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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-03418 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (radiation therapy) | Experimental | Patients with bone metastases undergo SBR) or hypofractionated radiation per institutional standard of care guidelines at investigator's discretion. |
|
| Arm B (salvage oligometastasectomy) | Experimental | Patients with nodal metastases undergo salvage oligometastasectomy. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated Radiation Therapy | Radiation | Undergo hypofractionated radiation therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Histologically proven adenocarcinoma of the prostate.
Recurrent prostate carcinoma after definitive therapy for primary disease defined as:
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:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Alejandro Sanchez | Huntsman Cancer Institute/ University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A (Radiation Therapy) | Patients with bone metastases undergo SBR) or hypofractionated radiation per institutional standard of care guidelines at investigator's discretion. Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Stereotactic Body Radiation Therapy: Undergo SBRT |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 10, 2021 |
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|
| Intensity-Modulated Radiation Therapy | Radiation | Undergo IMRT |
|
|
| Metastasectomy | Procedure | Undergo salvage oligometastasectomy |
|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
|
| Questionnaire Administration | Other | Ancillary studies |
|
| Stereotactic Body Radiation Therapy | Radiation | Undergo SBRT |
|
|
| 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. | 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 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 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 | 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. | 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. | 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. | 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. | up to 45 days after initiation of study therapy |
| FG001 | Arm B (Salvage Oligometastasectomy) | Patients with nodal metastases undergo salvage oligometastasectomy. Metastasectomy: Undergo salvage oligometastasectomy Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
| FG002 | 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. Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy Intensity-Modulated Radiation Therapy: Undergo IMRT Metastasectomy: Undergo salvage oligometastasectomy Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Stereotactic Body Radiation Therapy: Undergo SBRT |
| COMPLETED |
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| NOT COMPLETED |
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No participants were enrolled in Arm C.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A (Radiation Therapy) | Patients with bone metastases undergo SBR) or hypofractionated radiation per institutional standard of care guidelines at investigator's discretion. Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Stereotactic Body Radiation Therapy: Undergo SBRT |
| BG001 | Arm B (Salvage Oligometastasectomy) | Patients with nodal metastases undergo salvage oligometastasectomy. Metastasectomy: Undergo salvage oligometastasectomy Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
| BG002 | 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. Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy Intensity-Modulated Radiation Therapy: Undergo IMRT Metastasectomy: Undergo salvage oligometastasectomy Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Stereotactic Body Radiation Therapy: Undergo SBRT |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Height | Mean | Standard Deviation | cm |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| BMI | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| PSA at Time of Initial Definitive Treatment | Prostate-Specific Antigen (PSA) is a protein produced by tissue in the prostate. An elevated PSA value can be a sign of prostate cancer. | Mean | Standard Deviation | ng/mL |
| ||||||||||||||
| Number of Nodal Lesions Present | Nodal lesions in prostate cancer are lymph nodes near the prostate that contain cancer cells. | Mean | Full Range | Lesions |
| ||||||||||||||
| ECOG | Eastern Cooperative Oncology Group (ECOG) is a common oncology metric used to describe a patient's level of functioning. | Count of Participants | Participants |
| |||||||||||||||
| Histology | Adenocarcinoma of the prostate is a malignant tumor from the glands in the prostate. This will report patients who had histologically proven adenocarcinoma of the prostate only or of the prostate and secondary histology | Count of Participants | Participants |
| |||||||||||||||
| Total Gleason at Definitive Treatment | Total Gleason scores are prostate cancer grading systems based on microscopy of tissue samples. Scores range from 6 to 10, with lower scores indicating lower grade cancer and higher scores indicating higher grade cancer. | Count of Participants | Participants |
| |||||||||||||||
| T Stage | Measure Description: With the Tumor Node Metastasize (TNM) system, the T Stage describes the extent of the main tumor. T2: Organ confined T2a: Tumor spread to ≤ half of one side of the prostate T2b: Tumor spread to > half of one side of the prostate T2c: Tumor spread to both sides of the prostate T3: Extraprostatic extension T3a: Extraprostatic extension (unilateral or bilateral) or microscopic invasion of bladder neck T3b: Tumor invades seminal vesicle(s) T4: Tumor is fixed or invades adjacent structures other than seminal vesicles | Count of Participants | Participants |
| |||||||||||||||
| N Stage | With the Tumor Node Metastasize (TNM) system, the N Stage describes if cancer spread to nearby lymph nodes. NX: Regional lymph nodes cannot be assessed N0: No positive regional nodes N1: Metastases in regional node(s) | Count of Participants | Participants |
| |||||||||||||||
| M Stage | With the Tumor Node Metastasize (TNM) system, the M Stage describes if cancer spread (metastasized) to other parts of the body. M0: No distant metastasis M1: Distant metastasis M1a: Nonregional lymph node(s) M1b: Bone(s) M1c: Other site(s) with or without bone disease | Count of Participants | Participants |
| |||||||||||||||
| Overall Stage | In the Tumor Node Metastasize (TNM) system, overall stage is the extent of cancer based on 5 items:
Stage IIB (T1-2, N0, M0, PSA <20, Grade 2) Stage IIIA (T1-2, N0, M0, PSA >=20, Grade 1-4) Stage IIIB (T3-4, N0, M0, Any PSA, Grade 1-4) Stage IIIC (Any T, N0, M0, Any PSA, Grade 5) Stage IVA (Any T, N1, M0, Any PSA, Any Grade) Stage IVB (Any T, Any N, M1, Any PSA, Any Grade) | Count of Participants | Participants |
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| Prior radiotherapy | Radiotherapy (or Radiation therapy) is used to kill cancer cells and shrink tumors with high doses of radiation. | Count of Participants | Participants |
| |||||||||||||||
| Prior exposer to Androgen deprivation therapy (ADT) | ADT is a medication that reduces the amount of androgens in the body. This is used as a treatment for prostate cancer as androgens are important for prostate cancer cell growth. Hence, ADT can slow the cancer's progression. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | No participants were enrolled in Arm C. | Posted | Count of Participants | Participants | 6 months after completion of 5-21 weeks of treatment |
|
|
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| Secondary | 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. | No participant was enrolled on Arm C | Posted | Count of Participants | Participants | 12 months after completion of 5-21 weeks of treatment |
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| Secondary | 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. | No participants were enrolled in Arm C. | Posted | Count of Participants | Participants | 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 |
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| Secondary | 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). | Not Posted | Apr 2026 | Time elapsed between study enrollment and first occurrence of confirmed radiographic disease progression, assessed up to 3 years | Participants | ||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Apr 2026 | Time elapsed between study enrollment and confirmed radiographic disease progression, up to 3 years | Participants | ||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Not Posted | Apr 2026 | Up to 3 years | Participants | ||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | No participants were enrolled in Arm C | Posted | Count of Participants | Participants | 6 and 12 months after completion of 5-21 weeks of treatment |
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| Secondary | 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. | No participants were enrolled in Arm C. | Posted | Count of Participants | Participants | Up to 12 months after completion of 5-21 weeks of treatment |
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| Secondary | 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. | 1 participant did not complete this assessment in Arm A. 10 participants did not complete this assessment in Arm B. No participants were enrolled in Arm C. | Posted | Mean | 95% Confidence Interval | units on a scale | up to 45 days after the initiation of study therapy |
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| Secondary | 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. | 1 participant did not complete this assessment in Arm A. 10 participants did not complete this assessment in Arm B. No participants were enrolled in Arm C. | Posted | Mean | 95% Confidence Interval | units on a scale | up to 45 days after initiation of study therapy |
|
Collection of adverse events began with the first study salvage treatment (surgery OR radiotherapy for bone metastases) and ended 1 year after the last study treatment (including palliative radiotherapy if applicable) or until a new cancer treatment was initiated, up to 1 year.
No participants were enrolled in Arm C.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A (Radiation Therapy) | Patients with bone metastases undergo SBR) or hypofractionated radiation per institutional standard of care guidelines at investigator's discretion. Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Stereotactic Body Radiation Therapy: Undergo SBRT | 0 | 2 | 0 | 2 | 2 | 2 |
| EG001 | Arm B (Salvage Oligometastasectomy) | Patients with nodal metastases undergo salvage oligometastasectomy. Metastasectomy: Undergo salvage oligometastasectomy Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies | 0 | 18 | 0 | 18 | 12 | 18 |
| EG002 | 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. Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy Intensity-Modulated Radiation Therapy: Undergo IMRT Metastasectomy: Undergo salvage oligometastasectomy Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Stereotactic Body Radiation Therapy: Undergo SBRT | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dysuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Edema limbs | General disorders | Systematic Assessment |
| ||
| Erectile dysfunction | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Esophageal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Flank pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| General disorders and administration site conditions - Other, specify | General disorders | Systematic Assessment |
| ||
| Genital edema | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Hematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nervous system disorders - Other, specify | Nervous system disorders | Systematic Assessment |
| ||
| Non-cardiac chest pain | General disorders | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Paresthesia | Nervous system disorders | Systematic Assessment |
| ||
| Perineal pain | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Surgical and medical procedures - Other, specify | Surgical and medical procedures | Systematic Assessment |
| ||
| Urinary incontinence | Renal and urinary disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| IIT Data Management Team | Research Compliance Office, Huntsman Cancer Institute | 801-213-6215 | IITDataManagement@hci.utah.edu |
| Feb 18, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D008207 | Lymphatic Metastasis |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069473 | Radiation Dose Hypofractionation |
| D050397 | Radiotherapy, Intensity-Modulated |
| D059146 | Metastasectomy |
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D019583 | Dose Fractionation, Radiation |
| D011879 | Radiotherapy Dosage |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D013514 | Surgical Procedures, Operative |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D008919 | Investigative Techniques |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 1 Restricted |
|
| 2 Ambulatory |
|
| 3 Limited selfcare |
|
| 4 Completely disabled |
|
| 5 Dead |
|
| Adenocarcinoma of the prostate + secondary histology |
|
| 7 |
|
| 8 |
|
| 9 |
|
| T2a |
|
| T2b |
|
| T2c |
|
| T3 |
|
| T3a |
|
| T3b |
|
| N0 |
|
| N1 |
|
| Unknown / Not assessed |
|
| M1 |
|
| Unknown / Not assessed |
|
| Stage IIIA |
|
| Stage IIIB |
|
| Stage IIIC |
|
| Stage IVA |
|
| Stage IVB |
|
| Unknown / Not assessed |
|
| Definitive Radiotherapy - Prostate (should be salvage radiation - prostate) |
|
| Adjuvant/Salvage Radiotherapy - Prostate |
|
| Adjuvant/Salvage Radiotherapy - Pelvis + Prostate |
|
| No |
|
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. Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy Intensity-Modulated Radiation Therapy: Undergo IMRT Metastasectomy: Undergo salvage oligometastasectomy Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Stereotactic Body Radiation Therapy: Undergo SBRT |
|
|
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. Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy Intensity-Modulated Radiation Therapy: Undergo IMRT Metastasectomy: Undergo salvage oligometastasectomy Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Stereotactic Body Radiation Therapy: Undergo SBRT |
|
|
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.
Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Intensity-Modulated Radiation Therapy: Undergo IMRT
Metastasectomy: Undergo salvage oligometastasectomy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Stereotactic Body Radiation Therapy: Undergo SBRT
|
|
| OG002 | 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. Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy Intensity-Modulated Radiation Therapy: Undergo IMRT Metastasectomy: Undergo salvage oligometastasectomy Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Stereotactic Body Radiation Therapy: Undergo SBRT |
|
|
| OG001 |
| Arm B (Salvage Oligometastasectomy) |
Patients with nodal metastases undergo salvage oligometastasectomy. Metastasectomy: Undergo salvage oligometastasectomy Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
| OG002 | 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. Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy Intensity-Modulated Radiation Therapy: Undergo IMRT Metastasectomy: Undergo salvage oligometastasectomy Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Stereotactic Body Radiation Therapy: Undergo SBRT |
|
|
| OG002 | 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. Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy Intensity-Modulated Radiation Therapy: Undergo IMRT Metastasectomy: Undergo salvage oligometastasectomy Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Stereotactic Body Radiation Therapy: Undergo SBRT |
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