A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery

NCT03809000

Last updated date
Study Location
American Fork Hospital
American Fork, Utah, 84003, United States
Contact
310-423-7600

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Prostate Cancer
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Pathologically (histologically) proven adenocarcinoma confirmed by prostatectomy performed within 10 years prior to registration and any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted.

- PSA level (≥ 0.7 ng/mL) within 90 days prior to registration. GnRH analog may be started no more than 42 days prior study entry, but patients must have a PSA ≥ 0.7 ng/mL prior to starting ADT.

- Hemoglobin ≥ 9.0 g/dL, independent of transfusion and/or growth factors within 90 days prior to registration.

- Platelet count ≥ 75,000 x 109/µL independent of transfusion and/or growth factors within 90 days prior to registration.

- At least 1 of the following aggressive features:

- Gleason score of 8-10 (note any Gleason score is eligible)

- Seminal vesicle invasion (SVI) (note any pT stage [AJCC v8.0] is eligible but a pT stage

≥ pT3b is considered aggressive)

- Locoregional node involvement at radical prostatectomy (pN1)

- Persistently elevated PSA post-RP nadir (PEPP) defined as PSA > 0.1 ng/mL after radical prostatectomy

- Serum albumin ≥ 3.0 g/dL within 90 days prior to registration

- GFR >35 mL/min estimated by Cockcroft-Gault or measured directly by 24 hour urine creatinine within 90 days prior to registration.

- Serum total bilirubin ≤1.5 × ULN (Note: In subjects with Gilbert's syndrome, if total bilirubin is >1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 × ULN, subject is eligible) within 90 days prior to registration.

- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <2.5 × ULN within 90 days prior to registration.

- Testosterone >50 ng/dL within 90 days prior to registration. Prior androgen deprivation (GnRH analog and/or non-steroidal antiandrogen) therapy is allowed provided that serum testosterone concentration must be ≥ 50 ng/dL prior to registration or starting ADT, whichever occurs first; 5-alpha reductase inhibitors will not impact eligibility, but must be discontinued prior to starting protocol treatment.

- History and physical with ECOG Performance Status 0-1 or within 90 days prior to registration.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Definitive clinical or radiologic evidence of metastatic disease with the exception of
locoregional lymph nodes.


- Prior invasive malignancy (except non-melanomatous skin cancer carcinoma in situ of
the male breast, penis, oral cavity, or stage Ta of the bladder, or stage I completely
resected melanoma) unless disease free for a minimum of 2 years).


- Prior systemic chemotherapy for the study cancer. Note: prior chemotherapy for a
different cancer is allowable.


- Prior radiotherapy to the region of the study cancer that would result in overlap of
radiation therapy fields.


- History of any of the following:


- Documented inflammatory bowel disease


- Transmural myocardial infarction within the last 4 months prior to registration.


- Unstable angina and/or congestive heart failure requiring hospitalization within
the last 4 months prior to registration


- Seizure disorder or condition that may predispose to seizure (e.g. prior cortical
stroke or significant brain trauma)


- Uncontrolled hypertension defined as a sustained systolic blood pressure in
excess of 150 mmHg or a sustained diastolic blood pressure in excess of 90 mmHg
despite optimized antihypertensive therapy.


- Known gastrointestinal disorder affecting absorption of oral medications.


- Active uncontrolled infection defined as an identified infectious condition that
requires active therapy that has not yet been completed.


- HIV positive patients with CD4 count < 200 cells/microliter within 30 days prior to
registration OR HIV patients under treatment with highly active antiretroviral therapy
(HAART) within 30 days prior to registration regardless of CD4 count. Note: HIV
testing is not required for eligibility for this protocol as it is self-reported. This
exclusion criterion is necessary because the treatments involved in this protocol may
be immunosuppressive and/or interact with HAART.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery
Official Title  ICMJE STEEL: A Randomized Phase II Trial of Salvage Radiotherapy With Standard vs Enhanced Androgen Deprivation Therapy (With Enzalutamide) in Patients With Post-Prostatectomy PSA Recurrences With Aggressive Disease Features
Brief Summary Patients with post-prostatectomy PSA (Prostate Specific Antigen) recurrences with aggressive disease features will receive salvage radiation therapy and standard androgen deprivation therapy (ADT) or enhanced ADT to determine if there is any improvement in progression-free survival when enhanced ADT is used compared to standard ADT.
Detailed Description

PRIMARY OBJECTIVE:

To determine whether, in men with post-prostatectomy PSA (prostate specific antigen) recurrences with aggressive disease features, salvage radiotherapy (SRT) with enhanced androgen deprivation therapy (ADT), consisting of enzalutamide (MDV3100) and a GnRH analog, will improve progression-free survival compared to SRT with standard GnRH analog -based ADT.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Radiation: Radiation Therapy
    Radiation Therapy
    Other Names:
    • RT
    • Three-Dimensional Conformal Radiation Therapy (3D-CRT)
    • Intensity-Modulated Radiation Therapy (IMRT)
    • Image-Guided Radiation Therapy (IGRT)
    • Radiotherapy
  • Drug: Enzalutamide
    Anti-androgen
    Other Name: Xtandi®
  • Drug: Bicalutamide
    Anti-androgen
    Other Name: Casodex®
  • Drug: GnRH analog
    Anti-androgen
    Other Names:
    • Gonadotropin-releasing hormone analog
    • Lupron®
    • leuprolide acetate
    • goserelin acetate
    • Eligard?
    • Viadur?
    • Zoldaex®
    • Trelstar®
Study Arms  ICMJE
  • Active Comparator: Salvage Radiation Therapy + Standard ADT
    Salvage RT will be given up to 66.60 Gy along with 24 months of a GnRH analog with or without 1-4 months of bicalutamide.
    Interventions:
    • Radiation: Radiation Therapy
    • Drug: Bicalutamide
    • Drug: GnRH analog
  • Experimental: Salvage Radiation Therapy + Enhanced ADT
    Salvage RT will be given up to 66.60 Gy along with 24 months of a GnRH analog + 24 months of enzalutamide.
    Interventions:
    • Radiation: Radiation Therapy
    • Drug: Enzalutamide
    • Drug: GnRH analog
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 16, 2019)
242
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 15, 2029
Estimated Primary Completion Date September 15, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pathologically (histologically) proven adenocarcinoma confirmed by prostatectomy performed within 10 years prior to registration and any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted.
  • PSA level (? 0.7 ng/mL) within 90 days prior to registration. GnRH analog may be started no more than 42 days prior study entry, but patients must have a PSA ? 0.7 ng/mL prior to starting ADT.
  • Hemoglobin ? 9.0 g/dL, independent of transfusion and/or growth factors within 90 days prior to registration.
  • Platelet count ? 75,000 x 109/µL independent of transfusion and/or growth factors within 90 days prior to registration.
  • At least 1 of the following aggressive features:

    • Gleason score of 8-10 (note any Gleason score is eligible)
    • Seminal vesicle invasion (SVI) (note any pT stage [AJCC v8.0] is eligible but a pT stage

      ? pT3b is considered aggressive)

    • Locoregional node involvement at radical prostatectomy (pN1)
    • Persistently elevated PSA post-RP nadir (PEPP) defined as PSA > 0.1 ng/mL after radical prostatectomy
  • Serum albumin ? 3.0 g/dL within 90 days prior to registration
  • GFR >35 mL/min estimated by Cockcroft-Gault or measured directly by 24 hour urine creatinine within 90 days prior to registration.
  • Serum total bilirubin ?1.5 × ULN (Note: In subjects with Gilbert's syndrome, if total bilirubin is >1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ?1.5 × ULN, subject is eligible) within 90 days prior to registration.
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <2.5 × ULN within 90 days prior to registration.
  • Testosterone >50 ng/dL within 90 days prior to registration. Prior androgen deprivation (GnRH analog and/or non-steroidal antiandrogen) therapy is allowed provided that serum testosterone concentration must be ? 50 ng/dL prior to registration or starting ADT, whichever occurs first; 5-alpha reductase inhibitors will not impact eligibility, but must be discontinued prior to starting protocol treatment.
  • History and physical with ECOG Performance Status 0-1 or within 90 days prior to registration.

Exclusion Criteria:

  • Definitive clinical or radiologic evidence of metastatic disease with the exception of locoregional lymph nodes.
  • Prior invasive malignancy (except non-melanomatous skin cancer carcinoma in situ of the male breast, penis, oral cavity, or stage Ta of the bladder, or stage I completely resected melanoma) unless disease free for a minimum of 2 years).
  • Prior systemic chemotherapy for the study cancer. Note: prior chemotherapy for a different cancer is allowable.
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
  • History of any of the following:

    • Documented inflammatory bowel disease
    • Transmural myocardial infarction within the last 4 months prior to registration.
    • Unstable angina and/or congestive heart failure requiring hospitalization within the last 4 months prior to registration
    • Seizure disorder or condition that may predispose to seizure (e.g. prior cortical stroke or significant brain trauma)
    • Uncontrolled hypertension defined as a sustained systolic blood pressure in excess of 150 mmHg or a sustained diastolic blood pressure in excess of 90 mmHg despite optimized antihypertensive therapy.
  • Known gastrointestinal disorder affecting absorption of oral medications.
  • Active uncontrolled infection defined as an identified infectious condition that requires active therapy that has not yet been completed.
  • HIV positive patients with CD4 count < 200 cells/microliter within 30 days prior to registration OR HIV patients under treatment with highly active antiretroviral therapy (HAART) within 30 days prior to registration regardless of CD4 count. Note: HIV testing is not required for eligibility for this protocol as it is self-reported. This exclusion criterion is necessary because the treatments involved in this protocol may be immunosuppressive and/or interact with HAART.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Edwin Posadas, MD310-423-7600[email protected]
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03809000
Other Study ID Numbers  ICMJE RTOG 3506
STEEL ( Other Identifier: RTOG Foundation )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party RTOG Foundation, Inc.
Study Sponsor  ICMJE RTOG Foundation, Inc.
Collaborators  ICMJE
  • Pfizer
  • Astellas Pharma Inc
Investigators  ICMJE
Principal Investigator:Edwin Posadas, MDRTOG Foundation
Principal Investigator:Felix Feng, MDRTOG Foundation
PRS Account RTOG Foundation, Inc.
Verification Date October 2020

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