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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA189295-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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The main purpose of this study is to determine if Magnetic Resonance Imaging (MRI), along with MRI targeted biopsy of suspicious lesions, is of value in detecting patients who would be likely to require treatment earlier.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Surveillance | Experimental | Participants in this group will receive a Multi-Parametric Magnetic Resonance Imaging (MP-MRI) of the prostate/pelvis and MRI-guided prostate biopsy at baseline (0-3 months from enrollment) and at the 12th, 24th and 36th month follow up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-Parametric MRI | Device | Multi-Parametric MRI |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Disease Progression Within the First Two Surveillance Biopsies | The rate of disease progression among participants within the first two surveillance biopsies will be reported. Progression refers to a repeat surveillance biopsy indicating any one of the following:
| 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time-to-Biochemical Recurrence (BCR) | Biochemical recurrence (BCR) is defined as prostate-specific antigen (PSA) of 0.2 or higher on two or more separate measures after surgery or an increase of nadir + 2ng/ml or more after radiation. Time-to-BCR is defined as duration in days between date of treatment and date of BCR, if BCR occurs. The investigators will follow participants who have progressed and gone on to treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sanoj Punnen, MD, MAS | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41985042 | Derived | Angulo-Llanos L, Cortizas EM, Williams AD, Howell NB, Guerard T, Punnen S, Masterson TA, Kava B. Evaluating the correlation between biopsy frequency and reduced sexual function in prostate cancer patients under active surveillance: a prospective cohort study. J Sex Med. 2026 Apr 9;23(5):qdag100. doi: 10.1093/jsxmed/qdag100. | |
| 40540647 | Derived | Freitas PFS, Khandekar A, Porto JG, Yu H, Williams AD, Avda Y, Malpani A, Ajami T, Mendiola DF, Soodana-Prakash N, Swain S, Gaston S, Kryvenko ON, Davicioni E, Alshalalfa M, Hao Y, Mahal B, Cortizas E, Szczotka Z, Guerard T, Kava B, Stoyanova R, Ritch CR, Nahar B, Gonzalgo ML, Pollack A, Parekh DJ, Punnen S. Can Genomic Classifiers in Biopsy Cores With Grade Group 1 Cancer Predict Higher-Grade Disease Elsewhere in the Prostate? Results From the Prospective Miami Active Surveillance Trial. J Urol. 2025 Oct;214(4):383-392. doi: 10.1097/JU.0000000000004652. Epub 2025 Jun 20. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Surveillance | Participants in this group will receive a Multi-Parametric Magnetic Resonance Imaging (MP-MRI) of the prostate/pelvis and MRI-guided prostate biopsy at baseline (0-3 months from enrollment) and at the 12th, 24th and 36th month follow up. Multi-Parametric MRI: Multi-Parametric MRI MRI-Guided Biopsy: MRI-Guided Biopsy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Surveillance | Participants in this group will receive a Multi-Parametric Magnetic Resonance Imaging (MP-MRI) of the prostate/pelvis and MRI-guided prostate biopsy at baseline (0-3 months from enrollment) and at the 12th, 24th and 36th month follow up. Multi-Parametric MRI: Multi-Parametric MRI MRI-Guided Biopsy: MRI-Guided Biopsy |
| 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 |
| 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 | Rate of Disease Progression Within the First Two Surveillance Biopsies | The rate of disease progression among participants within the first two surveillance biopsies will be reported. Progression refers to a repeat surveillance biopsy indicating any one of the following:
| Posted | Number | percentage of participants | 24 months |
|
Six years
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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 | Active Surveillance | Participants in this group will receive a Multi-Parametric Magnetic Resonance Imaging (MP-MRI) of the prostate/pelvis and MRI-guided prostate biopsy at baseline (0-3 months from enrollment) and at the 12th, 24th and 36th month follow up. Multi-Parametric MRI: Multi-Parametric MRI MRI-Guided Biopsy: MRI-Guided Biopsy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sanoj Punnen, MD | University of Miami | +1 (305) 2436596 | s.punnen@med.miami.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 | Apr 3, 2023 | May 13, 2025 | Prot_SAP_000.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 |
|---|---|
| D000081364 | Multiparametric Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
Not provided
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| MRI-Guided Biopsy |
| Device |
MRI-Guided Biopsy |
|
| Up to 36 months |
| Health-Related Quality of Life Scores: EPIC SF-12 | Health-Related Quality of Life will be assessed using scores from validated questionnaires. The Expanded Prostate Cancer Index Composite and Medical Outcomes Study Short Form-12 (EPIC SF-12) will be used to evaluate patient function and satisfaction after prostate cancer treatment. Response options for each item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL. | Up to 36 months |
| Health-Related Quality of Life Scores: MAX-PC | Health-Related Quality of Life will be assessed using scores from validated questionnaires. The Memorial Anxiety Scale for Prostate Cancer (MAX-PC) will be used to measure anxiety from pre-treatment to post-treatment. The scale consists of 18 items (e.g. "I thought about prostate cancer even though I didn't mean to.") scored on a scale from 0 ("not at all") to 3 ("often"). Total scores range from 0 to 54, with higher scores indicating higher levels of anxiety. | Up to 36 months |
| Discriminative Performance of NCCN Risk and Clinical Markers for Predicting Progression on Active Surveillance | The investigators will assess the incremental benefit of multiparametric MRI (mpMRI), genomic risk test, and molecular markers compared to baseline National Comprehensive Cancer Network (NCCN) risk classification for predicting progression on active surveillance. Area under the receiver operating characteristic Curve (ROC) curves produced from logistic regression modeling will be used to evaluate the performance of NCCN risk and other variables (MRI, genomic testing, and molecular markers) for predicting progression on surveillance. Participants will be categorized at baseline by NCCN risk class ranging from very low risk to intermediate risk; and into those who progressed while on the trial. Additionally, MRI results, PSA density, 4K score, and Decipher Score in combination with NCCN risk were analyzed to see their additive value on determining who will experience progression on active surveillance. | Up to 36 months |
| 39694787 | Derived | Kimbel IM, Wallaengen V, Zacharaki EI, Breto AL, Algohary A, Carbohn S, Gaston SM, Soodana-Prakash N, Freitas PFS, Kryvenko ON, Castillo P, Abramowitz MC, Ritch CR, Nahar B, Gonzalgo ML, Parekh DJ, Pollack A, Punnen S, Stoyanova R. HRS Improves Active Surveillance for Prostate Cancer by Timely Identification of Progression. Acad Radiol. 2025 Apr;32(4):2081-2089. doi: 10.1016/j.acra.2024.11.008. Epub 2024 Dec 17. |
| Participants |
|
| 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 |
|
|
|
| Secondary | Time-to-Biochemical Recurrence (BCR) | Biochemical recurrence (BCR) is defined as prostate-specific antigen (PSA) of 0.2 or higher on two or more separate measures after surgery or an increase of nadir + 2ng/ml or more after radiation. Time-to-BCR is defined as duration in days between date of treatment and date of BCR, if BCR occurs. The investigators will follow participants who have progressed and gone on to treatment. | Participants who underwent primary therapy for prostate cancer. | Posted | Median | Inter-Quartile Range | days | Up to 36 months |
|
|
|
| Secondary | Health-Related Quality of Life Scores: EPIC SF-12 | Health-Related Quality of Life will be assessed using scores from validated questionnaires. The Expanded Prostate Cancer Index Composite and Medical Outcomes Study Short Form-12 (EPIC SF-12) will be used to evaluate patient function and satisfaction after prostate cancer treatment. Response options for each item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL. | Posted | Median | Inter-Quartile Range | score on a scale | Up to 36 months |
|
|
|
| Secondary | Health-Related Quality of Life Scores: MAX-PC | Health-Related Quality of Life will be assessed using scores from validated questionnaires. The Memorial Anxiety Scale for Prostate Cancer (MAX-PC) will be used to measure anxiety from pre-treatment to post-treatment. The scale consists of 18 items (e.g. "I thought about prostate cancer even though I didn't mean to.") scored on a scale from 0 ("not at all") to 3 ("often"). Total scores range from 0 to 54, with higher scores indicating higher levels of anxiety. | Posted | Median | Inter-Quartile Range | score on a scale | Up to 36 months |
|
|
|
| Secondary | Discriminative Performance of NCCN Risk and Clinical Markers for Predicting Progression on Active Surveillance | The investigators will assess the incremental benefit of multiparametric MRI (mpMRI), genomic risk test, and molecular markers compared to baseline National Comprehensive Cancer Network (NCCN) risk classification for predicting progression on active surveillance. Area under the receiver operating characteristic Curve (ROC) curves produced from logistic regression modeling will be used to evaluate the performance of NCCN risk and other variables (MRI, genomic testing, and molecular markers) for predicting progression on surveillance. Participants will be categorized at baseline by NCCN risk class ranging from very low risk to intermediate risk; and into those who progressed while on the trial. Additionally, MRI results, PSA density, 4K score, and Decipher Score in combination with NCCN risk were analyzed to see their additive value on determining who will experience progression on active surveillance. | Posted | Number | probability | Up to 36 months |
|
|
|
| 2 |
| 208 |
| 5 |
| 208 |
| 8 |
| 208 |
| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chills | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cystitis noninfective | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Testicular disorder | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D003933 | Diagnosis |
| Title | Measurements |
|---|---|
|
| NCCN + Decipher Score |
|
| NCCN + 4k Score |
|