Salvage Oligometastasectomy and Radiation Therapy in Recurrent Prostate Cancer

NCT03796767 | Active Not Recruiting Phase 2 Results DMC

• 2 other identifiers: HCI115811NCI-2018-03418
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Prostate-specific Antigen (PSA) ≥ 50% 6 Months After Completion of All Treatment

  The primary outcome measure will report the count of patients achieving a PSA decline \>= 50% at 6 months after completion of treatment (salvage + - adjuvant). Prostate-Specific Antigen (PSA) is a protein produced by tissue in the prostate. An elevated PSA value can be a sign of prostate cancer.

  6 months after completion of 5-21 weeks of treatment

Secondary Outcomes (9)

• Prostate-specific Antigen (PSA) ≥ 50% 12 Months After Completion of All Treatment

  12 months after completion of 5-21 weeks of treatment

• Prostate-specific Antigen (PSA) ≥ 90%

  6 and 12 months after completion of 5-21 weeks of treatment 6 Months After Completion of All Treatment6 Months After Completion of All Treatment

• PSA Progression Free-survival

  Time elapsed between study enrollment and first occurrence of confirmed radiographic disease progression, assessed up to 3 years

• To Assess Time to Disease Recurrence Following Treatment of Oligometastatic Disease.

  Time elapsed between study enrollment and confirmed radiographic disease progression, up to 3 years

• To Assess Time to Initiation of ADT for Metastatic Prostate Cancer Following Treatment of Oligometastatic Disease.

  Up to 3 years

Study Arms (3)

Arm A (radiation therapy)

EXPERIMENTAL

Patients with bone metastases undergo SBR) or hypofractionated radiation per institutional standard of care guidelines at investigator's discretion.

Radiation: Hypofractionated Radiation Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Stereotactic Body Radiation Therapy

Arm B (salvage oligometastasectomy)

EXPERIMENTAL

Patients with nodal metastases undergo salvage oligometastasectomy.

Procedure: Metastasectomy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm C (salvage oligometastasectomy, radiation therapy)

EXPERIMENTAL

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; Radiation: Intensity-Modulated Radiation Therapy; Procedure: Metastasectomy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Stereotactic Body Radiation Therapy

Interventions

Metastasectomy PROCEDURE

Undergo salvage oligometastasectomy

Arm B (salvage oligometastasectomy); Arm C (salvage oligometastasectomy, radiation therapy)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm A (radiation therapy); Arm B (salvage oligometastasectomy); Arm C (salvage oligometastasectomy, radiation therapy)

Hypofractionated Radiation Therapy RADIATION

Undergo hypofractionated radiation therapy

Also known as: Hypofractionated Radiotherapy, hypofractionation

Arm A (radiation therapy); Arm C (salvage oligometastasectomy, radiation therapy)

Intensity-Modulated Radiation Therapy RADIATION

Undergo IMRT

Also known as: IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy

Arm C (salvage oligometastasectomy, radiation therapy)

Questionnaire Administration OTHER

Ancillary studies

Arm A (radiation therapy); Arm B (salvage oligometastasectomy); Arm C (salvage oligometastasectomy, radiation therapy)

Stereotactic Body Radiation Therapy RADIATION

Undergo SBRT

Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

Arm A (radiation therapy); Arm C (salvage oligometastasectomy, radiation therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Lymphatic Metastasis

Interventions

Radiation Dose Hypofractionation; Radiotherapy, Intensity-Modulated; Metastasectomy; Radiosurgery

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Surgical Procedures, Operative; Stereotaxic Techniques; Neurosurgical Procedures; Investigative Techniques

Results Point of Contact

• Title: IIT Data Management Team
• Organization: Research Compliance Office, Huntsman Cancer Institute

IITDataManagement@hci.utah.edu

801-213-6215

Study Officials

• Alejandro Sanchez

  Huntsman Cancer Institute/ University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: January 8, 2019
• Study Start: September 9, 2019
• Primary Completion: February 13, 2024
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 28, 2026
• Results First Posted: October 20, 2025

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)