Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Adenocarcinoma

Neoplasm Metastasis

Recurrence

Disease Progression

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Neoplastic Processes

Disease Attributes

Patient with a confirmed diagnosis of prostate cancer will be included before starting any treatment. Recruitment will be carried out by urologists from the urology departments of the CHU of Guadeloupe and the CHU of Rennes.

Extra blood collection for dosages Urine collection for the dosage of non-persistent pollutants, isolation of extracellular vesicles released in urine, analysis of the microbiome, metagenomics to obtain a complete description of the bacterial functions represented as well as other microorganisms present, metabolome profiling and identification and/or assays of any other biological compound of interest strictly related to the specific objectives of the research.

Saliva collection for the extraction of the constitutional DNA. An interview using a structured questionnaire A quality of live auto-questionnaire

Standard care

Valérie HAMONY-SOTER

Eunice NUBRET

Valérie Hamony Soter

Romain MATHIEU

Laurent BRUREAU

The course and progression of prostate cancer is highly variable, depending on the individual characteristics, the aggressiveness of the disease at the time of diagnosis as well as the ethno-geographic origins of the individuals. The general objective of the project is to identify the clinical, genetic and environmental determinants (risk factors) of the evolution, progression and complications of the disease according to the treatment options. Identifying modifiable and non-modifiable prognostic determinants of disease progression is a major challenge. This knowledge will help guide treatment choices but also, especially in high-risk populations (high incidence of disease) to better tailor prevention policies and possibly screening .

There is a lack of information to predict the course of prostate cancer following its initial diagnosis; in other words, why some are indolent and evolve very slowly and others are aggressive, evolve rapidly with an increased risk of metastasis development and death. In addition, these evolutions do not seem similar according to ethno-geographic origins. We therefore hypothesize that in addition to genetic susceptibility factors specific to individuals and / or linked to their ethno-geographic origins, medical, occupational and environmental factors can influence the course of the disease and the response to treatments. We will build two prospective cohorts of incident cases of prostate cancer, one in Guadeloupe (whose population is predominantly Afro-descendant) and one in Rennes (Brittany, whose population is mainly of Caucasian origin). Each patient will be subject to longitudinal follow-up over time. Structured questionnaires will be administered at the time of diagnosis and at regular times after the initial treatment or subsequent treatments. They will focus on socio-demographic data, places of residence, education levels, lifestyles (tobacco, alcohol), personal and family medical history, current treatments, current and past occupational activities. Anthropometric and blood pressure measurements will be made at the time of diagnosis and at regular times after treatment. Saliva, urine and blood samples will be obtained. Clinical data related to the disease will be collected continuously.

Any patient with a histologically confirmed incident case of prostate cancer will be included in the study

Clinical, Genetic and Environmental Determinants of Prostate Cancer Progression.

dependent variables: These are mainly criteria relating to :Discharge from active surveillance, Biological recurrence,Radiological, loco-regional or distant progression,

Independant variables. These are mainly criteria relating to :

Date of initial treatment and dates of successive treatments, Gleason score (ISUP) at diagnosis Gleason score (ISUP) on surgical specimen pTNM stage after surgery Body mass index \[kg/m²\], percentage of fat mass, % of water mass, % of bone mass estimated by bio-impedance.

Metabolic syndrome (3 of the following 5 criteria): triglycerides \> 1.7 mmo

Dependent variables Adverse events (disease-related or treatment-related) rated according to CTCAE grades (Common Terminology Criteria for Adverse Events) Micturition disorders estimated by the International Prostate Symptom Score (IPSS) Erectile function estimated by the IIEF5 score (International Index of Erectile Function) Quality of life estimated by the FACT-P score (Functional Assessment of Cancer Therapy-Prostate) Independent variables These are the same as those indicated for the primary endpoints.

Institut National de la Santé Et de la Recherche Médicale, France

Centre Hospitalier Universitaire de Pointe-a-Pitre

Rare Diseases

Carcinoma

Urinary Bladder Neoplasms

Carcinoma, Transitional Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urologic Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Transitional Cell Carcinoma

All Drugs and Chemicals

BCG Vaccine

Vaccines

Adjuvants, Immunologic

Immunologic Factors

* Bacillus Calmette-Guérin (BCG): Strain Russian BCG-I
* Freeze-dried powder for bladder instillation

* Standard of Care
* Bacillus Calmette-Guérin (BCG): Strain TICE
* Freeze-dried powder for bladder instillation

* Induction: 80 mg weekly for 6 weeks.
* Maintenance for intermediate AUA risk patients will be for 3 weeks at 3, 6, and 12 months.
* Maintenance for high AUA risk patients will be for 3 weeks at 3, 6, 12, 18, 24, 30 and 36 months.

Bacillus Calmette-Guerin: Strain Russian BCG-I

* Induction: 50 mg weekly for 6 weeks.
* Maintenance for intermediate AUA risk patients will be for 3 weeks at 3, 6, and 12 months.
* Maintenance for high AUA risk patients will be for 3 weeks at 3, 6, 12, 18, 24, 30 and 36 months.

Bacillus Calmette-Guerin: Strain TICE

Jalees Farhan

Taniya Mann

Alexandre R Zlotta, MD

Girish S Kulkarni, MD

The aim of this study is to evaluate the effect of Verity-BCG in patients with intermediate and high-risk non-muscle-invasive bladder cancer (NMIBC) and to compare our findings to the standard of care BCG formulation, OncoTICE (BCG) in order to examine our hypothesis that Verity-BCG is at least non-inferior to OncoTICE in achieving 24-month Recurrence Free Survival in NMIBC patients who are at high risk of recurrence and have never been treated with intradermal or intravesical BCG before, with the exception of tuberculosis vaccination in childhood.

This study is a randomized, active control, double-blind clinical trial aimed at demonstrating non - inferiority of VERITY-BCG to OncoTICE, the current standard of care, with respect to two-year Recurrence Free Survival (RFS) rates in NMIBC BCG - naïve patients that are at high risk for recurrence (defined as \>50%).

• Recurrence will be defined as the reappearance of any of the NMIBC tumors as confirmed by cystoscopic biopsy or TURBT.

Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients With Intermediate and High-risk Non-muscle Invasive Bladder (NMIBC)

A Multicenter, Randomized, Double-blind, Controlled Phase III Non-inferiority Study Assessing Efficacy and Safety of VERITY-BCG in Management of Intermediate and High-risk Non-muscle Invasive Bladder Cancer (NMIBC) in BCG-naïve Patients.

Incidence of treatment-emergent AEs and SAEs defined according to the CTCAE v5.0;

Number of subjects discontinuing study drug due to AEs

Usage of concomitant medications over time.

Cumulative Recurrence Free Survival (RFS) at 24 months following 1st intravesical instillation as estimated using the Kaplan - Meier estimator of the survival function.

Recurrence will be defined as the reappearance of any of the NMIBC tumors as confirmed by cystoscopic biopsy or TURBT.

Cumulative Recurrence Free Survival (RFS) at 36 months following 1st intravesical instillation as estimated using the Kaplan - Meier estimator of the survival function.

Progression Free Survival (PFS) at 24 months as estimated using the Kaplan - Meier estimator of the survival function.

Progression Free Survival (PFS) at 36 months as estimated using the Kaplan - Meier estimator of the survival function.

Overall Survival (OS) at 36 months as estimated using the Kaplan - Meier estimator of the survival function.

Change in Quality of Life as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire for NMIBC (EORTC-QLQ-NMIBC24) over 36 months.

The EORTC QLQ-NMIBC24 is a 24-item self-administered questionnaire that measures health-related quality of life in patients with intermediate to high-risk NMIBC. Items are ranked by the patient from 1 to 4 indicating the extent to which they have experienced those symptoms or problems. 1 = Not at All, 2 = A little, 3=Quite a bit, 4 = Very Much.

- High Score is equivalent to more problems, except for items on sexual function and sexual enjoyment for which a high score is interpreted as better function.

Change in functioning and symptom status as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire for Cancer Patients (EORTC-QLQ-C30) over 36 months.

The EORTC QLQ-C30 consists of 30 items and measures Health Related Quality of Life as well as presence of symptoms across all cancer types. The QLQ-C30 includes nine multi-item scales:

* 5 functional scales (physical, role, cognitive, emotional, and social)
* 3 symptom scales (fatigue, pain, and nausea and vomiting);
* A global health and quality-of-life scale\*
* Several single-item symptom measures

  28 Items are ranked 1 to 4. 1 = Not at All, 2 = A little, 3=Quite a bit, 4 = Very Much.

  \*2 items are ranked 1 to 7. 1=Very Poor, 7 = Excellent.

High score = More symptoms or worse problems

\*High Score = Better overall health or Quality of life.

Verity Pharmaceuticals Inc.

Herbal and Botanical

Astragalus

125 mg/day PG2 treatment continuously for 7 days

250 mg/day PG2 treatment continuously for 7 days

500 mg/day PG2 treatment continuously for 7 days

Woei-Yao Kao, Chief

The objectives of this Phase I/II study are:

1. To find out the maximum tolerated dose (MTD) of PG2 in patients with advanced malignancy receiving chemotherapy and to define a "Study Dose" for Phase II.
2. To evaluate the hematopoietic and immunological responses after administering of PG2. Primarily to study the biological response of PG2, defined as WBC count in this study, and secondarily to study the immunological factors, IL-2, IL-6, TGF-beta, and G-CSF.

This study is the first step for PG2 clinical development in Taiwan in order to further establish its safety and efficacy profile and to build the basis for larger trials.

PG2 Phase I/II Clinical Study Intravenously Administered in Patients With Advanced Malignancy

For phase I study, the primary endpoint is to determine a safe dosage of PG2 by the dose escalation design.

For phase II study, the primary endpoint is to compare the WBC level between PG2 plus chemotherapy and chemotherapy alone.

For phase II study, the secondary endpoint is to compare the levels of IL-2, IL-6, TGF-beta and G-CSF between PG2 plus chemotherapy and chemotherapy alone.

PhytoHealth Corporation

Bone Density Conservation Agents

Micronutrients

Vitamins

Vitamin D

Cholecalciferol

Vitamin D3

Calciferol

calcifidiol

Guy Howard, Ph.D

Gary Schwartz, Ph.D, MPH

James Schlesselman, Ph.D

Prostate cancer is a common occurrence in the aging population, with one in ten men destined to develop the disease. 40% of patients with prostate cancer experience a recurrence after definitive treatment. This study addresses the as-yet unresolved problem of the optimal management of early recurrence as manifested by increase in the accepted marker for this disease, PSA. Vitamin D, an agent with cell-differentiating properties, has been shown to inhibit angiogenesis and cause differentiation of prostate cancer cells in the laboratory and to affect PSA favorably in clinical studies of patients with advanced prostate cancer. This study will assess the effects of vitamin D in patients with sub-clinical biochemical relapses of prostate cancer as indicated by rising PSA but low tumor burdens, with the potential for developing an approach to this problem that will delay or prevent progression.

Calcifidol Therapy in Men With Cancer

US Department of Veterans Affairs

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Patients with a biopsy assessing an ipsilateral breast tumor recurrence, and a diagnosis of invasive carcinoma after a previous diagnosis of breast cancer that has been treated by breast conservative surgery at least one year before.

Before the SLNB procedure, each patient will have a lymphoscintigraphy to evaluate axillary and extra axillary lymphatic mapping.

Patients will be operated by breast conservative surgery (BCS) or mastectomy. Each patient will have a second SLND followed by a systematic complete ALND.

Sentinel Lymph-Node (LN) procedure and Axillary LN dissection ; Mastectomy or breast conservative surgery

Sentinel LN in breast cancer recurrence

VIRGINIE BORDES, MD

Sentinel lymph node biopsy (SLNB) has become the standard procedure for staging of patients with clinically node-negative breast cancer.

Breast-conserving surgery (BCS) has also been a standard treatment for patients with early breast cancer. However, approximately 10% of patients with BCS develop ipsilateral breast tumor recurrence (IBTR), and mastectomy or resection of the recurrent tumor is generally performed.

There are no specific guidelines available regarding staging and treatment of the regional lymph nodes. However, the reported risk of axillary lymph node metastasis among patients with local recurrence after breast surgery and a previous negative sentinel node biopsy of 26 % is too high to be ignored.

Moreover, evaluation of the regional lymph node basins might be helpful to decide on the indication for adjuvant radiotherapy and systemic treatment. For these reasons it seems sensible to perform a regional lymph node staging procedure in patients with locally recurrent breast cancer.

In general practice, this would mean that patients with recurrent breast cancer and a previous negative sentinel node biopsy would receive an axillary lymph node dissection (ALND) and that patients with a previous ALND would receive no additional axillary staging.

Lymphatic drainage after previous breast surgery and/or radiotherapy would be altered and it remains questionable whether SLNB at the time of surgery for IBTR (second SLNB) is technically feasible and ALND can safely be omitted.

In this study, investigators propose for all patients the realization of SLNB procedure and systematically ALND whatever the results of SLNB analysis, only on patients previously treated with breast conservative surgery.

The aim of this study is to evaluate on a homogeneous prospective multicentric cohort of patients the feasibility and the accuracy of a second SLNB procedure for IBTR.

FIGARO is a prospective multicentre phase-2 study that aims to evaluate technical feasibility and validity of performing second sentinel lymph node dissection (SLND) in patients with IBTR .

To be included, patients must have a biopsy assessing an ipsilateral breast tumor recurrence, and a diagnosis of invasive carcinoma after a previous diagnosis of breast cancer that has been treated by breast conservative surgery at least one year before (time between the end of the previous radiotherapy and the diagnosis of recurrence).

At time of recurrence, the patients must be evaluated by X-ray mammography and ultrasonography examination of breast and axilla, and a full general assessment to eliminate distant metastasis.

Local recurrences will be operated by breast conservative surgery (BCS) or mastectomy. The decision between BCS and mastectomy will be carefully considered, in accordance with patient preference and other clinical features such as tumor location, tumor size, and breast size taken into account.

Each patient will have a second SLNB followed by a systematic complete ALND. Before the SLNB procedure, each patient will have a lymphoscintigraphy to evaluate axillary and extra axillary lymphatic mapping. Lymphoscintigraphy will be performed according to previously reported standard techniques. At 2-20 h after lymphoscintigraphy, SLNB will be performed with or without a blue dye associated injection. An intraoperative gamma ray detection probe will be used during surgery to conﬁrm locations of the sentinel nodes and to facilitate their removal. All sentinel nodes will be removed and sent for histopathologic examination according to previously described standard techniques. A complete ALND (Berg's stage I and II) will be realized and the nodes will be sent for standard histopathologic examination.

Further systemic adjuvant therapies will be chosen in a multidisciplinary approach considering prognostic and predictive indicators.

All the patients will be followed up for 5 years at 12-month intervals after the second surgery and undergo annual mammography with or without ultrasonography.

Sentinel Lymph Node Procedure in Ipsilateral Invasive Breast Cancer Relapse

Feasibility and Accuracy of Lymph-node (LN) Restaging by Sentinel LN Procedure and Axillary LN Dissection in Ipsilateral Invasive Breast Cancer Relapse

Ratio of the number of cases with detection of negative sentinel axillary lymph node but with at least one metastatic lymph node in the axillary dissection on the total number of patients with at least one detected a sentinel axillary node and at least one metastatic lymph node, either in a sentinel axillary lymph node or in complete ALND

Ratio of the number of patients injected, technetium +/- blue, in which at least one sentinel axillary lymph node was detected intraoperative on the total number of patients injected

% of patient requiring consolidation radiotherapy on axillary and extra-axillary lymph node sites

Lymphoscintigraphy will be performed within 24 hours before surgery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical, Genetic and Environmental Determinants of Prostate Cancer Progression.	NCT06046131	Prostatic Neopl... Adenocarcinoma Neoplasm Recurr... Neoplasm Metast...	Standard care	18 Years -	Centre Hospitalier Universitaire de Pointe-a-Pitre
Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients With Intermediate and High-risk Non-muscle Invasive Bladder (NMIBC)	NCT05037279	Bladder Cancer Bladder Cancer ... Neoplasm Recurr... Urothelial Carc... Urothelial Carc... Non-Invasive Bl...	Bacillus Calmet... Bacillus Calmet...	18 Years -	Verity Pharmaceuticals Inc.
Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients With Intermediate and High-risk Non-muscle Invasive Bladder (NMIBC)	NCT05037279	Bladder Cancer Bladder Cancer ... Neoplasm Recurr... Urothelial Carc... Urothelial Carc... Non-Invasive Bl...	Bacillus Calmet... Bacillus Calmet...	18 Years -	Verity Pharmaceuticals Inc.
PG2 Phase I/II Clinical Study Intravenously Administered in Patients With Advanced Malignancy	NCT01696565	Neoplasm Metast... Neoplasm Recurr...	PG2	20 Years - 75 Years	PhytoHealth Corporation
Calcifidol Therapy in Men With Cancer	NCT00018538	Prostate Cancer	calcifidiol	-	VA Office of Research and Development
Calcifidol Therapy in Men With Cancer	NCT00018538	Prostate Cancer	calcifidiol	-	VA Office of Research and Development
Sentinel Lymph Node Procedure in Ipsilateral Invasive Breast Cancer Relapse	NCT03630653	Invasive Breast... Ipsilateral Rec... Sentinel Lymph ...	Sentinel LN in ...	18 Years -	Institut Cancerologie de l'Ouest
Calcifidol Therapy in Men With Cancer	NCT00018538	Prostate Cancer	calcifidiol	-	VA Office of Research and Development

Spots Global Cancer Trial Database for neoplasm recurrence