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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02716974
Recruitment Status : Active, not recruiting
First Posted : March 23, 2016
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Tracking Information
First Submitted Date  ICMJE March 17, 2016
First Posted Date  ICMJE March 23, 2016
Last Update Posted Date April 8, 2021
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2020)
Efficacy as assessed by 2-year PSA progression-free survival rate [ Time Frame: 2 years ]
To evaluate efficacy of multimodality therapy in men, defined as the 2 year PSA progression-free (PSA<0.2 ng/ml) survival rate among men who have non-castrate testosterone levels 2 years after enrollment.
Original Primary Outcome Measures  ICMJE
 (submitted: March 17, 2016)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2020)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2016)
  • Two-year Undetectable PSA [ Time Frame: 2 years ]
    To investigate the total number and the percentage of men with an undetectable PSA at 2 years after study enrollment.
  • Time to PSA recurrence [ Time Frame: 3 years ]
    To investigate the time from an undetectable PSA (≤0.2 ng/mL) until the PSA is >0.2 over two time-points.
  • 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.
  • Overall survival [ Time Frame: 5 years ]
    To measure the period from study enrollment until death from any cause.
  • Quality of life [ Time Frame: 3 years ]
    To measure quality of life through the Functional Assessment of Cancer Therapy-Prostate (FACT-P) [REF] supplemented with the FACT-Taxane [REF]
  • 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.
  • 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.
  • 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 PET scan).
  • 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 PET scan).
  • 5 years overall survival [ Time Frame: 5 years ]
    Improved 5-yr OS as compared to 5-yr OS in men with metastatic prostate. cancer included in the SEER database
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Definitive Therapy to Treat Prostate Cancer
Official Title  ICMJE A Phase II Study of Definitive Therapy for Newly Diagnosed Men With Oligometastatic Prostate Cancer
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.
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.

Surgery and Radiation (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.

Follow up: 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 ADT (Androgen deprivation therapy) treatment. Androgen blockade will be the same throughout the course of treatment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • 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.
Study Arms  ICMJE 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.
Interventions:
  • Drug: Leuprolide Acetate
  • Drug: Bicalutamide
  • Drug: Docetaxel
  • Procedure: Prostatectomy
  • Radiation: Radiation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 9, 2019)
26
Original Estimated Enrollment  ICMJE
 (submitted: March 17, 2016)
33
Estimated Study Completion Date  ICMJE April 2024
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02716974
Other Study ID Numbers  ICMJE J1618
IRB00070003 ( Other Identifier: JHM IRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Sponsor  ICMJE Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kenneth Pienta, MD SKCCC at Johns Hopkins University
PRS Account Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP