Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Androgens

(Open, laparoscopic or robot-assisted ) cystoprostatectomy with urinary diversion surgery and extended pelvic lymph node dissection; without adjuvant androgen deprivation therapy;

Radiotherapy by external beam radiotherapy (81 Gy，2.4-4 Gy per fraction over 4-6 weeks); with adjuvant androgen deprivation therapy for the least 3 years

Patients with bladder infiltrating T4 prostate cancer receive cystoprostatectomy with urinary diversion surgery and extended pelvic lymph node dissection

Cystoprostatectomy

Patients with bladder infiltrating T4 prostate cancer are treated with adjuvant androgen deprivation therapy

external beam radiotherapy

Zhiqiang Chen, M.D.,Ph.D

Peng Yuan, M.D.

Prostate cancer is the most common male cancer in global, which accounts for 19% of the total and poses great hazards to male health. Unfavorable factors including prostatic specific antigen (PSA) \>20 ng/ml, Gleason score \>8, and T3/4 are significantly associated with biological recurrence, metastatic progression and poor survival in prostate cancer. In clinical T4(cT4) prostate cancer with bladder invasion patients, symptoms of hematuria, urinary urgency, bladder outlet and ureteral obstruction, and pelvic pain led to a poor quality of life.

Radical prostatectomy is crucial for the multimodal treatment of prostate cancer, but limited proof demonstrated enough advantages of the surgery in T4 tumor with bladder invasion. Radical prostatectomy could hardly meet both demands of local tumor control and urinary function. Treatment trends suggest that patients with T4 prostate cancer be treated with radiotherapy combined with androgen deprivation therapy (ADT). However, surgery enables a full pathological assessment of the tumor characteristics and thus a better estimation of the risk of recurrence. Cystoprostatectomy offers an option of surgical treatment for T4 prostate cancer with bladder invasion，which can well remove the bladder and urethra, decrease the risk of positive surgical margins and avoid urination complications.

There is no consensus regarding optimal treatment of T4 prostate cancer and no evidence of oncological outcomes of cystoprostatectomy from clinical trials. A randomized clinical trial comparing two multimodal treatment regimens of cystoprostatectomy and radiotherapy for T4 prostate cancer with bladder invasion is therefore warranted.

1. Determine the subjects

Patients were determined in strict accordance with the inclusion and exclusion criteria, and the trial process and significance were explained to the patients, and informed consent was signed.

2 Randomization

The patients were randomly assigned to surgery group or radiotherapy group according to the random number table.

3 Implementation Process

The intervention measures were divided into operation group and non-operation group. The operation group was given cystoprostatectomy + expanded pelvic lymph node dissection + urinary diversion. The non-operation group received radiotherapy plus androgen deprivation therapy.

4 Follow-up Process

Follow-up was performed once a month (12 times in total) in the first year after surgery or radiotherapy, once every 3 months (4 times in total) in the second year, and once every six months after 2 years. Follow-up items included the presence of complications, digital rectal examination, PSA and testosterone levels, liver and kidney function. If digital rectal examination is positive and serum PSA continues to rise, pelvic MRI and bone scan should be performed. Bone pain, regardless of PSA level, should be scanned.

FunctionalAssessment of Cancer Therapy-General (FACT-G; FunctionalAssessment of Cancer Therapy-Prostate, FACT-P) and color Doppler ultrasonography of bilateral kidney and ureter were performed once every six months after 1 year.

Pelvic MRI, bone scan, chest radiograph, and color ultrasound of abdomen (liver, bile, pancreas and spleen) were examined once a year after surgery or radiotherapy.

Other follow-up examination items or follow-up time can be selected according to special circumstances. The patients were followed up for at least 10 years after surgery or after the end of radiotherapy.

5. Monitoring and management of recurrence, metastasis and complications

If biochemical recurrence after surgery (PSA level two consecutive acuity 0.2 ng/ml, two test interval of 2 weeks) or local recurrence, choose save radiotherapy, 8 Gy single, range is the whole pelvic, continued progress or control again after recurrence after radiotherapy are endocrine therapy, and its solution for than carew amine (50 mg 1 time, 1 times a day, Orally) + Goserelin (3.6mg once every 28 days, subcutaneously injected into the anterior abdominal wall); Patients with extensive metastasis after surgery were treated directly with endocrine therapy (bicalutamide 50mg once daily, orally) plus gosererin (3.6mg once every 28 days, subcutaneously injected into the anterior abdominal wall). The remaining tumor progression was managed according to the recommendations of authoritative guidelines at home and abroad.

The time of occurrence, name of complication, patient status, Clavien-Dindo complication classification, treatment measures and procedures, and treatment results were recorded. Complications were managed according to the recommendations of the guidelines and the experience of our unit.

Cystoprostatectomy Versus Radiotherapy Combined With ADT for the Treatment of cT4 Prostate Cancer With Bladder Invasion

Cystoprostatectomy Versus Radiotherapy Combined With Androgen Deprivation Therapy for the Treatment of Clinical T4 Prostate Cancer With Bladder Invasion: a Multicentre, Prospective, Open, Randomized Clinical Trial

The percentage of subjects in a study who have survived at the the endpoint of the observation since randomization or the interval between randomization and death from any cause.

the interval between randomization and biochemical recurrence or death from any cause or the percentage of subjects in a study who have survived without biochemical recurrence at the endpoint of the observation since randomization

the interval between randomization and tumor recurrence, metastasis, or death from any cause, or the percentage of subjects in a study who have survived without tumor recurrence or metastasis at the endpoint of the observation since randomization

This is a score system assessing cancer patients' quality of life, including four aspects of physical status, social status, emotional status and functional status. The total score ranges from 0-108 and a higher score indicates a better outcome.

This is a score system assessing prostate cancer patients' quality of life. The total score ranges from 0-48 and a higher score indicates a better outcome

Chinese PLA General Hospital

Xiangya Hospital of Central South University

Hubei Cancer Hospital

Tongji Hospital

Urinary Bladder Neoplasms

Urologic Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Yann NEUZILLET, PhD

In the investigators's previous work, measurements of intra-prostatic concentrations of sex steroids were determined on samples taken from the operating room using a punch.

In order to study the in-vivo intra-prostatic concentrations of sex steroid, it is necessary to validate a measurement technique performed on samples obtained by a biopsy needle used in standard care for prostate biopsy punctures allowing the diagnosis and follow-up of prostate cancer.

The aim of this project is to validate this measurement technique carried out on samples obtained by the biopsy needle and to define the optimal number of carrots obtained by biopsy offering dosage results comparable to the punch.

1 sample of prostate tissue obtained by punch (90 mg) 6 samples of prostate tissue obtained by biopsy needle (3 mg by sample)

Measurements of Sexual Steroids' Concentrations in Prostatic Tissue

Measurements of Sexual Steroids' Concentrations in Prostatic Tissue From Samples Taken by Biopsy Needle on Fresh Operating Parts : Measurements' Reliability

To compare intra-prostatic concentrations of sex steroids on samples taken by punch (reference technique) and by an increasing number (1 to 3 carrots) of samples taken by biopsy needle (experimental technique) on fresh surgical specimen.

Hopital Foch

mpMRI in the detection of prostate cancer in a per patient analysis using cystoprostatectomy specimen

mpMRI

Dominique GENRE, MD

Margot BERLINE, MSc, MBA

Dominique Genre, MD

Marc COLOMBEL, Pr

David Chemouni, MD

Aude Fregeville, MD

Nicolas MOTTET-AUSELO, Dr

Jochen WALZ, MD

To evaluate the negative predictive value of mpMRI in the detection of prostate cancer using cystoprostatectomy specimen as the reference

Per patient analysis in a prospective, multicenter cohort, open study.

male patient scheduled for cystoprostatectomy as treatment of muscle invasive bladder cancer

Multicentric Evaluation of the True Negative Predictive Value of Multiparametric MRI for the Detection of Prostate Cancer Using Cystoprostatectomy Specimen as Reference

The true negative and false negative rates of mpMRI in the detection of prostate cancer in a per patient analysis using cystoprostatectomy specimen as a reference in patients with no previous diagnosis of prostate cancer.

Institut Paoli-Calmettes

Symptoms and General Pathology

Behaviors and Mental Disorders

Shock

Erectile Dysfunction

Vasodilator Agents

Urological Agents

Anticoagulants

Other Dietary Supplements

Sildenafil Citrate

Phosphodiesterase 5 Inhibitors

Citric Acid

Sodium Citrate

Phosphodiesterase Inhibitors

Enzyme Inhibitors

Citrate

Intervention include that patients will undergo penile low-intensity extracorporeal shock wave therapy, 6-12 sessions, 1500 shocks per session, two sesssions per week for 3 weeks then 3 weeks break and then 2 sessions per week for 3 weeks.

Intervention include that patients will intke oral tablets of PDE-5 inhibitors :

- Oral intake of 50 mg once daily for 6 months.

Patients will be only followed up without any therapy for assisting erection.

The patients in this arm will be subjected to Penile LI-SWT in the following parameters: 6 to 12 sessions with 1500 shocks per session. Each session will comprise the application of 300 shock waves (energy intensity of 0.09 mJ/mm2) to each of five different sites on the penis: three along the penile shaft and two at the crura with Frequency: 4 HZ. Energy level: 8 mJ/mm2. Rate: 120 shocks per minute.

-Intervals: 2 treatment sessions per week for 3 weeks, then 3-weeks no-treatment interval, then 3-weeks treatment period of 2 treatment sessions per week.

LI-ESWT group

The patient in this arm will receive 50 mg of phosphodiesterase-5 inhibitors, oral intake once daily for 6 monthes.

PDE-5 inhibitors group

Tamer S. Zewin, MS

Ahmed M. Hazrra, MD

Tamer E. Zewin, Fellow

Ahmed M. Harraz, MD

Ahmed M. Asmy, MD

The aim of this clinical trial is to evaluate the role of extracorporeal low-intensity shock wave therapy in penile rehabilitation post nerve sparing radical cysto-prostatectomy.

60 patients for whom nerve sparing radical cystoprostatectomy will be carrried out, penile rehabilitation by using low intensity extracorporeal shock wave therapy will be applied in 20 patients, another 20 patients will receive oral phosphodiestrase type 5 inhibitorrs and 20 patients will not receive any interventions in the control group.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cystoprostatectomy Versus Radiotherapy Combined With ADT for the Treatment of cT4 Prostate Cancer With Bladder Invasion	NCT03482089	Prostate Cancer	Cystoprostatect... external beam r...	18 Years - 75 Years	Tongji Hospital
Measurements of Sexual Steroids' Concentrations in Prostatic Tissue	NCT04256161	Bladder Cancer		18 Years -	Hopital Foch
Cystoprostatectomy Versus Radiotherapy Combined With ADT for the Treatment of cT4 Prostate Cancer With Bladder Invasion	NCT03482089	Prostate Cancer	Cystoprostatect... external beam r...	18 Years - 75 Years	Tongji Hospital
Multicentric Evaluation of the True Negative Predictive Value of Multiparametric MRI for the Detection of Prostate Cancer Using Cystoprostatectomy Specimen as Reference	NCT03960112	Prostate Cancer	mpMRI	18 Years -	Institut Paoli-Calmettes
Role of Low-intensity Shock Wave Therapy in Penile Rehabilitation Post Nerve Sparing Radical Cysto-prostatectomy	NCT02422277	Bladder Cancer	LI-ESWT group PDE-5 inhibitor...	30 Years - 75 Years	Mansoura University

Spots Global Cancer Trial Database for cystoprostatectomy