A Study of Definitive Therapy to Treat Prostate Cancer After Prostatectomy

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03043807
Collaborator
(none)
26
2
1
83.3
13
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Study Details

Study Description

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
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.

Radiation (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).

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

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
N/A
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 :
Feb 22, 2017
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

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 Names:
  • 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 Names:
  • Texotere
  • Drug: Bicalutamide
    bicalutamide (Casodex) 50mg by mouth daily
    Other Names:
  • 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 Names:
  • Zytiga
  • Outcome Measures

    Primary Outcome Measures

    1. Efficacy as assessed by 3-year PSA progression-free survival rate [3 years]

      To evaluate efficacy of multimodality therapy in men, defined as the 3 year PSA progression-free (PSA<0.2 ng/ml) survival rate among men who have non-castrate testosterone levels 2 years after enrollment.

    Secondary Outcome Measures

    1. Safety of the 3 years multimodality therapy assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4 criteria and the Clavien-Dindo Classification [2 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

    2. Time to PSA recurrence [3 years]

      To investigate the time from an undetectable PSA (≤0.2 ng/mL) until the PSA is >0.2 over two time-points.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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:

    4. Hormonal therapy (e.g. leuprolide, goserelin, triptorelin, degarelix)

    5. CYP-17 inhibitors (e.g. ketoconazole)

    6. Antiandrogens (e.g. bicalutamide, nilutamide)

    7. Second generation antiandrogens (e.g. enzalutamide, abiraterone)

    8. Immunotherapy (e.g. sipuleucel-T, ipilimumab)

    9. 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.

    10. 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.

    11. Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.

    12. Abnormal bone marrow function [absolute neutrophil count (ANC)<1500/mm3, platelet count <100,000/mm3, hemoglobin <9 g/dL]

    13. Abnormal liver function (bilirubin >ULN; AST, ALT > 2.5 x upper limit of normal)

    14. Creatinine clearance of ≥ 30 mL/min. CrCl should be calculated suing the Cockcroft-Gault formula.

    15. Active cardiac disease defined as active angina, symptomatic congestive heart failure, or myocardial infarction within previous six months.

    16. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Johns Hopkins Sibley Memorial Hospital Washington District of Columbia United States 20016
    2 The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland United States 21231

    Sponsors and Collaborators

    • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Investigators

    • Principal Investigator: Kenneth Pienta, MD, SKCCC at Johns Hopkins University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    ClinicalTrials.gov Identifier:
    NCT03043807
    Other Study ID Numbers:
    • J16151
    • IRB00120414
    First Posted:
    Feb 6, 2017
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 31, 2022