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

• ClinicalTrials.gov Identifier: NCT03796767
• Recruitment Status: Recruiting
• First Posted: January 8, 2019
• Last Update Posted: January 5, 2022
• Sponsor: University of Utah
• Information provided by (Responsible Party): University of Utah

Study Description

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 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 Design

• 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: September 9, 2019
• Estimated Primary Completion Date: December 1, 2023
• Estimated Study Completion Date: December 1, 2024

Arms and Interventions

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

Outcome Measures

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 >= 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 :

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. Time to disease recurrence [ Time Frame: Time elapsed between study enrollment and first occurrence of confirmed radiographic disease progression, assessed up to 3 years ]
   Time from study enrollment until the date of confirmed radiographic disease progression as defined by RECIST 1.1 and PCWG3.
3. Time to antiandrogen therapy (ADT) [ Time Frame: Time elapsed between study enrollment and initiation of ADT 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 ]
   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.
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.
6. Assess impact of study treatment on Change in quality of life over 3 years [ Time Frame: Up to 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.

Eligibility Criteria

• 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): 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.

Contacts and Locations

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: Alejandro Sanchez 801-587-4385 Alejandro.Sanchez@hci.utah.edu

Principal Investigator: Alejandro Sanchez

Sponsors and Collaborators

University of Utah

Investigators

• Principal Investigator: Alejandro Sanchez; Huntsman Cancer Institute/ University of Utah

More Information

• Responsible Party: University of Utah
• ClinicalTrials.gov Identifier: NCT03796767
• Other Study ID Numbers: HCI115811; NCI-2018-03418 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
• First Posted: January 8, 2019
• Last Update Posted: January 5, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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; Neoplasms, Second Primary; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Prostatic Diseases