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Salvage Oligometastasectomy and Radiation Therapy in Recurrent Prostate Cancer (SOAR)

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ClinicalTrials.gov Identifier: NCT03796767
Recruitment Status : Recruiting
First Posted : January 8, 2019
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
University of Utah

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Recurrent Prostate Carcinoma Metastatic Malignant Neoplasm in the Bone Metastatic Malignant Neoplasm in the Lymph Nodes Oligometastasis Prostate Adenocarcinoma PSA Failure Radiation: Hypofractionated Radiation Therapy Radiation: Intensity-Modulated Radiation Therapy Procedure: Metastasectomy Other: Quality-of-Life Assessment Other: Questionnaire Administration Radiation: Stereotactic Body Radiation Therapy Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Salvage Oligometastasectomy and Radiation Therapy in Recurrent Prostate Cancer (SOAR)
Actual Study Start Date : January 10, 2019
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : December 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Arm A (radiation therapy)
Patients with bone metastases undergo SBR) or hypofractionated radiation per institutional standard of care guidelines at investigator's discretion.
Radiation: Hypofractionated Radiation Therapy
Undergo hypofractionated radiation therapy
Other Names:
  • Hypofractionated Radiotherapy
  • hypofractionation

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Radiation: Stereotactic Body Radiation Therapy
Undergo SBRT
Other Names:
  • SABR
  • SBRT
  • Stereotactic Ablative Body Radiation Therapy

Experimental: Arm B (salvage oligometastasectomy)
Patients with nodal metastases undergo salvage oligometastasectomy.
Procedure: Metastasectomy
Undergo salvage oligometastasectomy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Experimental: Arm C (salvage oligometastasectomy, radiation therapy)
Patients 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.
Radiation: Hypofractionated Radiation Therapy
Undergo hypofractionated radiation therapy
Other Names:
  • Hypofractionated Radiotherapy
  • hypofractionation

Radiation: Intensity-Modulated Radiation Therapy
Undergo IMRT
Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy

Procedure: Metastasectomy
Undergo salvage oligometastasectomy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Radiation: Stereotactic Body Radiation Therapy
Undergo SBRT
Other Names:
  • SABR
  • SBRT
  • Stereotactic Ablative Body Radiation Therapy




Primary Outcome Measures :
  1. Prostate-specific antigen (PSA) response rate [ Time Frame: At 6 months after completion of treatment ]
    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 :
  1. 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 ]
    Assessed according to PCWG3 criteria. All study data will use descriptive statistics and will be exploratory only.

  2. Disease-free survival [ Time Frame: Time elapsed between study enrollment and first occurrence of confirmed radiographic disease progression, assessed up to 3 years ]
    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.

  3. Time to antiandrogen therapy (ADT) [ Time Frame: Time elapsed between study enrollment and initiation of ADT, assessed up to 3 years ]
    All study data will use descriptive statistics and will be exploratory only.

  4. Rate of undetectable PSA [ Time Frame: Up to 3 years ]
    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.

  5. Incidence of adverse events [ Time Frame: Up to 3 years ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03796767


Contacts
Contact: Kristen Jewkes 801-587-4776 Kristen.Jewkes@hci.utah.edu

Locations
United States, Utah
Huntsman Cancer Institute/University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Brock O'Neil    801-581-2401    Brock.Oneil@hsc.utah.edu   
Principal Investigator: Brock O'Neil         
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Brock O'Neil Huntsman Cancer Institute/ University of Utah

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT03796767     History of Changes
Other Study ID Numbers: HCI115811
NCI-2018-03418 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Prostatic Neoplasms
Neoplasms
Adenocarcinoma
Neoplasms, Second Primary
Bone Neoplasms
Bone Marrow Diseases
Neoplasm Metastasis
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Neoplastic Processes
Pathologic Processes