Clinical Trials /

Salvage Oligometastasectomy and Radiation Therapy in Recurrent Prostate Cancer

NCT03796767

Description:

This phase II trial studies how well surgery and radiation therapy work in treating patients with prostate cancer that has come back or spread to other parts of the body. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Surgical procedures, such as oligometastasectomy, may remove tumor cells that have spread to other parts of the body. Surgery and radiation therapy may work better in treating patients with prostate cancer that has come back or spread to other parts of the body.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Salvage Oligometastasectomy and Radiation Therapy in Recurrent Prostate Cancer
  • Official Title: Salvage Oligometastasectomy and Radiation Therapy in Recurrent Prostate Cancer (SOAR)

Clinical Trial IDs

  • ORG STUDY ID: HCI115811
  • SECONDARY ID: NCI-2018-03418
  • NCT ID: NCT03796767

Conditions

  • Recurrent Prostate Carcinoma
  • Metastatic Malignant Neoplasm in the Bone
  • Metastatic Malignant Neoplasm in the Lymph Nodes
  • Oligometastasis
  • Prostate Adenocarcinoma
  • PSA Failure

Purpose

This phase II trial studies how well surgery and radiation therapy work in treating patients with prostate cancer that has come back or spread to other parts of the body. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Surgical procedures, such as oligometastasectomy, may remove tumor cells that have spread to other parts of the body. Surgery and radiation therapy may work better in treating patients with prostate cancer that has come back or spread to other parts of the body.

Detailed Description

      PRIMARY OBJECTIVES:

      I. To assess response to treatment of oligometastatic disease.

      SECONDARY OBJECTIVES:

      I. To assess additional measurements of response to treatment of oligometastatic disease.

      II. To assess prostate-specific antigen (PSA) progression free-survival following treatment
      of oligometastatic disease.

      III. To assess disease free-survival following treatment of oligometastatic disease.

      IV. To assess time to initiation of life-long antiandrogen therapy (ADT) therapy for
      metastatic prostate cancer following treatment of oligometastatic disease.

      V. To assess the rate of undetectable PSA following treatment of oligometastatic disease in
      subjects who have previously undergone prostatectomy.

      VI. To assess the safety of the various treatment options.
    

Trial Arms

NameTypeDescriptionInterventions
Arm A (radiation therapy)ExperimentalPatients with bone metastases undergo SBR) or hypofractionated radiation per institutional standard of care guidelines at investigator's discretion.
    Arm B (salvage oligometastasectomy)ExperimentalPatients with nodal metastases undergo salvage oligometastasectomy.
      Arm C (salvage oligometastasectomy, radiation therapy)ExperimentalPatients with nodal metastases undergo salvage oligometastasectomy. Following recovery, patients undergo SBRT or hypofractionated radiation per institutional standard of care guidelines at investigator's discretion. Within 4 months following completion of salvage therapy (defined as the combination of oligometastasectomy and/or bone radiation) and depending on PSA response as well as previous treatment, patients may receive adjuvant nodal IMRT.

        Eligibility Criteria

                Inclusion Criteria:
        
                  -  Histologically proven adenocarcinoma of the prostate.
        
                  -  Recurrent prostate carcinoma after definitive therapy for primary disease defined as:
        
                       -  Post-prostatectomy (with/without adjuvant radiotherapy): Detectable or rising PSA
                          level that is > 0.2 ng/mL with a second confirmatory level of > 0.2 ng/mL after
                          1-4 weeks.
        
                       -  Post radiotherapy/ablation (without radical prostatectomy): PSA rise >= 2ng/mL
                          over nadir.
        
                  -  Subjects treated with prior definitive radiotherapy for prostate cancer who have a
                     positive 18F-fluciclovine positron emission tomography (PET) scan suggesting recurrent
                     intraprostatic disease must undergo transrectal ultrasound (TRUS) biopsy:
        
                       -  If negative, no additional treatment is required to the prostate in addition to
                          that of PET positive sites.
        
                       -  If positive, subject must undergo salvage prostatectomy or salvage radiotherapy
                          to the primary site concurrently with the study treatment.
        
                  -  Oligometastatic disease defined as 5 or fewer metastatic lesions to lymph nodes and/or
                     bones only.
        
                  -  Oligometastatic disease to pelvic or para-aortic (below inferior mesenteric artery
                     [IMA]) lymph nodes seen on standard of care molecular imaging (18F-fluciclovine PET
                     scans).
        
                  -  All subjects must be surgical candidates.
        
                  -  Eastern Cooperative Oncology Group (ECOG) performance status =< 2.
        
                  -  Platelet count >= 100,000 k/uL.
        
                  -  Hemoglobin >= 8 g/dL.
        
                  -  White blood cell (WBC) >= 2.0 k/uL.
        
                  -  Total bilirubin =< 3 x upper limit of normal (ULN).
        
                  -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 3 x ULN.
        
                  -  Alkaline phosphatase =< 3 x ULN.
        
                  -  Prothrombin time (PT)/international normalized ratio (INR) >= 1.8 if not currently
                     treated with systemic anticoagulation; PT/INR >= 3.5 if currently on anticoagulation
                     with warfarin; PT/INR cannot be assessed if the patient is currently treated with
                     novel oral anticoagulants (NOAC) such as but not limited to dabigatran, rivaroxaban
                     and apixaban.
        
                  -  Estimated creatinine clearance >= 30 mL/min as calculated from the Cockcroft-Gault
                     equation.
        
                  -  Use of condoms for male subjects who have not had surgical removal of their prostate
                     and have a partner of child bearing potential beginning at the time of informed
                     consent form (ICF) signature and lasting until at least 6 months after the last
                     radiation treatment. Because of the potential side effect on spermatogenesis
                     associated with radiation, female partners of childbearing potential must agree to use
                     a highly effective contraceptive method during and for 6 months after completing
                     treatment.
        
                  -  Recovery to baseline or =< grade 1 Common Terminology Criteria for Adverse Events
                     (CTCAE) version (v)4 from toxicities related to any prior treatments, unless adverse
                     event (AE)(s) are clinically non-significant and/or stable on supportive therapy as
                     determined by the treating physician.
        
                  -  Able to provide informed consent and willing to sign an approved consent form that
                     conforms to federal and institutional guidelines.
        
                Exclusion Criteria:
        
                  -  Known brain or visceral metastases other than regional lymph nodes as defined by
                     computed tomography (CT), magnetic resonance imaging (MRI) or 18F PET imaging.
        
                  -  Any prior systemic therapy for prostate cancer except for adjuvant treatment in the
                     context of localized disease.
        
                  -  Subjects with > 5 bone or nodal metastases.
        
                  -  Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or
                     lymphomatous/hematogenous malignancy unless continually disease free for a minimum of
                     3 years from diagnosis. All patients with in situ carcinoma are eligible for this
                     study (for example, carcinoma in situ of the oral cavity is eligible) except patients
                     with carcinoma of the bladder (including in situ bladder cancer or superficial bladder
                     cancer).
        
                  -  Use of finasteride within 30 days prior to initiation of therapy. Baseline PSA should
                     not be obtained prior to 30 days after stopping finasteride.
        
                  -  Use of dutasteride within 90 days prior to initiation of therapy. Baseline PSA should
                     not be obtained prior to 90 days after stopping dutasteride.
        
                  -  Use of any prohibited therapy.
        
                  -  Active, uncontrolled, significant intercurrent or recent illness including, but not
                     limited to, the following conditions:
        
                       -  Cardiovascular disorders:
        
                            -  Congestive heart failure New York Heart Association class 3 or 4, unstable
                               angina pectoris, serious cardiac arrhythmias.
        
                            -  Uncontrolled hypertension defined as sustained blood pressure (BP) > 150
                               mmHg systolic or > 100 mmHg diastolic despite optimal antihypertensive
                               treatment.
        
                            -  Stroke (including transient ischemic attack [TIA]), myocardial infarction
                               (MI), or other ischemic event, or thromboembolic event (e.g., deep venous
                               thrombosis, pulmonary embolism) within 6 months before first dose.
        
                       -  Acute bacterial or fungal infection requiring intravenous antibiotics at the time
                          of registration
        
                       -  Chronic obstructive pulmonary disease exacerbation or other respiratory illness
                          requiring hospitalization or precluding study therapy at the time of registration
                          or within 30 days of registration.
        
                       -  Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
              
        Maximum Eligible Age:N/A
        Minimum Eligible Age:18 Years
        Eligible Gender:Male
        Healthy Volunteers:No

        Primary Outcome Measures

        Measure:Prostate-specific antigen (PSA) response rate
        Time Frame:At 6 months after completion of treatment
        Safety Issue:
        Description:Defined according to Prostate Cancer Working Group (PCWG3) criteria as the proportion of patients achieving a PSA decline >= 90% at 6 months after completion of treatment (salvage + - adjuvant). All study data will use descriptive statistics and will be exploratory only.

        Secondary Outcome Measures

        Measure:PSA progression-free survival (PFS)
        Time Frame:Time elapsed between completion of treatment (salvage + - adjuvant) and the first occurrence of confirmed PSA progression, assessed up to 3 years
        Safety Issue:
        Description:Assessed according to PCWG3 criteria. All study data will use descriptive statistics and will be exploratory only.
        Measure:Disease-free survival
        Time Frame:Time elapsed between study enrollment and first occurrence of confirmed radiographic disease progression, assessed up to 3 years
        Safety Issue:
        Description:Assessed according to PCWG3 criteria (soft tissue by computed tomography [CT] or magnetic resonance imaging [MRI] scans according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1, bone metastasis by bone scan according to the PCWG3 criteria). All study data will use descriptive statistics and will be exploratory only.
        Measure:Time to antiandrogen therapy (ADT)
        Time Frame:Time elapsed between study enrollment and initiation of ADT, assessed up to 3 years
        Safety Issue:
        Description:All study data will use descriptive statistics and will be exploratory only.
        Measure:Rate of undetectable PSA
        Time Frame:Up to 3 years
        Safety Issue:
        Description:Defined as the proportion of patients previously treated with prostatectomy whose PSA remains =< 0.2 ng/mL after 6 and 12 months following completion of treatment (salvage + - adjuvant). All study data will use descriptive statistics and will be exploratory only.
        Measure:Incidence of adverse events
        Time Frame:Up to 3 years
        Safety Issue:
        Description:Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. All study data will use descriptive statistics and will be exploratory only.

        Details

        Phase:Phase 2
        Primary Purpose:Interventional
        Overall Status:Recruiting
        Lead Sponsor:University of Utah

        Last Updated

        January 11, 2019