Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Prostatic Hyperplasia

Hyperplasia

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

In this group, internship are given the pathology outcome of each prostate biopsy regularly twice a month.

In this group, internship are not given the pathology outcome of each prostate biopsy.

Let the internship regularly compare DRE result and the pathology outcome of prostate biopsy of each patient.

Routine review of DRE results by attending doctors

Shuxiong Zeng, M.D., Ph.D

Xiong Qiao, M.D., Ph.D

Chuanliang Xu, M.D., Ph.D

Yinghao Sun, M.D., Ph.D

The investigators conduct this prospective study to investigate the learning curve of digital rectal examination (DRE) for prostate cancer among internship. The investigators want to know how many DRE are usually needed for internship to be performed in urological practice to obtain a stable DRE accuracy.

Digital rectal examination (DRE) is a basic physical examination in routine practice in Urology. The DRE is a very important daily practice for screen prostate cancer, and each internship in Urology is required to perform this for patients suspected of prostate cancer or benign prostate hyperplasia. However, how many DRE are usually needed for a internship to perform so as to obtain a stable accuracy in daily practice is currently unknown. The investigators thus conduct this prospective trial to investigate the learning curve of DRE among internship.

Learning Curve of Digital Rectal Examination for Prostate Cancer Among Internship

IPD will be shared after the results of the study has been published. Related information will be given if request by email is agreed by the principle investigator.

To examine the sensitivity and specificity of the DRE performed by internship to reference standard of prostate biopsy in a prospective longitudinal cohort of around 700 participants who will undergo prostate biopsy due to suspect of prostate cancer. The investigators will investigate the sensitivity and specificity of DRE by different internship monthly.

To examine the sensitivity and specificity of the DRE performed by internship (group 1 with routinely review of pathologic outcome of prostate biopsy twice a month, and group 2 internship who are not told the results of prostate biopsy) to standard reference of prostate biopsy.

To compare the sensitivity and specificity of DRE to fPSA/tPSA and MRI (not any patients are required to have MRI examination of prostate, this will be determined at the discretion of attending doctor) to reference standard of prostate biopsy.

Changhai Hospital

Attending doctor in the Department of urology

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Anus Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Anus Diseases

Rectal Diseases

Anal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Patients receive nivolumab while on study. Patients undergo sigmoidoscopy, colonoscopy or anoscopy, proctoscopy or digital rectal exam, x-ray, CT scan, MRI, biopsy and blood sample collection throughout the study.

Patients undergo observation while on study. Patients undergo sigmoidoscopy, colonoscopy or anoscopy, proctoscopy or digital rectal exam, x-ray, CT scan, MRI, biopsy and blood sample collection throughout the study.

Biopsy

Biospecimen Collection

Colonoscopy

Computed Tomography

Digital Rectal Examination

High Resolution Anoscopy

Magnetic Resonance Imaging

Patient Observation

Proctoscopy

Sigmoidoscopy

X-Ray Imaging

Lakshmi Rajdev

This phase III trial investigates how well nivolumab after combined modality therapy works in treating patients with high risk stage II-IIIB anal cancer. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

PRIMARY OBJECTIVE:

I. To evaluate whether therapy with nivolumab following combined modality therapy (CMT) improves disease-free survival (DFS) compared with observation in patients with high risk anal carcinoma.

SECONDARY OBJECTIVES:

I. To compare nivolumab following combined modality therapy (CMT) with observation in patients with high risk anal carcinoma with regard to:

Ia. Objective response rate (complete \[CR\] and partial \[PR\]), stable disease and progression.

Ib. Severe toxicity interval. Ic. Colostomy-free survival. Id. Overall survival. Ie. Toxicity.

OUTLINE: Patients who received standard CMT are randomized to 1 of 2 arms.

ARM A: Patients receive nivolumab intravenously (IV) while on study.

ARM B: Patients undergo observation while on study

Patients undergo sigmoidoscopy, colonoscopy or anoscopy, proctoscopy or digital rectal exam, x-ray, computed tomography (CT) scan, magnetic resonance imaging (MRI), biopsy and blood sample collection throughout the study.

Nivolumab After Combined Modality Therapy in Treating Patients With High Risk Stage II-IIIB Anal Cancer

A Randomized Phase III Study of Nivolumab After Combined Modality Therapy (CMT) in High Risk Anal Cancer

Will be defined as the occurrence of progression of local disease, distant metastases, second primary or death from the date of randomization.

Will be defined by complete and partial response.

The following late side effects are considered as severe: any anal/rectal damage (ulcer, fistula, or perforation), rectal stenosis that required colostomy, skin ulceration, and severe fibrosis. This parameter estimates the probability of being free of late side effects for patients under loco-regional control.

Will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.

Canadian Cancer Trials Group

National Cancer Institute (NCI)

Central Nervous System Depressants

Adjuvants, Anesthesia

Analgesics

Psychotropic Drugs

Anti-Infective Agents

Anesthetics

Fentanyl

Midazolam

Propofol

Prilocaine

Fluconazole

Saturation biopsy was performed in left lateral decubitus position after application of sedo-analgesia by the anesthesiologists on an outpatient basis. After preparation of the rectal ultrasound probe and assuming an appropriate position, ultrasonographic examination of the prostate was performed on axial and sagittal plane. After injecting 3 cc of prilocaine to each of the right and left lobes in the right and left periprostatic region, prostatic size was measured and changes in the zonal anatomy and ultrasonographic view of the tissue were defined. Next, biopsy procedure was performed with an 18 G, 20 cm tru-cut biopsy needle and an automatic biopsy gun. After passing beyond the rectal mucosa, the needle was advanced until 0.5 cm proximal to the area of interest by tracking the image of the needle on the screen. As a total,24,26 or 28 biopsies were taken depending on prostate volume.

10-12 core biopsy was performed in left lateral decubitus position without sedo-analgesia on an outpatient basis. After preparation of the probe and assuming an appropriate position, ultrasonographic examination of the prostate was performed on axial and sagittal plane. After injecting 3 cc of prilocaine to each of the right and left lobes in the right and left periprostatic region, prostatic size was measured and changes in the zonal anatomy and ultrasonographic view of the tissue were defined. Next, biopsy procedure was performed with an 18 G, 20 cm tru-cut biopsy needle and an automatic biopsy gun. As a total 10 or 12 core biopsies were taken depending on prostate volume. The biopsies were taken form right base, right mid, right apex, right far-lateral base, right far-lateral mid and left base, left apex, left far-lateral base, and left far-lateral mid in 10 core biopsy, also two additional transitional zone biopsies were taken in 12 core biopsies.

Transrectal prostate biopsy was performed in left lateral decubitus position with sedo-analgesia in saturation biopsy group and without sedoanalgesia in 10-12 core biopsy group on outpatient basis. After preparation of the rectal ultrasound probe and assuming an appropriate position, ultrasonographic examination of the prostate was performed on axial and sagittal plane. Periprostatic block was performed with the injection of 3 cc of prilocaine to each of the right and left lobes in the right and left periprostatic region in both groups before biopsy. Biopsy procedure was performed with an 18 G, 20 cm tru-cut biopsy needle and an automatic biopsy gun. After passing beyond the rectal mucosa, the needle was advanced until 0.5 cm proximal to the area of interest by tracking the image of the needle on the screen.

Transrectal prostate biopsy with ultrasonography.

Periprostatic block was used for local anesthesia. 3 cc 2% prilocaine was injected to both periprostatic region in both saturation biopsy and 10-12 core biopsy group with transrectal ultrasonography.

Periprostatic block

Sedoanalgesia was used in saturation biopsy group. It was given by an anesthesiologist. Patients were given adequate counselling regarding sedoanesthesia as well as the biopsy procedure. They were advised to fast the night before the procedure.Before induction of sedoanalgesia all patients were monitorized for peripheric oxygen saturation and electrocardiography (ECG).Additionally nasal oxygen with 3ml/min was given to all patients by nasal canula.Sedoanalgesia was induced with 0.05mg/kg of midazolam, 1mg/kg of propofol and 1mg/kg of fentanyl. additional propofol was given with dose of 0.3mg/kg as patients needed.

Sedoanalgesia

Abdullah Demirtas, Assistant Prof., MD

Akın Avcı, Resident in UrologyMD,

Ibrahim Gulmez, Professor in Urology,M.D.

OBJECTIVE To assessment the results of repeated saturation and 10-12 core biopsy protocols in patients with a negative initial biopsy but continued suspicion for prostate cancer MATERIALS AND METHOD Data of the patients who underwent prostate biopsy between June 2007 and June 2012 were retrospectively assessed. Patients with an abnormal digital examination findings and/or abnormal serum prostate specific antigen levels were biopsied. The indication for a repeated biopsy was determined as the continued suspicion for a malignancy after the initial benign biopsy result and/or a pathology result consistent with a high-grade prostatic intraepithelial neoplasia or atypical small acinar proliferation. Patients who underwent saturation and core 10-12 biopsies at repeated biopsies were compared. Statistical analyses were performed with Shapiro-Wilk test and Mann- Whitney U test. A p value less than 0.05 was accepted as statistically significant.

Comparison Of Effectiveness of Transrectal Ultrasonography-Guided Saturation Biopsy And 10-12 Core Biopsy In Repeated Prostate Biopsies

Prostate cancer detection rate after saturation and repeated 10-12 core prostate biopsy.

TC Erciyes University

Assistant Professor

Participants over the age of 40 complete an educational intervention comprising a 10-20 minute PowerPoint presentation given by an experienced healthcare professional that discusses prostate cancer facts, screening guidelines, risks, benefits, and consequences. Participants may undergo a screening exam comprising a prostate specific antigen level and digital rectal exam.

Participants between 18 and 39 complete an educational intervention comprising a 10-20 minute PowerPoint presentation given by an experienced healthcare professional that discusses prostate cancer facts, screening guidelines, risks, benefits, and consequences.

Attend 10-20 minute PowerPoint presentation that will discuss prostate cancer facts, screening guidelines, risks, benefits, and consequences

Educational Intervention

Undergo digital rectal exam by a licensed healthcare professional. The results of this exam will be subjective as per clinician; however, will be coded as normal or abnormal. This is considered standard of care for prostate cancer screening

digital rectal examination

15 questions which test participants' knowledge of prostate cancer according to ACS guidelines. Questions will be multiple choices and true/false/unsure answers

Pre-test administration

Survey will be administered at the end of the program for participants to assess their experience

Survey Administration

PSA levels will be drawn and run as per institutional Laboratory standards. Criteria for referral and follow up will be assessed as per National Comprehensive Cancer Network (NCCN) guidelines

Prostate-specific antigen measurement

Post test will include the same 15 questions as on the pretest to assess for improvement in knowledge and understanding

Post test administration

Samir Abraksia, MD

This clinical trial studies an informed decision making intervention of screening for prostate cancer in predominantly African American participants. It also evaluates participants' knowledge about prostate cancer screening and to improve understanding. Using decision aids such as culturally sensitive written material, verbal information, and videos to educate patients about screening may increase patient participation and knowledge. This may increase confidence in participants' decisions. Raising awareness about prostate cancer in the communities may increase the participants' willingness to be screened for prostate cancer once they have learned about it.

PRIMARY OBJECTIVES:

(A) To assess the effectiveness of a proposed educational model for informed decision about Prostate Cancer in high risk men over age 40 which compares informed decision making and shared decision making (B) to improve knowledge about prostate cancer in men over age 18

OUTLINE:

Participants complete an educational intervention comprising a 10-20 minute PowerPoint presentation given by an experienced healthcare professional that discusses prostate cancer facts, screening guidelines, risks, benefits, and consequences. Some participants then undergo a screening exam comprising a prostate specific antigen level and digital rectal exam.

After completion of study, participants are followed up periodically.

Informed Decision Making Intervention in Screening for Prostate Cancer of Predominantly African American Participants in a Community Outreach Program

The Effectiveness of a Proposed Prostate Cancer Outreach Program in a Predominantly African American Community That Promotes Informed Decision-making for Prostate Cancer Screening and Utilizes Community Navigation

Improved understanding will be defined as an increase in the number of correct answers seen on the post Prostate Screening Education Questionnaire. The underlying likelihood of a positive response, or improved understanding of prostate cancer screening, can be estimated using a 95% confidence interval that has a maximum half-width of 6%.

Helpfulness of the program will be measured on a 5-point Likert scale where the two uppermost categories are considered a positive response.

Case Comprehensive Cancer Center

Patients undergo MRI-guided TULSA. Patients may also undergo DRE, cystoscopy, biopsy, bone scan, PSMA PET, and/or mpMRI at screening.

MRI-Guided Transurethral Ultrasound Ablation

Quality-of-Life Assessment

Questionnaire Administration

Cystoscopy

Bone Scan

PSMA PET Scan

Multiparametric Magnetic Resonance Imaging

Clinical Trial Referral Office

David A. Woodrum, M.D., Ph.D.

David A Woodrum, M.D., Ph.D.

This clinical trial tests whether the magnetic resonance imaging (MRI)-guided transurethral ultrasound ablation (TULSA) procedure is safe and effective in treating patients with intermediate grade prostate cancer. MRI-guided TULSA ablation is a minimally invasive procedure that uses an ultrasound device guided by MRI imaging to deliver high-energy sound waves, producing very high temperature to ablate (destroy) tumor cells in a targeted manner. The MRI-guided TULSA procedure may help patients avoid surgery and help improve prostate cancer patients' quality of life.

PRIMARY OBJECTIVE:

I. To perform the TULSA procedure for safety and efficacy outcomes in men aged 45 to 80 years with biopsy-confirmed, National Comprehensive Cancer Network (NCCN) intermediate-risk prostate cancer.

SECONDARY OBJECTIVE:

I. To assess patient-reported metrics for quality of life (QOL). II. To assess return to normal activity. III. Compare economic benefit as noted from Expanded Prostate Cancer Index Composite (EPIC) questionnaire.

OUTLINE:

Patients undergo MRI-guided TULSA. Patients may also undergo digital rectal exam (DRE), cystoscopy, biopsy, bone scan, prostate specific membrane antigen (PSMA) positron emission tomography (PET), and/or multiparametric MRI (mpMRI) at screening.

After completion of study treatment, patients are followed at 3, 6, 9, 12, 15, 18, 21 and 24 months.

MRI-guided Transurethral Urethral Ultrasound Ablation for the Treatment of Intermediate Grade Prostate Cancer

Focal Prostate Ablation for Intermediate Grade Cancer Utilizing TULSA Profound System

Failure is defined as: delivery of any additional intervention for prostate cancer (local or systemic, including adjuvant therapy); or metastatic disease; or prostate cancer-specific death.

Continence is defined as 'pad-free' (0 pads/day), and potency is defined as erection firmness sufficient for penetration (Expanded Prostate Cancer Index Composite \[EPIC\]). Two-sided, 95% Pearson-Clopper confidence interval (CI) will be calculated for each intervention arm separately, and the difference in safety outcomes, along with exact 95% two-sided CI will be calculated.

In the absence of a validated threshold for biochemical failure in the setting of ablative therapies, the Phoenix criteria will be adopted for the transurethral ultrasound ablation (TULSA) procedure (nadir + 2 ng/mL). Prostate-specific antigen (PSA) is measured at baseline/procedure, 3, 6, 9, 12, 15, 18, 21, and 24 months. It's measured using Scale Grade Group 1, 2, 3, and 4.

The proportion of patients with clinically significant disease on targeted +/- systematic biopsy at 12 months. Clinically significant disease is defined as Gleason grade group 2 or higher. It is measured using scale Grade Group 1, 2, 3, and 4.

These data will also be collected at 24 months post-initial treatment, for patients who receive repeat TULSA procedure. Findings from for-cause mpMRI will also be captured using Pi-Rads 1-5, 1 being most likely not cancer to 5 being very suspicious.

These data will also be collected at 24 months post-initial treatment, for patients who receive repeat TULSA procedure. Findings from for-cause mpMRI will also be captured.

Will be estimated using the Kaplan-Meier method.

Change from baseline in the EPIC questions 1-7 domains and in the visual analog score will be measured at baseline, 6, 12, 18, and 24 months using Scale Grade Group 1, 2, 3, and 4.

Change from baseline in the EPIC questions 8-21 will be measured using Scale Grade Group 1, 2, 3, and 4.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Learning Curve of Digital Rectal Examination for Prostate Cancer Among Internship	NCT03479359	Prostatic Neopl... Digital Rectal ... Benign Prostati...	Routine review ...	-	Changhai Hospital
Nivolumab After Combined Modality Therapy in Treating Patients With High Risk Stage II-IIIB Anal Cancer	NCT03233711	Anal Basaloid S... Anal Canal Cloa... Anal Margin Squ... Stage IIB Anal ... Stage III Anal ...	Biopsy Biospecimen Col... Colonoscopy Computed Tomogr... Digital Rectal ... High Resolution... Magnetic Resona... Nivolumab Patient Observa... Proctoscopy Sigmoidoscopy X-Ray Imaging	18 Years -	National Cancer Institute (NCI)
Comparison Of Effectiveness of Transrectal Ultrasonography-Guided Saturation Biopsy And 10-12 Core Biopsy In Repeated Prostate Biopsies	NCT01827813	Prostate Cancer	Transrectal pro... Periprostatic b... Sedoanalgesia	40 Years - 70 Years	TC Erciyes University
Informed Decision Making Intervention in Screening for Prostate Cancer of Predominantly African American Participants in a Community Outreach Program	NCT02419846	Prostate Carcin...	Educational Int... digital rectal ... Pre-test admini... Survey Administ... Prostate-specif... Post test admin...	19 Years -	Case Comprehensive Cancer Center
Comparison Of Effectiveness of Transrectal Ultrasonography-Guided Saturation Biopsy And 10-12 Core Biopsy In Repeated Prostate Biopsies	NCT01827813	Prostate Cancer	Transrectal pro... Periprostatic b... Sedoanalgesia	40 Years - 70 Years	TC Erciyes University
MRI-guided Transurethral Urethral Ultrasound Ablation for the Treatment of Intermediate Grade Prostate Cancer	NCT05438563	Prostate Carcin... Stage I Prostat... Stage II Prosta...	MRI-Guided Tran... Quality-of-Life... Questionnaire A... Digital Rectal ... Cystoscopy Biopsy Bone Scan PSMA PET Scan Multiparametric...	45 Years - 80 Years	Mayo Clinic

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