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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Adenocarcinoma; Metastatic Malignant Neoplasm in the Bone; Metastatic Malignant Neoplasm in the Lymph Nodes; Recurrent Prostate Carcinoma; Oligometastasis; PSA Failure
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Intensity-Modulated Radiation Therapy; Radiation: Stereotactic Body Radiation Therapy; Radiation: Hypofractionated Radiation Therapy; Procedure: Metastasectomy

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Kristen Jewkes; Phone Number: 801-587-4776; Email: Kristen.Jewkes@hci.utah.edu

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute/University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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): Patients must have a detectable or rising PSA level that is > 0.05 ng/mL, with a second confirmatory level of > 0.05 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.
  • NOTE: Biopsy is not required for prostate fossa recurrences after radical prostatectomy.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Radiation: Stereotactic Body Radiation Therapy; Undergo SBRT; Other Names: SBRT; SABR; Stereotactic Ablative Body Radiation Therapy; Radiation: Hypofractionated Radiation Therapy; Undergo hypofractionated radiation therapy; Other Names: Hypofractionated Radiotherapy; hypofractionation
Experimental: Arm B (salvage oligometastasectomy); Patients with nodal metastases undergo salvage oligometastasectomy.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Procedure: Metastasectomy; Undergo salvage oligometastasectomy
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.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Radiation: Intensity-Modulated Radiation Therapy; Undergo IMRT; Other Names: IMRT; Intensity Modulated RT; Intensity-Modulated Radiotherapy; Radiation: Stereotactic Body Radiation Therapy; Undergo SBRT; Other Names: SBRT; SABR; Stereotactic Ablative Body Radiation Therapy; Radiation: Hypofractionated Radiation Therapy; Undergo hypofractionated radiation therapy; Other Names: Hypofractionated Radiotherapy; hypofractionation; Procedure: Metastasectomy; Undergo salvage oligometastasectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prostate-specific antigen (PSA) response rate	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.	At 6 months after completion of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PSA progression-free survival (PFS)	Assessed according to PCWG3 criteria. All study data will use descriptive statistics and will be exploratory only.	Time elapsed between completion of treatment (salvage + - adjuvant) and the first occurrence of confirmed PSA progression, assessed up to 3 years
Time to disease recurrence	Time from study enrollment until the date of confirmed radiographic disease progression as defined by RECIST 1.1 and PCWG3.	Time elapsed between study enrollment and first occurrence of confirmed radiographic disease progression, assessed up to 3 years
Time to antiandrogen therapy (ADT)	All study data will use descriptive statistics and will be exploratory only.	Time elapsed between study enrollment and initiation of ADT up to 3 years
Rate of undetectable PSA	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.	Up to 3 years
Incidence of adverse events	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.	Up to 3 years
Assess impact of study treatment on Change in quality of life over 3 years	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.	Up to 3 years

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Alejandro Sanchez, Huntsman Cancer Institute/ University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2019
• Primary Completion (Actual): December 12, 2023
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: January 4, 2019
• First Submitted That Met QC Criteria: January 4, 2019
• First Posted (Actual): January 8, 2019

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Neoplasms; Recurrence; Neoplasms, Second Primary
• Other Study ID Numbers: HCI115811; NCI-2018-03418 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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