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

Antineoplastic Agents

Reproductive Control Agents

All Drugs and Chemicals

Triptorelin Pamoate

Contraceptive Agents

Contraceptive Agents, Female

Contraceptive Agents, Hormonal

Antineoplastic Agents, Hormonal

All enrolled participants will receive one intramuscular (i.m.) injection of containing 22.5 mg 6-month formulation triptorelin pamoate on Day 1.

Triptorelin pamoate 22.5 mg (6-month formulation), i.m. injection, single dose on Day 1.

Triptorelin pamoate (embonate) salt

Ipsen Medical, Director

The main aim of this study is to assess the effectiveness and safety of the 6-month formulation of triptorelin pamoate in Chinese participants with locally advanced or metastatic cancer of the prostate. Participants will receive 1 injection of triptorelin pamoate 6-month formulation.

Effects of Triptorelin Pamoate 6-month When Given to Adult Chinese Participants With Advanced Cancer in the Prostate

A Multicentre, Open-label, Single-arm Study to Investigate the Efficacy and Safety of Triptorelin Pamoate 22.5 mg 6-month Formulation in Chinese Patients With Locally Advanced or Metastatic Prostate Cancer

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

Percentage of participants with clinically significant change in laboratory parameters (blood chemistry, hematology and coagulation) will be reported. The clinical significance will be decided by the investigator.

Percentage of participants with clinically significant changes in physical examination findings will be reported. The clinical significance will be decided by the investigator.

Percentage of participants with clinically significant changes in ECG readings will be reported. The clinical significance will be decided by the investigator.

Percentage of participants with clinically significant changes in Vital Signs will be reported. The clinical significance will be decided by the investigator.

Percent change in PSA is defined as the absolute value of difference between the PSA values and the baseline value divided by the baseline value

Tmax will be recorded from the PK blood samples collected.

Cmax will be recorded from the PK blood samples collected.

AUC0-169 will be recorded from the PK blood samples collected.

AUClast will be recorded from the PK blood samples collected.

Cmax will be recorded from the PD blood samples collected.

Tmax will be recorded from the PD blood samples collected.

Tcast will be recorded from the PD blood samples collected.

Ipsen

Heart and Blood Diseases

Carcinoma

Mitral Valve Insufficiency

Amino Acids

Bicalutamide

Gefitinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Iressa

AstraZeneca Norway Medical Director, MD

The purpose of this study is to determine if the addition of ZD1839 Iressa™ to standard treatment with Casodex® (bicalutamide) for locally advanced prostate cancer can detect a difference in the rate of decrease of prostate specific antigen (PSA) levels.

Combination Casodex® and Iressa™ in Locally Advanced Prostate Cancer

A Randomized Placebo Controlled Study to Assess the Rate of PSA Decrease, Anatomical & Metabolic Changes in the Prostate Determined by MRI/3D-MRS & Histological Changes by Biopsy in Subjects With Locally Advanced Prostate Carcinoma Treated With Either Casodex® (Bicalutamide) Alone or the Combination of Casodex® & ZD1839 (Iressa™)

AstraZeneca

Androgens

TNFerade™ Biologic

Beth Manchen

While radiation therapy with androgen ablation (hormone reduction) is the standard method of treating locally advanced prostate cancer. New treatments are being combined with radiation therapy in an effort to further improve the cure rates.

This study proposes to combine an experimental drug, TNFerade™ Biologic, (also called AdGVEGR.TNF.11D or "TNFerade") at different dose (amounts) levels in combination with radiation.

TNFerade™ Biologic is a form of gene transfer therapy that when injected into the tumor has shown to increase the effect of radiation therapy.

TNFerade Biologic to Treat Locally Advanced Prostate Cancer

A PHASE I SAFETY AND TOLERABILITY TRIAL OF RADIOTHERAPY, ANDROGEN DEPRIVATION, AND INTRATUMORAL INJECTIONS OF AdGVEGR.TNF.11D (TNFeradeTM) FOR PATIENTS WITH LOCALLY ADVANCED PROSTATE CANCER

National Institutes of Health (NIH)

GenVec

Paul Fischer, PhD, CEO

Androgen Antagonists

Flutamide

Nonsteroidal Anti-Androgens

As the study investigates the effect of a drug given concomitantly to radiotherapy, all patients will be treated with the same treatment technique and target dose. The preferred treatment technique is intensity modulated radiotherapy (IMRT) + A GnRH-agonist will be given for the duration selected for each patient.

A non-steroidal anti-androgen (e. g. flutamide, bicalutamide) will be given orally one week before the first injection of the GnRH agonist and will be continued for no longer than 8 weeks to protect against flare.

Dose may vary due to availability of different brand names and pharmaceutical forms The start of antiandrogen must be registered as day 1 of treatment in the GnRH agonist arm.

As the study investigates the effect of two drugs given concomitantly to radiotherapy, all patients will be treated with the same treatment technique and target dose. The preferred treatment technique is intensity modulated radiotherapy (IMRT) +a GnRH antagonist will be given for a predefined duration of 18, 24, or 36 months as per institution policy.

Each institution has to adhere to the chosen duration of treatment for all patients throughout the study

a GnRH antagonist will be given for a predefined duration of 18, 24, or 36 months as per institution policy

Degarelix

A non-steroidal anti-androgen (e. g. flutamide, bicalutamide) will be given orally one week before the first injection of the GnRH agonist and will be continued for no longer than 8 weeks to protect against flare.Dose may vary due to availability of different brand names and pharmaceutical forms The start of antiandrogen must be registered as day 1 of treatment in the GnRH agonist arm.

approved GnRH agonist

.As the study investigates the effect of two drugs given concomitantly to radiotherapy, all patients will be treated with the same treatment technique and target dose. The preferred treatment technique is intensity modulated radiotherapy (IMRT)

Radiotherapy

Dirk Boehmer, MD, PhD

Pedro Lara, MD, PhD

Thomas Zilli, MD, PhD

Martin Spahn, MD, PhD

The primary objective of the trial is to assess if GnRH antagonists in combination with external beam radiation therapy improve progression free survival (progression that can be biological, clinical, or death) compared to GnRH agonists in combination with external beam radiation therapy.

Secondary objectives include:

* documentation of effect of GnRH antagonists on clinically significant cardiovascular events in the subgroup of patients at high risk of such events at baseline;
* documentation of side effects and quality of life, I-PSS and urinary tract infections;
* assessment of relative treatment effect on secondary efficacy endpoints (clinical progression, time to next line of systemic therapy, time on therapy, overall and cancer specific survival) and on PSA at 6 months after end of RT.

Phase IIIb randomized stratified open-label comparative 2-arm superiority study with a pre-set non-inferiority boundary.

Registered GnRH antagonists, degarelix, will be given at the dose of 240 mg given as two subcutaneous injections of 120 mg at a concentration of 40 mg/mL on day 1, followed by 80 mg given as one subcutaneous injection at a concentration of 20 mg/mL every 28 days (±2 days).

External beam radiotherapy (EBRT) to a total dose of 78-80 Gy, delivered as one daily fraction, five days a week, started between d1 and months 6 of the androgen deprivation therapy as per institution policy. The irradiation is the same as in the reference therapy arm.

The minimum duration of androgen deprivation with GnRH agonist or antagonist therapy is 18 months.

For each patient, the duration of therapy must be elected upfront by the treating physician among three possible options: 18, 24 or 36 months. The institution shall also declare upfront the duration of the neoadjuvant treatment they intend to deliver to each patient (between 0 and 6 months).

The primary endpoint is progression-free survival defined as the time in days from randomization to death, clinical or biochemical progression, whichever comes first.

Where

* PSA progression based on Phoenix definition, i.e. a rise by 2 ng/mL or more above the nadir PSA (Ref. 17) confirmed by a second value measured minimum 3 months later
* Clinical progression is defined as onset of obstructive symptoms requiring local treatment and demonstrated to be caused by cancer progression or evidence of metastases detected by clinical symptoms and confirmed by imaging
* Start of another line of systemic therapy in absence of progression
* Death due to any cause

Secondary endpoints:

* Clinical progression-free survival
* Time to next systemic anticancer therapy (including secondary hormonal manipulation)
* Proportion of patients switching from GnRH antagonists to GnRH agonists and total effective duration of treatment with the originally allocated drug.
* Overall survival
* Cancer specific survival
* PSA at six months after completion of RT Safety will be scored by the CTCAE version 4.0. The major safety endpoints in this study are
* the incidence of clinical cardiovascular events - CCE (i.e. arterial embolic or thrombotic events, hemorrhagic or ischemic cerebrovascular conditions, myocardial infarction, and other ischemic heart disease) in patients who had cardiovascular events before entering the trial and in those without such events.
* Incidence of urinary tract infection

Trial Comparing Irradiation Plus Long Term Adjuvant Androgen Deprivation With GnRH Antagonist Versus GnRH Agonist Plus Flare Protection in Patients With Very High Risk Localized or Locally Advanced Prostate Cancer

Phase IIIb Randomized Trial Comparing Irradiation Plus Long Term Adjuvant Androgen Deprivation With GnRH Antagonist Versus GnRH Agonist Plus Flare Protection in Patients With Very High Risk Localized or Locally Advanced Prostate Cancer. A Joint Study of the EORTC ROG and GUCG

The primary endpoint is progression-free survival defined as the time in days from randomization to death, clinical or biochemical progression, whichever comes first.

Where

* PSA progression based on Phoenix definition, i.e. a rise by 2 ng/mL or more above the nadir PSA (Ref. 17) confirmed by a second value measured minimum 3 months later
* Clinical progression is defined as onset of obstructive symptoms requiring local treatment and demonstrated to be caused by cancer progression or evidence of metastases detected by clinical symptoms and confirmed by imaging
* Start of another line of systemic therapy in absence of progression
* Death due to any cause

♦ the incidence of clinical cardiovascular events - CCE (i.e. arterial embolic or thrombotic events, hemorrhagic or ischemic cerebrovascular conditions, myocardial infarction, and other ischemic heart disease) in patients who had cardiovascular events before entering the trial and in those without such events.

European Organisation for Research and Treatment of Cancer - EORTC

Symptoms and General Pathology

Recurrence

Prostatic Hyperplasia

Hyperplasia

MRI guided transurethral HIFU ablation is targeted to MRI visible, biopsy proven, index lesion(s) within prostate and if possible with 5mm angular extension (imaging based healthy tissue marginal) to both sides from the tumour boundary in transverse plane and 5 mm in coronal plane. The ablative effect is aimed to reach prostate capsule by heating the control boundary (3 mm from capsule) to temperature 57 °C. The focal approach is intended to be radical as for index lesion.

MRI guided transurethral HIFU ablation is targeted to main prostatic malignant tumour squeezing and/or invading the prostatic urethra and/or bladder neck. The approach is intended to be palliative.

MRI guided transurethral HIFU ablation is targeted to MRI visible, biopsy proven, local recurrent index lesion(s) within and/or surrounding prostate and if possible with 5 mm angular extension to either side from the tumour boundary in transverse plane and 5 mm in coronal plane. The approach is intended to be focal and salvage.

The whole-gland HIFU ablation approach will be considered in case of extensive organ confined recurrent prostate cancer (positive biopsies for malignancy from extensive/multiple area in prostate and/or extensive/multiple lesion(s) at baseline MRI) to cover whole prostate.

MRI guided transurethral HIFU ablation is targeted to adenomas of the prostate. The HIFU sector encompasses bilateral (anterolateral) transitional zones between bladder neck and verumontanum (colliculus seminalis).

The technology is developed to ablate targeted benign and malignant prostate tissue through transurethrally inserted probe that transmit ultrasound energy under MRI guidance and control. The therapeutic endpoint of this method is thermal coagulation of prostate tissue.

MRI guided transurethral HIFU ablation of prostatic tissue

Peter Boström, M.D.Ph.D

This study assesses feasibility and safety, the primary outcomes, of MRI guided transurethral high intensity focused ultrasound (HIFU) ablation for prostate diseases (PD). We will enrol 10 patients to each group with criteria as follows: localised prostate cancer (PC); locally advanced PC; locally recurrent PC after external beam radiation therapy (EBRT); benign prostatic hyperplasia (BPH). Secondary outcomes are both oncologic and functional outcomes and imaging based follow up after HIFU therapy will be also assessed.

Prostate cancer (PC) is the most common cancer among men in Finland with the highest incidence of all cancers. Benign prostate hyperplasia (BPH) also has high prevalence, increasing with age. BPH may cause harmful lower urinary tract symptoms (LUTS) and it is demonstrated that by the age of 60, over 50 % of men have clinically significant prostate BPH and up to 40 % of men over age 60 suffer from LUTS.

Currently curative intended therapies for PC, radiation therapy (RT) and radical prostatectomy (RP), offer desirable oncologic local control but have major impact on genitourinary function and quality of life (QoL). Some patients are unfit for surgical procedures or cannot tolerate RT due to concomitant medical conditions or prior therapies. At present lower risk PC is increasingly managed with active surveillance. However, diagnosis of PC and active surveillance itself may both lead to notable psychological and emotional burden impairing QoL. Further, significant amount of cases in some point end up in radical treatment resulted from either risk profile upgrade or patients preference. For these patients optimal treatment might be a focal therapy with sufficient oncologic control and minor impact on QoL.

There is controversy related to optimal treatment in local recurrence after RT. 45% of patients will have local recurrence after RT within 8 years after treatment. Androgen deprivation therapy (ADT) decelerate disease only temporarily and salvage RP includes major risks and is technically demanding, but can provide long-term cure in selected patients.

On the aspect of palliation, there is an eminent need for less invasive supplementary therapies since patients presenting with metastatic or locally advanced PC, generally have low performance status.

Management of benign prostatic obstruction has also faced challenges with conventional treatment modalities, since ageing and profuse co-morbidities among patients have increased. Transurethral resection of prostate (TURP) is still the standard treatment in severe LUTS caused by BPH.

Recently the major development of magnetic resonance imaging (MRI) has been achieved improving PC diagnosis and local staging. Even though PC is often multifocal, evidence indicates that both clinical outcome and prognosis of PC is determined predominantly by index lesion. Because of the notable risk of morbidities involving radical treatments and significant evolution of MRI, focal therapies have attained wide interest. One of the most interesting focal mini-invasive treatment is high intensity focused ultrasound (HIFU). HIFU technique exploits thermal energy; by raising target temperature over 55°C target volume is destroyed due to acute coagulation necrosis. Modern devices delivering HIFU to the prostate are transurethral and emit directional high intensity ultrasound to the focused regions utilising superior MRI guidance compared to older generation ultrasound guidance. Magnetic resonance thermometry technique utilizes noninvasive measurement of tissue temperature allowing monitoring real time temperature changes during treatment. The MRI treatment system is equipped with active dynamic temperature feedback control designed to maintain a constant temperature inside the target volume and at the boundary of the target area. By this way conformal three-dimensional ablative volumes with great spatial accuracy and precision can be achieved simultaneously avoiding damages to the surrounding sensitive tissues. Therapy verification is confirmed instantaneously after treatment by acquiring contrast enhanced MRI (CE-MRI) that visualise the non-perfused-volume (NPV) describing the success of total ablation of the target prostate volume.

This prospective clinical single center feasibility and safety study will evaluate the role of MRI guided transurethral HIFU ablation for various PD and clinical settings. All enrolled patients have prostate pathology and different clinical situation with need of definitive interventions and they are divided to four arms/groups according to specific inclusion criterion. Group 1 localised PC prior to RP, group 2 symptomatic locally advanced PC in need of palliative surgical intervention, group 3 locally recurrent PC after EBRT and group 4 symptomatic BPH in need for intervention.

The hypothesis is that MRI guided transurethral HIFU is feasible and safe in various prostate diseases and clinical settings. If hypothesis is proven for certain or for all groups, the investigators will continue with that group or groups to phase 2 clinical multi-institutional studies.

This study is an early phase 1 non-randomized prospective single-institutional and four arm study to determine the applicability, feasibility and safety of MRI guided transurethral HIFU ablation of prostate separately in each pre-specified group/arm (10 patients per group).

Due to the encouraging feasibility and safety results, an amendment was made to the original study protocol to increase the amount of salvage group patients and BPH group patients. With the approval of the ethics committee, the sample size of the salvage group and BPH group was increased to a total of 40 patients and 30 patients, respectively.

MRI Guided Transurethral HIFU for Various Prostate Diseases

Feasibility and Safety of Transurethral HIFU in Various Prostate Diseases; Particularly Prostate Cancer

Explore and characterise short- and medium-term pattern of S-PSA response following HIFU ablation. Serum PSA will be measured before HIFU ablation and predetermined interval during follow up protocol after HIFU ablation. The serum PSA trend and nadir following HIFU ablation will be demonstrated.

Voiding function is assessed separately in each group/arm by:

- measuring the rate of flow of voided urine using a flowmeter, a device that measures the quantity of urine (volume) voided per unit time (uroflowmetry). The measurement is expressed in millilitres per second (ml/s).

The data from uroflowmetry before and after HIFU ablation will be compared.

Voiding function is assessed separately in each group/arm by:

- post-voided residual urine (PVR) (volume in ml), which estimates the completeness of bladder emptying using a handheld ultrasonic bladder scanner.

The PVR before and after HIFU ablation will be compared.

Evaluation of QoL using standardised questionnaire:

- 26-item short-form version of EPIC, The Expanded Prostate Index Composite

QoL questionnaire before and after HIFU ablation are compared.

The measure is a composite outcome measure reported as single value for each arm/group.

Quality of life questionnaire, International Prostate Symptom Score (IPSS), is used to assess urinary symptoms following HIFU therapy. IPSS consists of seven question concerning urinary symptoms (points from 0 to 5) and one separate question concerning quality of life (points from 0 to 6). The total score of questions related to urinary symptoms can range from 0 to 35. The baseline IPSS score is compared to IPSS scores obtained from predetermined follow up protocol following HIFU therapy to characterise HIFU therapy´s short- (1 week, 3 and 6 months) and medium-term (12 months) impact on lower urinary tract function. A significant change in IPSS is defined as a change of \> 3 points.

The change in total points of IPSS between baseline and most recent follow up visit is measured.

Quality of life questionnaire, International Index of Erectile Function (IIEF-15), is used to assess sexual function following HIFU therapy. A score of 0-5 is awarded to each of the 15 questions that examine 4 main domain of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.

Change in total score and each domain of IIEF-15 separately are measured between the baseline and most recent follow-up visit.

The pain is assessed predetermined interval during follow up using Visual Analog Scale for pain (VAS for pain, numerical rating scale 1-10).

The measure is a composite outcome measure reported as single value for each arm/group.

Quantitative analysis of targeting accuracy is defined as spatial difference between target prostate region in treatment planning phase and the target temperature isotherm (57°C) at the end of HIFU treatment on MRI thermometry. The measure used is dice similarity coefficient (DSC - unitless from 0 to 1) which is a statistical validation metric to measure the degree of spatial overlap between two regions.

The measure is a composite outcome measure reported as single value for each arm/group.

Quantitative analysis of targeting accuracy volume illustrates over- and under-treatment representing the amount of tissue ≥ target temperature 57°C outside the target volume and \< target temperature 57°C inside the target volume, respectively.

Over- and under-treatment volumes are expressed as a % of the target volume.

The measure is a composite outcome measure reported as single value for each arm/group.

Quantitative analysis of radiologically verified treatment accuracy; determined by comparing targeting volumes on MRI during treatment planning to immediate, 1 and 3 week NPV in CE-MRI following HIFU therapy. The ratio in percentage (%) between target prostate volume (ml) and NPV (ml) will be measured.

Qualitative analysis of treatment accuracy; determined by comparing both targeting volume on MRI during treatment planning and immediate, 1 and 3 weeks NPV following HIFU therapy separately to histopathologically verified coagulation necrosis volume from the removed prostate at 3 week after HIFU therapy. The ratio in percentage between target prostate volume (ml) and NPV (ml) to coagulative necrosis volume (ml) will be measured.

Quantitative analysis of treatment accuracy; determined by comparing targeting volume on MRI during treatment planning to immediate, 1 week and 12 months NPV in CE-MRI following HIFU therapy.

The ratio in percentage between target prostate volume (ml) and NPV (ml) will be measured.

Quantitative analysis of treatment accuracy; determined by comparing targeting volume on MRI during treatment planning to immediate, 1 week and 12 months NPV in CE-MRI following HIFU therapy.

The ratio in percentage between target prostate volume (ml) and non-perfused volume (ml) will be measured.

Quantitative analysis of treatment accuracy; determined by comparing targeting volume on MRI during treatment planning to immediate, 1 week and 12 months NPV in CE-MRI following HIFU therapy. The ratio in percentage between target prostate volume (ml) and NPV (ml) will be measured.

Safety is determined in each group and all group together by evaluation of the frequency and severity of device/treatment related adverse events associated with the use of TULSA-PRO system to ablate prostate tissue. The severity of the adverse events are graded according to the Clavien-Dindo Classification of surgical complications.

The measure is a composite outcome measure reported as single value for each arm/group.

Histopathological evaluation of the treatment response is based on 2-6-core biopsy results obtained from HIFU treated region/volume at 12 months. The number of biopsies taken is depended on the size and extension of the primary lesion treated with HIFU. The cognitive transrectal ultrasound guided biopsy method will be used to confirm histologically anticipated treatment success; coagulative necrosis/fibrosis/scar tissue of the prostate tissue. The outcome of biopsies (negativity/positivity for prostate cancer) will be measured. The proportion of patients with negative prostate biopsy will be measured at 12 months follow-up visit.

Evaluation and characterisation of image based follow up with repetitive mpMRI (Arm/group 1: immediate, 1 and 3 week, Arms/Groups 2, 3 and 4: immediate, 1 week, 12 month) after HIFU treatment. Image based follow up will be focused on modifications and development of the rim of enhancement surrounding NPV and the evolution of NPV following HIFU treatment.

University of Turku

Turku University Hospital

Anti-Inflammatory Agents

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Abiraterone Acetate

Prednisolone

Olaparib

Fluzoparib

Leuprolide

Methylprednisolone

Goserelin

Pamiparib

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Talazoparib

Poly(ADP-ribose) Polymerase Inhibitors

Glucocorticoids

Hormones

Hormone Antagonists

Cytochrome P-450 Enzyme Inhibitors

A total of 100 subjects receive ADT for 6 cycles (28 days per cycle) before prostatectomy. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.

A total of 150 subjects in this group received abiraterone acetate + prednisolone acetate daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.

A total of 50 subjects in this group received enzalutamide daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.

A total of 150 subjects in this group received apalutamide daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.

A total of 150 subjects in this group received darotamide daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.

A total of 150 subjects in this group received rizvilutamide daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.

A total of 100 subjects in this group received Poly ADP-ribose Polymerase (PARP) Inhibitor plus abiraterone along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.

A total of 50 subjects in this group in this group received Poly ADP-ribose Polymerase (PARP) Inhibitor along with ADT mentioned above. Enrolled patients carry homologous recombination repair (HRR) gene mutation verified by molecular testing. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.

The ADT regimen will be determined by the investigators at separate centers. The dose and frequency of administration will be consistent with the prescribing information. Available drugs include triptorelin, goserelin, leuprolide, digareke ect.

1000 mg (250 mg×4 tablets) once daily, orally

Prednisolone tablets

160 mg (40 mg× 4 tablets) once daily, orally.

Enzalutamide

240 mg (60 mg×4 tablets) once daily, orally.

Apalutamide

600 mg (300 mg × 2 tablets) twice daily, orally.

Darotamide

240 mg (80 mg × 3 tablets) once daily orally

Rezvilutamide

The PARP inhibitors will be determined by the investigators at separate centers. The dosage and frequency of administration will be consistent with the prescribing information. Available drugs include olaparib, fluzoparib, pamiparib, talazoparib ect.

PARP inhibitor

Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.

Robot-assisted radical prostatectomy

Junlong Zhuang, MD

This is a prospective, multicenter, multi-arm, non-randomized, open-label clinical trial to evaluate the efficacy and safety of neoadjuvant intense endocrine therapy for high-risk or locally advanced prostate cancer.

The study was designed to evaluate the efficacy and safety of different forms of neoadjuvant intense androgen deprivation therapy (ADT) compared with ADT alone, followed by prostatectomy.

Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer

A Prospective, Multi-arm, Multi-center Clinical Trial on Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer

Pathologic response rate= Pathologic Complete Response (pCR) Rate + Minimal Residual Disease (MRD) rate

Biochemical progression free survival (bPFS) within 3 years

Metastasis-Free Survival (MFS) after intense neoadjuvant therapy

Time to castration-resistant prostate cancer（CRPC) after intense neoadjuvant therapy

Prostate specific antigen (PSA) drops ≥ 98% after intense neoadjuvant therapy

The positive margin rate of whole-mount pathology for prostatectomy after intense neoadjuvant therapy

The pathologic downgrade rate of whole-mount pathology for prostatectomy after intense neoadjuvant therapy compared with initial T stage.

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. All grades of adverse events will be documented.

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Chief Physician

Docetaxel

Tislelizumab

Cisplatin

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Rezvilutamide plus ADT plus tislelizumab.

3.6mg by intramuscular injection once 4 weeks for 24 weeks.

Goserelin Microspheres for Injection

70mg/m2 by infusion every 3 weeks for 6 cycles (each cycle has 3 weeks).

200 mg by infusion every 3 weeks for 6 cycles (each cycle has 3 weeks).

Kaiyan Zhang, M.D.

Haichao Huang, M.D.

To evaluated the safety and efficacy of genomic biomarker-guided neoadjuvant therapy for locally advanced and oligometastatic prostate cancer.

According to the results of the genomic profile, patients will be assigned to 4 neoadjuvant therapy (NT) groups (Queue 1 to 4): Queue 1: No targetable actionable aberration; Queue 2: Homologous recombination repair (HRR) alterations (BRCA1/2); Queue 3: Homologous recombination repair alterations (except BRCA1/2 and CDK12); Queue 4: MSI-H/dMMR, TMB≥10mut/Mb or CDK12 alterations without other HRR alterations. A following PSMA PETCT for evaluating the efficacy of NT and radical prostatectomy (RP) plus pelvic lymph node dissection (PLND) will be perform. The histopathological and survival data after RP plus PLND will also be evaluated.

Genomic Biomarker-guided Neoadjuvant Therapy for Prostate Cancer (SEGNO)

An Exploratory Study of the Safety and Efficacy of Genomic Biomarker-guided Neoadjuvant Therapy for Locally Advanced and Oligometastatic Prostate Cancer (SEGNO)

The rate of clinical complete response (cCR) as assessed using PSMA PET/CT and mp-MRI following 20 weeks of neoadjuvant therapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effects of Triptorelin Pamoate 6-month When Given to Adult Chinese Participants With Advanced Cancer in the Prostate	NCT05590793	Advanced Prosta... Metastatic Pros... Locally Advance...	Triptorelin pam...	18 Years -	Ipsen
Combination Casodex® and Iressa™ in Locally Advanced Prostate Cancer	NCT00319787	Locally Advance...	Iressa	18 Years - 80 Years	AstraZeneca
TNFerade Biologic to Treat Locally Advanced Prostate Cancer	NCT01048151	Locally Advance...	TNFerade™ Biolo...	-	GenVec
Trial Comparing Irradiation Plus Long Term Adjuvant Androgen Deprivation With GnRH Antagonist Versus GnRH Agonist Plus Flare Protection in Patients With Very High Risk Localized or Locally Advanced Prostate Cancer	NCT02799706	Prostate Cancer	Degarelix approved GnRH a... Radiotherapy	18 Years - 80 Years	European Organisation for Research and Treatment of Cancer - EORTC
MRI Guided Transurethral HIFU for Various Prostate Diseases	NCT03350529	Localised Prost... Locally Advance... Locally Recurre... Benign Prostati...	MRI guided tran...	-	Turku University Hospital
Trial Comparing Irradiation Plus Long Term Adjuvant Androgen Deprivation With GnRH Antagonist Versus GnRH Agonist Plus Flare Protection in Patients With Very High Risk Localized or Locally Advanced Prostate Cancer	NCT02799706	Prostate Cancer	Degarelix approved GnRH a... Radiotherapy	18 Years - 80 Years	European Organisation for Research and Treatment of Cancer - EORTC
MRI Guided Transurethral HIFU for Various Prostate Diseases	NCT03350529	Localised Prost... Locally Advance... Locally Recurre... Benign Prostati...	MRI guided tran...	-	Turku University Hospital
Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer	NCT05406999	Neoadjuvant The... High Risk Prost... Locally Advance... Intense Endocri...	ADT Abiraterone Ace... Prednisolone ta... Enzalutamide Apalutamide Darotamide Rezvilutamide PARP inhibitor Robot-assisted ...	18 Years - 80 Years	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Genomic Biomarker-guided Neoadjuvant Therapy for Prostate Cancer (SEGNO)	NCT06387056	Locally Advance... Oligometastatic...	Rezvilutamide Goserelin Micro... Docetaxel Pamiparib Cisplatin Tislelizumab	18 Years -	The First Affiliated Hospital of Xiamen University

Spots Global Cancer Trial Database for locally advanced prostate cancer