Clinical Trials /

A Study of Definitive Therapy to Treat Prostate Cancer After Prostatectomy

NCT03043807

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 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.

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 After Prostatectomy
  • Official Title: A Phase II Study of Definitive Therapy for Newly Diagnosed Men With Oligometastatic Prostate Cancer After Prostatectomy

Clinical Trial IDs

  • ORG STUDY ID: J16151
  • SECONDARY ID: IRB00120414
  • NCT ID: NCT03043807

Conditions

  • Prostate Cancer

Interventions

DrugSynonymsArms
Leuprolide AcetateLupron Deportchemohormonal and definitive therapy after prostatectomy
DocetaxelTexoterechemohormonal and definitive therapy after prostatectomy
BicalutamideCasodexchemohormonal and definitive therapy after prostatectomy
Abiraterone AcetateZytigachemohormonal and definitive therapy after prostatectomy

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 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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
chemohormonal and definitive therapy after prostatectomyExperimental(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.
  • Leuprolide Acetate
  • Docetaxel
  • Bicalutamide
  • Abiraterone Acetate

Eligibility 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.
      
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 assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4 criteria and the Clavien-Dindo Classification
Time Frame:3 years
Safety Issue:
Description: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

Measure:Two-year Undetectable PSA
Time Frame:2 years
Safety Issue:
Description:To investigate the total number and the percentage of men with an undetectable PSA at 2 years after study enrollment.
Measure:Time to PSA recurrence
Time Frame:3 years
Safety Issue:
Description:To investigate the time from an undetectable PSA (≤0.2 ng/mL) until the PSA 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: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 PET 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 PET scan).
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
Time Frame:3 years
Safety Issue:
Description:To measure quality of life through the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire, supplemented with the FACT-Taxane questionnaire
Measure:5 years overall survival
Time Frame:5 years
Safety Issue:
Description: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

Details

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

Trial Keywords

  • prostatectomy
  • androgen deprivation
  • chemotherapy
  • radiation

Last Updated

April 22, 2019