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.
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Undergo hypofractionated radiation therapy
Undergo IMRT
Undergo salvage oligometastasectomy
Ancillary studies
Ancillary studies
Undergo SBRT
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
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.
Time frame: 6 months after completion of 5-21 weeks of treatment
Prostate-specific Antigen (PSA) ≥ 50% 12 Months After Completion of All Treatment
Defined according to Prostate Cancer Working Group (PCWG3) criteria as the proportion of patients achieving a PSA decline \>= 50% at 12 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.
Time frame: 12 months after completion of 5-21 weeks of treatment
Prostate-specific Antigen (PSA) ≥ 90%
This outcome will report the count of patients achieving a PSA decline ≥ 90% 6 at 6 and12 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.
Time frame: 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
The proportion of subjects without PSA progression (defined using Prostate Cancer Working Group 3 Criteria PCWG3), evaluated every 3 months for 3 years after completion of all treatment (salvage and adjuvant therapy).
Time frame: 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.
The time from study enrollment until the date of confirmed radiographic disease progression as defined by RECIST 1.1 and PCWG3.
Time frame: 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.
The time from study enrollment to the initiation of ADT
Time frame: Up to 3 years
Undetectable PSA
This outcome measure will report the count of participants with undetectable PSA after 6 and 12 months following completion of treatment (salvage ± adjuvant). Undetectable PSA is defined as the number of patients ever treated with prostatectomy whose PSA remains ≤ 0.2 ng/mL.
Time frame: 6 and 12 months after completion of 5-21 weeks of treatment
Number of Participants With Adverse Events (AE) by Grade
This outcome measure will assess the safety and tolerability of the study treatment. The severity of AEs was assessed using CTCAE v5.0 criteria, a 1-5 scale with higher numbers indicating greater severity. Grade 1 indicates "mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated" and Grade 5 indicates "death related to AE". This outcome measure will report the count of participants who experienced each AE grade. Subjects were monitored for adverse events from the start of treatment until 28 days after the last dose of the study drug. Adverse events were collected every three months for one year after treatment discontinuation.
Time frame: Up to 12 months after completion of 5-21 weeks of treatment
Quality of Life (QOL) - The Functional Assessment of Cancer Therapy - Prostate (FACT-P)
FACT-P is a QOL questionnaires administered at the Response Assessment Visit. FACT-P is used to assess the health-related QOL in prostate cancer. Patients indicate which symptoms/problems they've experienced during the past week, from 1 Not at All to 4 Very Much. The assessment was scored according to the "FACT-P Scoring Guidelines (Version 4)". Individual items that were "reverse items" (high value indicates poor QOL) were subtracted from 4; reverse and normal items were added to calculate each subscale. The higher the subscale the better the QOL. The subscales and score ranges are: Physical Well-Being (0-28), Social/ Family Well Being (0-28), Emotional Well-Being (0-24), Functional Well Being (0-28), and Prostate Cancer Subscale (0-48) This outcome will report the mean score and 95% confidence interval of each subscale.
Time frame: up to 45 days after the initiation of study therapy
Quality of Life (QOL): Expanded Prostate Cancer Index Composite (EPIC-26)
EPIC-26 is a Health Related Quality of Life (HRQOL) questionnaires assessing the disease-specific aspects of prostate cancer and its therapies. This questionnaire asks patients to rank symptoms from 1 More than once a day to 5 Rarely or never. EPOC-26 reports 5 subscales: Urinary Incontinence Score, Urinary Obstructive/ Irritative Score, Bowel Score, Sexual Score, and Urinary Incontinence Score. Multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL.
Time frame: up to 45 days after initiation of study therapy
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