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Prostatic Neoplasms

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Genital Neoplasms, Male

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Genital Diseases, Male

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Prostatic Diseases

Male Urogenital Diseases

Disease Attributes

Active surveillance (AS) with the following: a) Initial PSA and DRE screen; then, PSA screening every 12 months, with DRE every year mpMRI or prostate biopsy is performed; b) Initial mpMRI and then prior to all biopsies; c) Initial systemic prostate biopsy and MRI/US fusion-guided prostate biopsy of all suspicious lesions; then, every 2 years for 5 years and then every 3 years

3T endorectal coil MR imaging of the prostate gland

mpMRI

Karen Holcomb

Peter A Pinto, M.D.

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

Background:

Active surveillance (AS) is a standard approach to treat low and intermediate risk prostate cancer. For AS, disease progression is monitored. AS uses biopsies, prostate specific antigen (PSA) blood tests, and other tools. Researchers want to see if multiparametric magnetic resonance imaging (mpMRI) can help improve AS.

Objective:

To see if mpMRI can improve how people are monitored during AS.

Eligibility:

Men age 18 and older who have been diagnosed with prostate cancer within the last 2 years.

Design:

Participants will undergo AS. Their PSA level will be checked once a year via blood test. They will have a digital rectal exam once a year.

Participants will have biopsies every 2-3 years. Needles will be put into different parts of the prostate. The needles are guided by ultrasound imaging.

Participants will also have targeted biopsies with mpMRI and MRI guided fusion (MRI-US fusion). MRI-US fusion combines previous MRI images with live ultrasound images. For MRIs, participants will lie on their stomach on the scanner table. A coil may be placed in the rectum.

Participants will have a physical exam and medical record review at least every 3 years. Their weight and vital signs will be checked. They will give data about their daily activities, side effects, and symptoms.

Every 2-3 years, participants will fill out surveys about their prostate health and quality of life.

Participants may give blood, urine, prostate secretion, and saliva samples. The samples will be used for research.

Participation will last for as long as the participant does not need actual treatment for his prostate cancer.

Background:

* Active Surveillance (AS) is a standard approach in the treatment of low and intermediate risk prostate cancer which employs a strategy of monitoring the clinical progression of prostate cancer.
* AS utilizes prostate biopsies, prostate specific antigen (PSA), and digital rectal examinations (DRE) as tools to determine clinical progression in prostate cance
* This protocol aims to assess an additional tool, multiparametric magnetic resonance imaging (mpMRI) to actively visualize and monitor disease within the prostate in addition to standard instruments used to determine clinical progression of disease.

Objectives:

* To determine the role of mpMRI in the selection and management of participants for AS by correlating imaging findings with pathological progression as determined on serial biopsies.
* To determine the optimal interval of MR imaging in monitoring AS participants for evidence of progression by correlating sequential MRIs with biopsies with the goal to reduce unnecessary imaging.
* To evaluate the relationship between mpMRI, prostate biopsy pathology results, and progression in AS participants to determine if prostate biopsies may be safely avoided based on the accuracy of imaging (sensitivity and specificity).

Eligibility:

* Men, 18 years and older with biopsy confirmed prostate cancer
* Gleason Score which less than or equal to 3+4=7
* Initial diagnosis of prostate cancer within 2 years of study entry
* Capable of being consented to the protocol

Design:

* Single arm, prospective, cohort study to correlate mpMRI with prostate biopsy pathology.
* We plan to accrue 508 participants over the entire study period, assuming about a 10% dropout to allow adequate statistical review.
* Participants will be monitored for clinical progression of their prostate cancer with PSA, DRE, mpMRI, and prostate biopsy (systematic and MRI lesion targeted) as follows:

  * Initial prostate cancer antigen (PSA) screening with an additional PSA screen every 12 months
  * Initial DRE screening with additional DRE to be performed every year that either prostate MRI or biopsy is performed
  * Initial mpMRI and prior to each biopsy (i.e., mandated at least every two years until year five, and then every three years thereafter)
  * Initial systematic 12-Core prostate biopsy and MRI guided fusion (MRI-US fusion) prostate biopsy of all suspicious lesions (i.e., targeted biopsy). Future biopsies, including 12-core systematic and targeted biopsy (to be performed in the same session) will then be mandated every two years until year five at which time biopsies will be performed every three years thereafter unless contraindicated.
  * mpMRI and biopsies may be performed earlier if clinically indicated and will revert back to previous mpMRI/biopsy schedule after.
  * Biopsy pathology results will be used as the standard for diagnosis of clinical progression.

Multiparametric Magnetic Resonance Imaging of the Prostate to Assess Disease Progression and Genomics in Patients Undergoing Active Surveillance for Prostate Cancer

.All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGAP

role of mpMRI in the selection and management of patients for AS by correlating imaging findings with pathological progression as determined on serial biopsies

relationship between mpMRI, prostate biopsy pathology results, and progression in AS patients to determine if prostate biopsies may be safely avoided based on the accuracy of imaging (sensitivity and specificity) to avoid progression

optimal interval of MR imaging in monitoring AS patients for evidence of progression by correlating sequential MRIs with biopsies with the goal to reduce unnecessary imaging

determine if MR imaging is superior to PSA and digital rectal exam (DRE) in predicting biopsy findings of progression in AS patients

National Cancer Institute (NCI)

All Drugs and Chemicals

Hormones

Chemotherapy

In men with prostate cancer who do not have evidence of spread to bone or other sites on computed axial tomography (CAT) scan/bone scan but are still at significant risk of failing treatment with surgery or radiation alone, a combination of chemotherapy and hormone therapy is being given for 6 months followed by surgery to remove the prostate.

Chemotherapy, Hormone Therapy, and Surgery to Remove the Prostate Gland in Patients With High Risk Prostate Cancer

Chemohormone Therapy Prior to Prostatectomy in High Risk Prostate Cancer

US Department of Veterans Affairs

Samples and images from up to 277 evaluable patients diagnosed with NCCN low or intermediate risk prostate cancer, Gleason \<= 7, managed with RP, and mpMRI within 6 months prior to prostatectomy

Background:

Prostate cancer is one of the most common cancers in men. For some men, their cancer is monitored. Others have surgery to remove the prostate. Focal therapy is another treatment option. It treats the areas of cancer selectively, which leaves the rest of the prostate intact. This can help lessen side effects. Men who get focal therapy must be chosen carefully. The Oncotype DX Genomic Prostate Score (GPS) assay tests biopsy samples for certain cancer-related genes. It then then gives a score from 1 to 100 to predict the likelihood of poor outcomes. The GPS is used to choose men for focal therapy. Researchers want to test the GPS further.

Objective:

To assess how GPS may be useful when used with MRI to improve how men are chosen for focal therapy of prostate cancer.

Eligibility:

Men age 18 and older who had NCCN low or intermediate risk prostate cancer and had MRI and radical prostatectomy at the Urologic Oncology Branch, National Cancer Institute and collaborating centers.

Design:

This is a multisite study. It will review data and samples that were collected in the past. Samples and images from up to 277 participants will be used.

Tumor tissue will be tested with the GPS.

Data such as age at diagnosis, race, biopsy results, and pathology results will be merged with the GPS results.

Data will be entered into an in-house electronic system. It will be password protected. All data will be kept in secure sites that comply with NIH security standards.

Background:

* Prostate cancer is one of the most common malignancies occurring in men. While many men will qualify for active surveillance (AS), those with intermediate risk disease are often recommended definitive therapy despite the morbidity.
* Focal therapy for prostate cancer has been promoted as an alternative to the standard paradigm of immediate radical prostatectomy (RP) versus AS for prostate cancer management. Focal therapy treats the areas of cancer selectively, leaving the remainder of the prostate intact.
* While focal therapy offers great promise in terms of minimizing side effects and helping prostate cancer patients avoid radical therapies, careful patient selection is required.
* The Oncotype DX Genomic Prostate Score (GPS) assay was developed using the ability to extract and amplify RNA of sufficient quantity and quality from the very small amounts of prostate tumor tissue from biopsy samples. Using these samples, a discovery study identified 12 cancerrelated genes associated with multiple clinically relevant endpoints including adverse pathology, biochemical recurrence, clinical recurrence, and prostate cancer associated death.
* The GPS assay uses these 12 genes and 5 reference genes to construct an algorithm giving a score from 0-100 to predict the likelihood of adverse pathology.
* The goal of this study is to evaluate how GPS may be useful in conjunction with MRI to improve patient selection for focal therapy of prostate cancer.

Objectives:

-To determine if there is a positive association between continuous GPS score and occult high risk and/or non-organ confined disease on whole mount prostatectomy specimens where an MRI was performed less than 6 months before diagnostic biopsy, and the biopsy was less than 6 months before RP and the lesion was not identified on multiparameter MRI (mpMRI)

Eligibility:

* Samples and images from men, over 18 years old, who were diagnosed with NCCN low or intermediate risk prostate cancer and were managed with radical prostatectomy at the Urologic Oncology Branch, National Cancer Institute and collaborating centers
* Biopsy Gleason Score \<= 7
* Multiparametric MRI, with images available for review, within 6 months prior to the prostatectomy
* Availability of adequate diagnostic biopsy tissue specimen for GPS analysis

Design:

* This multisite study will be a prospective analysis of retrospective data.
* Samples and images will be obtained from will consist of approximately 277 evaluable patients who were diagnosed with NCCN low or intermediate risk prostate cancer and were managed with RP at the Urologic Oncology Branch, National Cancer Institute and collaborating centers.
* In the interest of a demographically diverse cohort, samples and images from patients from UAB will be identified, working in reverse chronological order until the cohort is complete or eligible specimens are exhausted; remaining cases will then be selected from the NCI patient population, also working in reverse chronological order.
* Tumor tissue from the highest-grade lesion will be tested with the Oncotype DX Genomic Prostate Scor for generation of the GPS.
* Clinical characteristics including but not limited to age at diagnosis, race, PSA, biopsy results, Prostate MRI PIRADS score, and surgical pathology results will be collected and merged with GPS results.

Integrated Genomic Prostate Score With MRI Targeted Prostate Biopsies

UAB-NCI Collaborative Study on Integrating Genomic Prostate Score With MRI Targeted Prostate Biopsies

To determine if there is a positive relationship between continuous GPS score and occult high-risk disease on whole mount prostatectomy specimens where an MRI was performed less than 6 months before diagnostic biopsy, and the biopsy was less than 6 months before RP and the lesion was not identified on mpMRI

To compare the distributions of clinical, pathological and demographic variables for the Genomic Health, Inc. (GHI) study cohort with all the eligible samples from patients in the participating institutions databases

Ultrasound ablation of focal prostate cancer

Transurethral MR-Thermometry Guided Ultrasound Ablation of the Prostate

TULSA-PRO

Jill M Harper, Ph.D.

Background:

The ability to treat early prostate cancer is still limited. Thermal ablation methods are being tested for focal prostate cancer therapy. Researchers want to improve on these methods.

Objective:

To understand if Transurethral UltraSound Ablation (TULSA) in combination with MRI guidance is useful to treat localized prostate cancer.

Eligibility:

English-speaking adults ages 18 and older with localized prostate cancer that can be seen on MRI and can be treated by thermal ablation.

Design:

Participants will be screened with the following:

* Medical history
* Physical exam
* Digital rectal exam
* Blood and urine tests
* Electrocardiogram
* Tumor biopsy
* Questionnaire to assess urinary tract symptoms
* MRI of the pelvis. The MRI scanner is a long, narrow tube. Participants will lie on a bed that moves in and out of the scanner.

Participants may also be screened with the following:

* Echocardiogram
* Chest x-ray
* Bone scan
* Urodynamic studies to see how well the bladder, sphincters, and urethra hold and release urine
* MRI of the brain
* Transrectal ultrasound
* Computer tomography (CT) scan of the chest, abdomen, and pelvis. A CT scan is a series of x-ray images taken of parts of the body.

Some screening tests will be repeated during the study.

Participants will have the TULSA procedure. They will have an MRI for guidance. A small ultrasound applicator will be placed into their urethra. It uses heat to destroy the cancer areas in the prostate. It is controlled by a robotic arm. A cooling catheter will be placed into their rectum.

Participants will use a urethral catheter for 1-7 days.

Participants will have follow-up visits at 3, 6, 12, 18, 24, and 36 months.

Background:

Prostate cancer is relatively slow growing, with doubling times for local tumors estimated at 2 to 4 years.

Some prostate cancers prove to be small, low grade, and noninvasive and they appear to pose little risk to the life or health of the host. Recent patient series suggest that 20% to 30% of men undergoing radical prostatectomy have pathologic features in the radical prostatectomy specimen consistent with an insignificant or "indolent" cancer which poses little threat to life or health.

We propose that participants with low volume and low grade disease can be best served with focal ablation of the visible prostate cancer without the side effects of urinary incontinence and erectile dysfunction associated with radiation therapy or radical surgery.

Focal Therapy for prostate cancer has gained popularity however prior studies demonstrate a failure rate as high as 50% with a laser.

Objective:

To determine the feasibility of magnetic resonance image (MRI)-guided ultrasound-induced thermal therapy of biopsy-confirmed and MRI visible, prostate tumor(s) using the TULSA Thermal Therapy System (Profound Medical)

Eligibility:

Subjects with prostate cancer, amenable for ultrasound ablation

Organ confined clinical T1c or clinical T2a prostate cancer, visible on MRI, and confirmed by prostate biopsy

Adequate organ and marrow function

Prostate-specific antigen (PSA) \< 20 ng/ml

Age \>=18 years

Design:

Study testing feasibility and tolerability of ultrasound ablation of focal prostate cancer.

It is anticipated that 15 participants will be accrued for this study.

Pilot Study to Investigate Magnetic Resonance (MR) Image Guided Focal Therapy in Prostate Cancer

Magnetic Resonance Image (MRI) Guided High Energy Ultrasound for Focal Prostate Cancer Ablation

.All IPD recorded in the medical record will be shared with intramural investigators upon request

To determine the feasibility of magnetic resonance image (MRI)-guided ultrasound-induced thermal therapy of biopsy-confirmed and MRI visible, prostate tumor(s) using the TULSA Thermal Therapy System (Profound Medical)

Address short- and long-term complication rates of study treatment by tabulating adverse events by grade according to CTCAE, and analyzing and reporting descriptively

Determine if focal ablation of MRI visible, biopsy-confirmed prostate cancer using the TULSA Thermal Therapy System (Profound Medical) platform can successfully ablate targeted prostate cancer lesions in \>50% of participants

Observe thermal damage on post-contrast MRI which extends into areas of the Rectum or Urethra; assess frequency of not completing the procedure

Use descriptive statistical analysis to examine serial PSA, PSA density, changes in imaging and biopsy, International Prostate Symptom Score (IPSS), and Sexual Health Inventory for Men (SHIM)

Single Arm Study, MRI and Prostate-Biopsy on same patient, individual patient acts as own control for intervention

First an advanced MRI prostate image is obtained, annotated and recorded by the Radiology of the Kantonsspital Winterthur. Next, using special fusion technology, the recorded MRI image is fused with a live transrectal ultrasound by the Urologist who performs a MRI/TRUS fusion biopsy.

MRI-TRUS fusion prostate biopsy

The investigators examined whether a high PI-RADS v2 score correlates with the presence of prostate cancer. In addition, the investigator inspected whether the lesion size as determined by mpMRI correlates with the presence of prostate cancer. Furthermore, the investigators study aimed to determine the sensitivity and specificity of mpMRI with respect to prostate carcinoma detection.

Purpose: In recent years, multiparametric Magnet Resonance Imaging (mpMRI) has been established as a diagnostic imaging technique of the prostate and its assessment standardized with the "prostate imaging - data and reporting system" (PI-RADS v2). The previously established Likert scale from 1 to 5 has been shown to reflect the increasing probability of a carcinoma. Suspicious MRI lesions can be biopsied in a targeted fashion using ultrasound navigation termed fusion biopsy. The investigators examined whether a high PI-RADS v2 score correlates with the presence of prostate cancer. In addition, the investigators inspected whether the lesion size as determined by mpMRI correlates with the presence of prostate cancer. Furthermore, the investigators study aimed to determine the sensitivity and specificity of mpMRI with respect to prostate carcinoma detection.

Materials and Methods: This prospective study includes 228 consecutive patients, which underwent a perineal MRI-TRUS-fused prostate biopsy (BiopSee®, MedCom Company) during the period of September 2015 to March 2017 at the cantonal hospital Winterthur due to a suspicious PSA value, a suspicious digital rectal examination or a known prostate cancer under active surveillance. 71 patients were excluded due to lack of PI-RADS v2 diagnosis and / or MRI performed at a different center. Targeted biopsies were performed specifically in the indicated MRI lesions and standardized over the rest of the prostate (system biopsy).

Accuracy of mpMRI and MRI-targeted, Ultrasound-navigated Prostate Fusion Biopsy in Detection of Prostate Cancer

Accuracy of Multi-parametric Prostate MRI and MRI-targeted, Ultrasound-navigated Prostate Fusion Biopsy in the Detection of Prostate Cancer:

Histological grade of the glandular structures of prostate cancer tissue or the difference in appearance compared with a normal structure.

Pattern 1 - corresponds to a well differentiated carcinoma. Pattern 2 - corresponds to a moderately differentiated carcinoma. Pattern 3 - invade the surrounding tissue or having an infiltrative pattern; corresponds to a moderately differentiated carcinoma.

Pattern 4 - corresponds to a poorly differentiated carcinoma. Pattern 5 - corresponds to an anaplastic carcinoma.

The pathologist then sums the pattern-number of the primary and secondary grades to obtain the final Gleason score.

Gleason scores range from 2 to 10, with 2 representing the most well-differentiated tumors and 10 the least-differentiated tumors.

New grading system for histological grade of the glandular structures of prostate cancer tissue or the difference in appearance compared with a normal structure

Grade Group 1 (Gleason score ≤6) - Only individual discrete well-formed glands Grade Group 2 (Gleason score 3+4=7) - Predominantly well-formed glands with a lesser component of poorly-formed/fused/cribriform glands Grade Group 3 (Gleason score 4+3=7) - Predominantly poorly-formed/fused/cribriform glands with a lesser component of well-formed glands Grade Group 4 (Gleason score 8)

* Only poorly-formed/fused/cribriform glands or
* Predominantly well-formed glands with a lesser component lacking glands or
* Predominantly lacking glands with a lesser component of well-formed glands Grade Group 5 (Gleason scores 9-10) - Lacks gland formation (or with necrosis) with or without poorly-formed/fused/cribriform glands

millilitre; size of suspected areas in prostate gland in MRI

Radiological grading system of prostate lesions in mpMRI

The PI-RADS v2 system is designed to standardize image acquisition and reporting, and to be used by medical professionals in the initial evaluation of patients to assess the risk of clinically significant prostate cancer that may require biopsy and treatment.

The scale is based on a score "Yes" or "No" for Dynamic Contrast-Enhanced (DCE) parameter, and from 1 to 5 for T2-weighted (T2W) and Diffusion-weighted imaging (DWI). The score is given for each lesion, with 1 being most probably benign and 5 being highly suspicious of malignancy:

PI-RADS 1: very low (clinically significant cancer is highly unlikely to be present) PI-RADS 2: low (clinically significant cancer is unlikely to be present) PI-RADS 3: intermediate (clinically significant cancer is equivocal) PI-RADS 4: high (clinically significant cancer is likely to be present) PI-RADS 5: very high (clinically significant cancer is highly likely to be present)

ng per ml; enzyme secreted by the prostate gland

ng per ml per ml; The relationship of the prostate specific antigen level to the size and weight (volume) of the prostate.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Multiparametric Magnetic Resonance Imaging of the Prostate to Assess Disease Progression and Genomics in Patients Undergoing Active Surveillance for Prostate Cancer	NCT04692675	Prostate Cancer	mpMRI	18 Years -	National Institutes of Health Clinical Center (CC)
Chemotherapy, Hormone Therapy, and Surgery to Remove the Prostate Gland in Patients With High Risk Prostate Cancer	NCT00108290	Prostate Cancer	Chemotherapy	18 Years - 80 Years	VA Office of Research and Development
Integrated Genomic Prostate Score With MRI Targeted Prostate Biopsies	NCT04541030	Prostate Cancer		18 Years -	National Institutes of Health Clinical Center (CC)
Pilot Study to Investigate Magnetic Resonance (MR) Image Guided Focal Therapy in Prostate Cancer	NCT04808427	Prostate Cancer	TULSA-PRO	18 Years -	National Institutes of Health Clinical Center (CC)
Multiparametric Magnetic Resonance Imaging of the Prostate to Assess Disease Progression and Genomics in Patients Undergoing Active Surveillance for Prostate Cancer	NCT04692675	Prostate Cancer	mpMRI	18 Years -	National Institutes of Health Clinical Center (CC)
Accuracy of mpMRI and MRI-targeted, Ultrasound-navigated Prostate Fusion Biopsy in Detection of Prostate Cancer	NCT03615131	Prostate Cancer	MRI-TRUS fusion...	18 Years -	Kantonsspital Winterthur KSW
Chemotherapy, Hormone Therapy, and Surgery to Remove the Prostate Gland in Patients With High Risk Prostate Cancer	NCT00108290	Prostate Cancer	Chemotherapy	18 Years - 80 Years	VA Office of Research and Development

Spots Global Cancer Trial Database for gleason score