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 time to disease recurrence following treatment of oligometastatic disease.

      IV. To assess time to initiation of antiandrogen therapy (ADT) 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 safety. VII. To assess the impact of study treatment on change in quality of
      life over three years.
    

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 a
                          minimum of 1 week.
        
                       -  Post radiotherapy/ablation (without radical prostatectomy): PSA rise >= 2ng/mL
                          over nadir.
        
                  -  Subjects treated with prior definitive radiotherapy for prostate cancer who have
                     positive molecular imaging (e.g., fluciclovine PET/CT scan or other per PI discretion)
                     suggesting recurrent intraprostatic disease must undergo transrectal ultrasound (TRUS)
                     biopsy less than or equal to one year before study enrollment:
        
                       -  If the TRUS biopsy is negative, no additional treatment is required to the
                          prostate in addition to that of scan positive sites.
        
                       -  If the TRUS biopsy is positive, subject must undergo salvage prostatectomy or
                          salvage radiotherapy to the primary site concurrently with the study treatment
                          per the treatment protocol algorithm.
        
                  -  Oligometastatic disease defined as 10 or fewer metastatic lesions to lymph nodes
                     and/or bones only.
        
                  -  For patients with oligometastatic disease involving lymph nodes, metastasis is
                     confined to the pelvic or para-aortic (below IMA) regions on molecular imaging (e.g.,
                     fluciclovine PET/CT or PSMA PET/CT scan or other per PI discretion).
        
                  -  All subjects must be surgical candidates if surgery is indicated per the treatment
                     algorithm.
        
                  -  Eastern Cooperative Oncology Group (ECOG) performance status =< 2.
        
                  -  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)5 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 lymph nodes as defined by CT, MRI, or
                     othermolecular imaging (e.g., fluciclovine PET/CT or PSMA PET/CT scan or other per PI
                     discretion).
        
                  -  Patients actively receiving hormone therapy for prostate cancer. Patients may have
                     received hormone therapy perviously but must have documented non-castrate levels of
                     testosterone (>50 ng/dL)
        
                  -  Prior or concurrent malignancy whose natural history or treatment, in the opinion of
                     the enrolling investigator, may have the potential to interfere wih the safety or
                     efficay assessment of the investigational treatment protocol of the study.
        
                  -  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 >= 50% 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:Time to disease recurrence
        Time Frame:Time elapsed between study enrollment and first occurrence of confirmed radiographic disease progression, assessed up to 3 years
        Safety Issue:
        Description:Time from study enrollment until the date of confirmed radiographic disease progression as defined by RECIST 1.1 and PCWG3.
        Measure:Time to antiandrogen therapy (ADT)
        Time Frame:Time elapsed between study enrollment and initiation of ADT 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:Patients previously treated with prostatectomy evaluate the proportion of patients 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.
        Measure:Assess impact of study treatment on Change in quality of life over 3 years
        Time Frame:Up to 3 years
        Safety Issue:
        Description:Quality of Life (QOL) questionnaires (FACT-P and Expanded Prostate Cancer Index Composite EPIC-26) administered at screening, response assessment visit, and each follow up visit.

        Details

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

        Last Updated

        October 29, 2020