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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA169188-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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Investigators will perform a study with 162 patients in whom there is a strong suspicion of prostate cancer that has returned to the body after having a prostatectomy. Half of these patients will have radiotherapy decision-making and delivery per the usual routine, and half of these patients will have the radiotherapy decision and volumes guided by the FACBC test (anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid (anti-3- [18F]FACBC). The major goal of the investigation is to see whether the FACBC improves the selection and the cancer control rates of post-surgery patients with a rising PSA who undergo radiotherapy.
Prostate cancer is the most common solid tumor, with approximately 200,000 new cases diagnosed per year. Several different local therapies are available for treatment, including surgery and radiotherapy Significant advances have been made in the technical aspects of surgery and of radiotherapy which have improved both the cancer control outcomes as well as the morbidity of treatment. Despite these significant advances, approximately 30% of patients treated with definitive local therapy experience recurrent disease. Recurrent disease after prostatectomy usually manifests with rising PSA (blood test for prostate cancer). The PSA level is often of limited use in differentiating local recurrence (ie. recurrence in the prostate bed) from recurrence outside of the prostate bed ( extra-prostatic recurrence).
One PET radiotracer which has shown promise in the staging and restaging of patients with prostate carcinoma is anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid (anti-3-[18F]FACBC) which is a synthetic amino acid analog. FACBC demonstrated higher accuracy compared with 111Indium-capromab-pendetide in the restaging of patients with suspected recurrent prostate carcinoma.
The major goal in this proposed investigation is to use advanced molecular imaging to better guide post-prostatectomy decision making, in terms of guiding the decision to deliver radiotherapy, and in terms of the exact areas treated with radiotherapy.
Investigators will perform a study with 162 patients in whom there is a strong suspicion of prostate cancer that has returned to the body after having a prostatectomy. Half of these patients will have radiotherapy decision-making and delivery per the usual routine, and half of these patients will have the radiotherapy decision and volumes guided by the FACBC test. The major goal of the investigation is to see whether the FACBC improves the selection and the cancer control rates of post-surgery patients with a rising PSA who undergo radiotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FACBC PET scan | Experimental | A trial group in which anti-3-[18F]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes. |
|
| Conventional-Only Imaging | Active Comparator | A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FACBC | Drug | FACBC is given intravenously prior to PET scan, radiotherapy decisions and treatment guided by PET findings |
|
| Measure | Description | Time Frame |
|---|---|---|
| Failure-free Survival | Definition of failure is: serum PSA value of 0.2ng/mL or more above the postradiotherapy nadir followed by another higher value, a continued rise in the serum PSA despite radiotherapy (RT), initiation of systemic therapy after completion of RT, or clinical progression. | 3-Year post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Decision Changes Regarding Radiotherapy Versus no Radiotherapy | Number of decision changes regarding radiotherapy versus no radiotherapy based on F-Fluciclovine PET/CT guidance. This outcome was assessed immediately after the consensus reading of the Fluciclovine PET/CT was completed by nuclear medicine, an average of 1 week post intervention. | Average of 1 week post-intervention |
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Inclusion Criteria:
Exclusion Criteria:
Contraindications to radiotherapy (including active inflammatory bowel disease or prior pelvic XRT)
Inability to undergo anti-3-[18F]FACBC PET-CT
Age under 18
Metastatic disease outside of pelvis on any imaging or biopsy
Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
Severe acute co-morbidity, defined as follows:
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| Name | Affiliation | Role |
|---|---|---|
| Ashesh B Jani, MD, MSEE | Emory University | Principal Investigator |
| David M Schuster, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33971152 | Result | Jani AB, Schreibmann E, Goyal S, Halkar R, Hershatter B, Rossi PJ, Shelton JW, Patel PR, Xu KM, Goodman M, Master VA, Joshi SS, Kucuk O, Carthon BC, Bilen MA, Abiodun-Ojo OA, Akintayo AA, Dhere VR, Schuster DM. 18F-fluciclovine-PET/CT imaging versus conventional imaging alone to guide postprostatectomy salvage radiotherapy for prostate cancer (EMPIRE-1): a single centre, open-label, phase 2/3 randomised controlled trial. Lancet. 2021 May 22;397(10288):1895-1904. doi: 10.1016/S0140-6736(21)00581-X. Epub 2021 May 7. | |
| 35417762 |
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| ID | Title | Description |
|---|---|---|
| FG000 | FACBC PET Scan | A trial group in which anti-3-[18F]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes. FACBC: FACBC is given intravenously prior to PET scan |
| FG001 | Conventional-Only Imaging | A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FACBC PET Scan | A trial group in which anti-3-[18F]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes. FACBC: FACBC is given intravenously prior to PET scan |
| BG001 | Conventional-Only Imaging |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Failure-free Survival | Definition of failure is: serum PSA value of 0.2ng/mL or more above the postradiotherapy nadir followed by another higher value, a continued rise in the serum PSA despite radiotherapy (RT), initiation of systemic therapy after completion of RT, or clinical progression. | This outcome evaluated the failure-free survival difference (among those who received radiotherapy) between the trial group (in which FACBC PET scan was used) versus the control group (in which conventional-only imaging was used). FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants. Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants. | Posted | Number | Percentage of participants | 3-Year post-intervention |
|
Up to 3-years post-intervention
Severe Adverse Events (SAEs) were defined as any provider-reported grade 3 or higher Gastrointestinal [GI] or Genitourinary [GU] toxicity. Acute toxicity was measured <90 days Post-Intervention and late toxicity was measured ≥90 days and up to 3-Years post-intervention.
Adverse Events (AE's) were defined as any provider-reported (acute or late) grade 2 toxicity.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FACBC PET Scan | A trial group in which anti-3-[18F]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes. FACBC: FACBC is given intravenously prior to PET scan |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematuria - Acute | Renal and urinary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ashesh Jani | Emory University | 404-778-3827 | abjani@emory.edu |
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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 | Feb 24, 2017 | Mar 27, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 7, 2018 | Apr 10, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C117460 | fluciclovine F-18 |
| D011878 | Radiotherapy |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
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| Radiation therapy | Radiation | External beam radiotherapy to prostate bed +/- pelvic lymph nodes; final dose of 66.6 Gy. |
|
|
| Decision Changes Regarding Whole-pelvis Versus Local Fields | Number of decision changes regarding whole-pelvis versus local fields. This outcome was assessed immediately after the consensus reading of the Fluciclovine PET/CT was completed by nuclear medicine, an average of 1 week post intervention. | Average of 1 week post-intervention |
| Total Number of Decision Changes | Total number of radiotherapy decision changes regarding radiotherapy vs no radiotherapy and regarding whole pelvis vs local fields. This outcome was assessed immediately after the consensus reading of the Fluciclovine PET/CT was completed by nuclear medicine, an average of 1 week post intervention. | Average of 1 week post-intervention |
| Prostate Bed Clinical Target Volume (CTV) | Absolute volume pre- vs post-PET. This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention. | Average of 1 month post-intervention |
| Prostate Bed Planning Target Volume (PTV) | Absolute volume were measured pre- vs post-PET. This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention. | Average of 1 month post-intervention |
| PTV Dosimetric Endpoints | Standard radiotherapy dosimetric endpoints used to evaluate target coverage. Planning target volume (PTV) at V100 and V110 refer to %volume of the structure receiving 100% and 110% of the prescription dose, respectively, pre and post positron emission tomography (PET). This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention. | Average of 1 month post-intervention |
| Rectum Dosimetric Endpoints | Standard radiotherapy dosimetric endpoints used to evaluate normal tissue doses, in this case, the rectum. V40 and V65 refer to the %volume of the structure receiving 40 Gy and 65 Gy, respectively, pre and post positron emission tomography (PET) volumes were compared. This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention. | Average of 1 month post-intervention |
| Bladder Dosimetric Endpoints | Standard radiotherapy dosimetric endpoints are used to evaluate normal tissue doses, in this case, the bladder. V40 and V65 refer to the %volume of the structure receiving 40 Gy and 65 Gy, respectively, pre and post positron emission tomography (PET) volumes were compared. This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention. | Average of 1 month post-intervention |
| Rate of ≥ Grade 2 GU (Genitourinary [Renal or Urinary]) Toxicity | Provider-reported maximum acute (<90 days Post-Intervention) and late (≥90 days and up to 3-Years post-intervention) genitourinary toxicity based on CTCAE v4.0 criteria. | 3-Year post-intervention |
| Rate of ≥ Grade 2 GI (Gastrointestinal) Toxicity | Provider-reported maximum acute (<90 days Post-Intervention) and late (≥90 days and up to 3-Years post-intervention) gastrointestinal toxicity ≥ Grade 2 based on CTCAE v4.0 criteria. | 3-Year post-intervention |
| Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC) GU (Genitourinary) Domain Score | Patient-reported maximum genitourinary toxicity based on standard EPIC-CP questionnaire. EPIC GU domain score has a total score range 0-12. Higher score correlates with worse outcome. EPIC GU score includes the incontinence domain score and the irritative/obstructive. | 3-Year post-intervention |
| Expanded Prostate Cancer Index Composite (EPIC) GI (Gastrointestinal) Domain Score | Patient-reported maximum gastrointestinal toxicity based on standard EPIC-CP questionnaire. Total score range 0-12. Higher score correlates with worse outcome. | 3-Year post-intervention |
| Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain Score | Patient-reported maximum sexual function toxicity based on standard EPIC-CP questionnaire. Total score range 0-12. Higher score correlates with worse outcome. | 3-Year post-intervention |
| Expanded Prostate Cancer Index Composite (EPIC) Total Score | Patient-reported maximum overall (genitourinary, gastrointestinal, and sexual function) toxicity based on standard EPIC-CP questionnaire. Total score range 0-60. Higher score correlates with worse outcome. | 3-Year post-intervention |
| Result |
| Dhere VR, Schuster DM, Goyal S, Schreibmann E, Hershatter BW, Rossi PJ, Shelton JW, Patel PR, Jani AB. Randomized Trial of Conventional Versus Conventional Plus Fluciclovine (18F) Positron Emission Tomography/Computed Tomography-Guided Postprostatectomy Radiation Therapy for Prostate Cancer: Volumetric and Patient-Reported Analyses of Toxic Effects. Int J Radiat Oncol Biol Phys. 2022 Aug 1;113(5):1003-1014. doi: 10.1016/j.ijrobp.2022.04.005. Epub 2022 Apr 11. |
| No radiotherapy given, due to extrapelvic uptake on PET scan |
|
A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Gleason score ≥8 | Pathological grade was measured on the prostatectomy specimen. Gleason Grading goes from 2 thru 10, with higher scores being worse prognostically. Gleason scores of 8 and higher are considered high-grade, so this measure was designed to see whether the percentage of high-grade patients was balanced. | Count of Participants | Participants |
|
| Ave PSA before radiotherapy | Median | Inter-Quartile Range | ng/mL |
|
| OG001 | Conventional-Only Imaging | A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan. |
|
|
| Secondary | Decision Changes Regarding Radiotherapy Versus no Radiotherapy | Number of decision changes regarding radiotherapy versus no radiotherapy based on F-Fluciclovine PET/CT guidance. This outcome was assessed immediately after the consensus reading of the Fluciclovine PET/CT was completed by nuclear medicine, an average of 1 week post intervention. | This outcome evaluated number of decision changes regarding the overall use of radiotherapy in the FACBC PET scan group only. | Posted | Number | Number of decision changes | Average of 1 week post-intervention |
|
|
|
| Secondary | Decision Changes Regarding Whole-pelvis Versus Local Fields | Number of decision changes regarding whole-pelvis versus local fields. This outcome was assessed immediately after the consensus reading of the Fluciclovine PET/CT was completed by nuclear medicine, an average of 1 week post intervention. | This outcome evaluated number of decision changes regarding changes from whole-pelvis to local fields and vice versa (local fields to whole pelvis) in the FACBC PET scan group only. | Posted | Number | Number of decision changes | Average of 1 week post-intervention |
|
|
|
| Secondary | Total Number of Decision Changes | Total number of radiotherapy decision changes regarding radiotherapy vs no radiotherapy and regarding whole pelvis vs local fields. This outcome was assessed immediately after the consensus reading of the Fluciclovine PET/CT was completed by nuclear medicine, an average of 1 week post intervention. | This outcome evaluated number of all radiotherapy-related decision changes in the FACBC PET scan group only. | Posted | Number | Number of decision changes | Average of 1 week post-intervention |
|
|
|
| Secondary | Prostate Bed Clinical Target Volume (CTV) | Absolute volume pre- vs post-PET. This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention. | Note that no participants were analyzed in the Conventional group Post-PET since they did not receive the PET intervention. FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants. Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants. | Posted | Mean | Standard Deviation | mL | Average of 1 month post-intervention |
|
|
|
| Secondary | Prostate Bed Planning Target Volume (PTV) | Absolute volume were measured pre- vs post-PET. This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention. | Note that no participants were analyzed in the Conventional group Post-PET since they did not receive the PET intervention. FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants. Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants. | Posted | Mean | Standard Deviation | mL | Average of 1 month post-intervention |
|
|
|
| Secondary | PTV Dosimetric Endpoints | Standard radiotherapy dosimetric endpoints used to evaluate target coverage. Planning target volume (PTV) at V100 and V110 refer to %volume of the structure receiving 100% and 110% of the prescription dose, respectively, pre and post positron emission tomography (PET). This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention. | Note that no participants were analyzed in the Conventional group Post-PET since they did not receive the PET intervention. FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants. Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants. | Posted | Mean | Standard Deviation | percentage of volume | Average of 1 month post-intervention |
|
|
|
| Secondary | Rectum Dosimetric Endpoints | Standard radiotherapy dosimetric endpoints used to evaluate normal tissue doses, in this case, the rectum. V40 and V65 refer to the %volume of the structure receiving 40 Gy and 65 Gy, respectively, pre and post positron emission tomography (PET) volumes were compared. This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention. | Note that no participants were analyzed in the Conventional group Post-PET since they did not receive the PET intervention. FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants. Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants. | Posted | Mean | Standard Deviation | percentage of volume | Average of 1 month post-intervention |
|
|
|
| Secondary | Bladder Dosimetric Endpoints | Standard radiotherapy dosimetric endpoints are used to evaluate normal tissue doses, in this case, the bladder. V40 and V65 refer to the %volume of the structure receiving 40 Gy and 65 Gy, respectively, pre and post positron emission tomography (PET) volumes were compared. This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention. | Note that no participants were analyzed in the Conventional group Post-PET since they did not receive the PET intervention. FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants. Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants. | Posted | Mean | Standard Deviation | percentage of volume | Average of 1 month post-intervention |
|
|
|
| Secondary | Rate of ≥ Grade 2 GU (Genitourinary [Renal or Urinary]) Toxicity | Provider-reported maximum acute (<90 days Post-Intervention) and late (≥90 days and up to 3-Years post-intervention) genitourinary toxicity based on CTCAE v4.0 criteria. | All patients in both the FACBC PET scan and the Conventional-imaging only groups. | Posted | Count of Participants | Participants | 3-Year post-intervention |
|
|
|
| Secondary | Rate of ≥ Grade 2 GI (Gastrointestinal) Toxicity | Provider-reported maximum acute (<90 days Post-Intervention) and late (≥90 days and up to 3-Years post-intervention) gastrointestinal toxicity ≥ Grade 2 based on CTCAE v4.0 criteria. | All patients in both the FACBC PET scan and the Conventional-imaging only groups. | Posted | Count of Participants | Participants | 3-Year post-intervention |
|
|
|
| Secondary | Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC) GU (Genitourinary) Domain Score | Patient-reported maximum genitourinary toxicity based on standard EPIC-CP questionnaire. EPIC GU domain score has a total score range 0-12. Higher score correlates with worse outcome. EPIC GU score includes the incontinence domain score and the irritative/obstructive. | Radiotherapy-treated patients in both the FACBC PET scan and the Conventional-imaging only groups. FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants. Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants. | Posted | Mean | Standard Deviation | score on a scale | 3-Year post-intervention |
|
|
|
| Secondary | Expanded Prostate Cancer Index Composite (EPIC) GI (Gastrointestinal) Domain Score | Patient-reported maximum gastrointestinal toxicity based on standard EPIC-CP questionnaire. Total score range 0-12. Higher score correlates with worse outcome. | Radiotherapy-treated patients in both the FACBC PET scan and the Conventional-imaging only groups. FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants. Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants. | Posted | Mean | Standard Deviation | score on a scale | 3-Year post-intervention |
|
|
|
| Secondary | Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain Score | Patient-reported maximum sexual function toxicity based on standard EPIC-CP questionnaire. Total score range 0-12. Higher score correlates with worse outcome. | Radiotherapy-treated patients in both the FACBC PET scan and the Conventional-imaging only groups. FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants. Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants. | Posted | Mean | Standard Deviation | score on a scale | 3-Year post-intervention |
|
|
|
| Secondary | Expanded Prostate Cancer Index Composite (EPIC) Total Score | Patient-reported maximum overall (genitourinary, gastrointestinal, and sexual function) toxicity based on standard EPIC-CP questionnaire. Total score range 0-60. Higher score correlates with worse outcome. | Radiotherapy-treated patients in both the FACBC PET scan and the Conventional-imaging only groups. FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants. Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants. | Posted | Mean | Standard Deviation | score on a scale | 3-Year post-intervention |
|
|
|
| 1 |
| 83 |
| 5 |
| 83 |
| 71 |
| 83 |
| EG001 | Conventional-Only Imaging | A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan. | 1 | 82 | 8 | 82 | 76 | 82 |
| Hematuria - Late | Renal and urinary disorders | Systematic Assessment |
|
| Urinary Frequency | Renal and urinary disorders | Systematic Assessment |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| Post-PET |
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| Post-PET |
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| PTV2/PTV, V100% post PET |
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| PTV2/PTV, V110% pre PET |
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| PTV2/PTV, V110% post PET |
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| Rectum, V40 post PET |
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| Rectum, V65 pre PET |
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| Rectum, V65 post PET |
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| Bladder, V40 post-PET |
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| Bladder, V65 pre-PET |
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| Bladder, V65 post-PET |
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