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Prostatic Neoplasms

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Lower Urinary Tract Symptoms

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Genital Diseases, Male

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Androgens

These patient will be treated by TUPKRP and MAB.

These patient will be treated by MAB only.

TUPKRP is abbreviation of transurethral plasma kinetic resection of prostate, which is an effective treatment of bladder outlet obstruction for benign prostate hyperplasia. MAB is abbreviation of Maximal androgen blockade, which is a kind of endocrinotherapy for advanced prostate cancer.

Surgery combinate with Endocrine therapy

MAB is abbreviation of Maximal androgen blockade, which is a kind of endocrine therapy for advanced prostate cancer.

Endocrine therapy

Leye He, MD

Zhi Long, MD

Zhijun Huang, MD

Prostate cancer (PCa) is the second most frequently diagnosed cancer in men worldwide, accounting for 15% of all male cancers. In 2015, there were 220,800 estimated new cases of prostate cancer and 27,540 deaths by PCa, making this disease the second leading cause of cancer-related death for North American men.

Men with PCa may develop lower urinary tract symptoms (LUTS) when prostate tumors invade or compress the prostatic urethra, the bladder or the neurovascular bundles, or when the prostate is enlarged. It has been estimated that over 40% of men with PCa experience moderate or severe LUTS. LUTS can impact profoundly on a man's quality of life (QoL); an effect that increases with increasing LUTS severity.

Transurethral resection of prostate (TURP) can offer immediate relief of the obstruction in patients with benign prostatic hyperplasia (BPH). In contrast, palliative TURP (p-TURP) (the so-called "channel" TURP), is transurethral resection of prostate tissue in a patient with metastatic or locally advanced and/or previously treated PCa to alleviate obstructive voiding symptoms.

Al¬though TURP is commonly performed to relieve bladder outlet ob¬struction (BOO) symptoms in patients with BPH, little known about the outcome of palliative transurethral plasma kinetic resection of prostate (p-TUPKRP) in patients with ad-vanced PCa.

Gonadotropin-releasing hormone (GnRH) agonists as androgen deprivation therapy (ADT) are the standard treatment for many patients with PCa, particularly those with advanced or metastatic disease. The impact of ADT on tumor control and achieving the reduction in prostate specific antigen (PSA) is well established. But there is less information available on the effects on LUTSs in men with PCa. Some short-term studies of ADT with the GnRH antagonist or with ADT in the neoadjuvant setting have demonstrated reductions in LUTSs, measured by the International Prostate Symptom Score (IPSS). There are few published data on the longer-term effects of ADT on LUTSs, apart from an earlier interim analysis of data from the current study.

In this study, p-TUPKRP combined with ADT will perform for 50 patients with advanced PCa complicated with severe LUTS. As a control, other 50 advanced PCa patients with same symptoms will be treated with ADT only. Some clinical data, including PSA, IPSS, QoL, Urinary flow rate (UFR), ECOG Score, Overall survival (OS), progression-free survival (PFS), will be analyzed. It is expected to explore the efficacy and safety of the combination therapy to advanced PCa with severe LUTS.

TUPKRP Combined With MAB Therapy for LUTS/PCa

A Prospective, Multi-center Clinical Study of Palliative Transurethral Plasma Kinetic Resection of Prostate (TUPKRP) Combined With Endocrine Therapy for Advanced Prostate Cancer Complicated With Severe Lower Urinary Tract Symptoms

Prostate specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are usually reported as nanograms of PSA per milliliter (ng/mL) of blood. The blood level of PSA is often elevated in men with prostate cancer. PSA will be used to evaluate the effectiveness of tumor therapy

Uronary flow rate is the volumetric flow rate of urine during urination. It is a measure of the quantity of urine excreted in a specified period of time (per second or per minute). It is measured with uroflowmetry, a type of flowmetry. The "Q" (a conventional symbol for flow rate) is used as a symbol for urine flow rate. Qmax indicates the maximum flow rate. Qmax is used as an indicator for the diagnosis of enlarged prostate. A lower Qmax may indicate that the enlarged prostate puts pressure on the urethra,

International prostate symptom score(IPSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35. The first seven questions of the I-PSS are identical to the questions appearing on the American Urological Association (AUA) Symptom Index which currently categorizes symptoms as follows: Mild (symptom score less than of equal to 7); Moderate (symptom score range 8-19); Severe (symptom score range 20-35).

Quality of life due to urinary symptoms is base on the question, If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? The International Scientific Committee (SCI), under the patronage of the World Health Organization (WHO) and the International Union Against Cancer (UICC), recommends the use of only a single question to assess the quality of life. The answers to this question range from "delighted" to "terrible" or 0 to 6. Although this single question may or may not capture the global impact of benign prostatic hyperplasia (BPH) Symptoms or quality of life, it may serve as a valuable starting point for a doctor-patient conversation.

Physical status scores of East Cancer cooperative Group. Grade 0:Fully active, able to carry on all pre-disease performance without restriction; Grade 1:Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; Grade 2:Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours; Grade 3:Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours; Grade 4: Completely disabled; cannot carry on any selfcare; totally confined to bed or chair; Grade 5: dead.

Magnetic Resonance Imaging (MRI) of the prostate uses a powerful magnetic field, radio waves and a computer to produce detailed pictures of the structures within a man's prostate gland. It is primarily used to evaluate the extent of prostate cancer and determine whether it has spread. MRI of the prostate can be used to determine the efficacy of therapy and imaging progression-free survival.

In prostate cancer, bone is the second most common site of metastatic disease after lymph nodes. Single-Photon Emission Computed Tomography (SPECT) in imaging bone metastases is increasing in popularity for staging newly diagnosed prostate cancer and for assessing response to therapy. SPECT can be used to determine the efficacy of therapy and imaging progression-free survival.

PVR is post void residual urine volume. In those who can void, incomplete bladder emptying is diagnosed by postvoid catheterization or ultrasonography showing an elevated residual urine volume. A volume \< 50 mL is normal.

Overall survival, or OS, the length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.

Progression-free survival (PFS) is "the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse"

The Third Xiangya Hospital of Central South University

Recurrence

Nootropic Agents

Gastrointestinal Agents

Lipid Regulating Agents

Vitamins

Choline

Comparing the detection rate of metastases of whole body MRI compared to current standard of care tests - Choline PET and Bone scan.

Transperineal MRI-targeted biopsies and whole-gland transperineal prostate mapping biopsies

Focal salvage HIFU and cryotherapy of recurrent prostate cancer tumors only

Full parametric MRI using T1W, T2W, Diffusion-weighted and dynamic-contrast-enhanced images at 3Tesla

Whole Body MRI

Cryotherapy and HIFU will be used to targeted the areas of tumor only with a margin of normal tissue.

Focal Salvage Therapy

Image registration will be used to target biopsies followed by full mapping biopsies of the prostate. All biopsies will be carried out transperineally

MRI Targeted biopsies

Abi A Kanthabalan, MBChB

Hashim U Ahmed, FRCS, PhD

Richard Hindley, FRCS, MD

Abi Kanthabalan

Manit Arya, FRCS

Mark Emberton, FRCS, MD

Shonit Punwani, FRCR

Radiotherapy is the commonest form of prostate cancer treatment in the UK. In one in four men, radiotherapy will fail to control the cancer. These men are offered hormonal treatment which has significant side effects. Few men are offered a further treatment such as surgery, HIFU or cryotherapy. Only half of these men are cancer free at 5 years. The investigators believe this is due to poor imaging tests such as CT and Bone scan that cannot accurately detect whether cancer has come back inside or outside of the prostate or both. Also radiotherapy damages tissue surrounding the prostate which affects tissue healing for example after surgery. Treating just the cancer in the prostate only (focal treatment) rather than the whole prostate may limit this damage and cause fewer side-effects. The investigators want to see if new imaging tests can better identify cancer that has spread outside of the prostate and areas of cancer inside the prostate. Our new tests are whole-body MRI (for distant disease) and MRI guided biopsies (MRI-TB) (for local disease). First, the investigators will compare the results of whole-body MRI to existing imaging tests (bone-scan, and choline PET/CT) that try to find distant spread. Second, the investigators will compare the results of MRI-TB to a very detailed and accurate biopsy of the prostate called template prostate mapping which will show us where and how aggressive the cancer is. Third, if the cancer is confined to the prostate, the investigators will treat men using focal salvage therapies HIFU and cryotherapy. The investigators believe that these new imaging tests could better identify those who will benefit from early hormone treatment and those who will benefit from local salvage treatment. Our study may help justify carrying out a larger trial looking at how good the treatment is in controlling cancer in the medium and long-term.

FOcal RECurrent Assessment and Salvage Treatment

An Evaluation of a Novel Imaging Based Complex Diagnostic and Therapeutic Pathway Intervention for Men Who Fail Radiotherapy for Prostate Cancer.

Treatment

Continence Presence of urinary incontinence (any pad usage) as determined by the UCLA-EPIC urinary continence questionnaire, at 12 months, in those men with no urinary incontinence at baseline

Whole body MRI lesions suspicious of lymph node, visceral or bone metastases compared to standard care tests

- Sensitivity, specificity, negative and positive predictive values of whole-body MRI to detect distant disease compared to standard care tests (isotope bone-scan, PET/CT-scan, with skeletal survey where appropriate) and/or pelvic lymphadenectomy and/or biopsy of distant areas in indeterminate cases

Imaging of Local Disease

Transperineal multi-parametric MRI targeted biopsies compared to Template Prostate Mapping biopsies in the detection of UCL definition 2 clinically significant prostate cancer (Gleason \>/=3+4 AND/OR Maximum Cancer Core Length \>/=4mm in any one biopsy)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
TUPKRP Combined With MAB Therapy for LUTS/PCa	NCT03701659	Advanced Prosta... Lower Urinary T... Quality of Life Overall Surviva... Progression of ...	Surgery combina... Endocrine thera...	50 Years - 79 Years	The Third Xiangya Hospital of Central South University
FOcal RECurrent Assessment and Salvage Treatment	NCT01883128	Progression of ...	Whole Body MRI Focal Salvage T... MRI Targeted bi...	18 Years -	University College London Hospitals

Spots Global Cancer Trial Database for progression of prostate cancer