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A Study of Definitive Therapy to Treat Prostate Cancer After Prostatectomy

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ClinicalTrials.gov Identifier: NCT03043807
Recruitment Status : Recruiting
First Posted : February 6, 2017
Last Update Posted : April 18, 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 adjuvant androgen deprivation and up to 6 cycles of chemotherapy, (2nd) definitive local tumor control with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 2 years 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: Docetaxel Drug: Bicalutamide Radiation: Radiation Drug: Abiraterone Acetate Phase 2

Detailed Description:

Adjuvant 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 PSA response of at least a 50% decrease from baseline, will proceed to maximum consolidative therapy.

Local consolidation (month 7 though ~11): After completion of adjuvant chemotherapy, the men will be treated with definitive local therapy with adjuvant radiation therapy (RT). After definitive local therapy, patients will be treated with consolidative stereotactic body radiation therapy (SBRT) to the metastatic sites (if present).

Systemic consolidation: Patients will continue on androgen deprivation for a total of 2 years. They will be followed clinically and monitored with serum testosterone and PSA 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 After Prostatectomy
Actual Study Start Date : February 22, 2017
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: chemohormonal and definitive therapy after prostatectomy
(1st) Systemic chemo-hormonal therapy with up to 6-months (~24 weeks) of adjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (2nd) definitive local tumor control with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 2 years 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: Docetaxel
75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles. Dose may decreased in the following intervals: 65 mg/M2, 55 mg/M2, 35 mg/M2.
Other Name: Texotere

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

Radiation: Radiation
Radiation will be delivered in 1 to 5 fractions, and the dose and fractionation schedule will depend on the size and location of the lesion and the surrounding normal tissue constraints in accordance with AAPM Task Group 101 recommendations. Typical doses include 16 - 24 Gy in 1 fraction, 48 - 50 Gy in 4 fractions, and 50 - 60 Gy in 5 fractions.

Drug: Abiraterone Acetate
Abiraterone acetate 1000 mg / day may be given at the investigator's discretion.
Other Name: Zytiga




Primary Outcome Measures :
  1. Safety of the multimodality therapy assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4 criteria and the Clavien-Dindo Classification [ Time Frame: 3 years ]
    To assess the safety of multimodality therapy in men presenting with newly diagnosed oligometastatic prostate cancer after prostatectomy. Toxicities related to neoadjuvant therapy, radiation therapy, or stereotactic body radiation therapy (SBRT) will be assessed using CTCAE version 4 criteria. Surgical toxicities will be assessed using the Clavien-Dindo Classification


Secondary Outcome Measures :
  1. 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.

  2. 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.

  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. 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.

  5. 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.

  6. 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).

  7. 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).

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

  9. Quality of life [ Time Frame: 3 years ]
    To measure quality of life through the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire, supplemented with the FACT-Taxane questionnaire

  10. 5 years overall survival [ Time Frame: 5 years ]
    Improved 5-yr overall survival (OS) as compared to 5-yr OS in men with metastatic prostate cancer included in the Surveillance, Epidemiology, and End Results (SEER) database



Information from the National Library of Medicine

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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:

  1. Willing and able to provide written informed consent.
  2. Age ≥ 18 years
  3. Eastern cooperative oncology group (ECOG) performance status ≤2
  4. Documented histologically confirmed adenocarcinoma of the prostate
  5. 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 adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. Additionally, must be willing to be treated with a full two years of androgen deprivation.
  6. 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 PET scan)

Exclusion Criteria:

  1. Prior local non-surgical therapy to treat prostate cancer (e.g. radiation therapy, brachytherapy)
  2. Prior therapy to a metastatic site.
  3. Prior or ongoing systemic therapy for prostate cancer including, but not limited to:

    1. Hormonal therapy (e.g. leuprolide, goserelin, triptorelin, degarelix)
    2. 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 2 years of androgen deprivation would begin at the time of therapy initiation, rather than at study enrollment.
  4. 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.
  5. Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.
  6. Abnormal bone marrow function [absolute neutrophil count (ANC)<1500/mm3, platelet count <100,000/mm3, hemoglobin <9 g/dL]
  7. Abnormal liver function (bilirubin >ULN; AST, ALT > 2.5 x upper limit of normal)
  8. Creatinine clearance of ≥ 30 mL/min. CrCl should be calculated suing the Cockcroft-Gault formula.
  9. Active cardiac disease defined as active angina, symptomatic congestive heart failure, or myocardial infarction within previous six months.
  10. 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): NCT03043807


Contacts
Contact: Rana Sullivan, RN 410-614-6337 Tomalra@jhmi.edu
Contact: Donna Dowling, RN 410-614-9526 Ddowlin1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins School of Medicine - Sidney Kimmel Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21205
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231
Contact: Rana Sullivan    410-614-6337    tomalra@jhmi.edu   
Contact: Donna Dowling    410-614-9526    ddowlin1@jhmi.edu   
Principal Investigator: Kenneth Pienta, MD         
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: NCT03043807     History of Changes
Other Study ID Numbers: J16151
IRB00120414 ( Other Identifier: JHU IRB )
First Posted: February 6, 2017    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
prostatectomy
androgen deprivation
chemotherapy
radiation

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Bicalutamide
Abiraterone Acetate
Leuprolide
Androgens
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Hormone Antagonists
Cytochrome P-450 Enzyme Inhibitors
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Androgen Antagonists