment.
Measure:The time interval from completion of treatment on study until the first chemotherapy.
Time Frame:3 years
Safety Issue:
Description:To investigate the time from end of androgen deprivation (or last treatment on study) until the time-point when chemotherapy is given off-study.
Measure:The time interval from completion of treatment on study until the first androgen deprivation therapy.
Time Frame:3 years
Safety Issue:
Description:To investigate the time from end of androgen deprivation until the time-point when androgen deprivation is given off-study.
Measure:The time interval from completion of treatment on study until any new metastases.
Time Frame:3 years
Safety Issue:
Description: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).
Measure:The location of first distant metastatic progression
Time Frame:3 years
Safety Issue:
Description: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).
Measure:5 years overall survival
Time Frame:5 years
Safety Issue:
Description: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

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Trial Keywords

  • Lupron
  • Bicalutamide
  • Docetaxel

Last Updated

June 3, 2019