Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Recurrence

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Disease Attributes

Patients will receive a single administration of 200 megabecquerels (MBq) of 64Cu-SAR-bisPSMA.

64Cu-SAR-bisPSMA

The aim of this study is to determine the safety and efficacy of 64Cu-SAR-bisPSMA and determine the ability of 64Cu-SAR-bisPSMA Positron emission tomography (PET)/computed tomography (CT) to correctly detect the recurrence of prostate cancer in participants with biochemical recurrence of prostate cancer following definitive therapy.

64Cu-SAR-bisPSMA for Identification of Participants With Recurrence of Prostate Cancer (COBRA)

64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 1/2 Study of Participants With Biochemical Recurrence of Prostate Cancer

Adverse Events will be as assessed by CTCAE version 5.0

Proportion of true positive participants on the Day 0 scan out of all participants with a Day 0 scan.

Proportion of true positive participants on the Day 1 scan out of all participants with a Day 1 scan.

Proportion of true positive regions on the Day 0 scan out of all positive regions on the Day 0 scan

Proportion of true positive regions on the Day 1 scan out of all positive regions on the Day 1 scan

Clarity Pharmaceuticals Ltd

Carcinoma

All Drugs and Chemicals

Gallium 68 PSMA-11

Radiopharmaceuticals

111 \~ 259 MBq 68Ga-PSMA-11 will be administered intravenously to participants over 3- 5 minutes.

After 50-100 minutes post 68Ga-PSMA-11 injection, participants will be scanned (PET/CT or PET/MRI) from the mid-thigh to the apex of the skull. Participants will be placed in a supine position with the arms raised overhead.

A single dose of 111 - 259 MBq administered intravenously over 3 -5 minutes

68Ga-PSMA-11

PET/CT or PET/MRI will be acquired no sooner than 50 minutes post injection and not later than 100 minutes post injection with 68Ga-PSMA-11

PET/CT or PET/MRI

Principal Investigator

Shuo Hu

Wanlong Tan

PI PI

Shaolin Song

Minggang Su

Pengfei Shen

Xiaoli Lan, MD

Yong He

This is a prospective, open-label, single-arm, multicenter bridging study in Chinese patients with prostate cancer. This multicenter study is planned to be conducted in patients with biochemical recurrence (BCR) of elevated PSA after radical prostatectomy or radical radiotherapy. This study investigates how well 68Ga-PSMA-11 PET/CT works in detecting BCR prostate cancer in Chinese patient. 68Ga-PSMA-11, developed by Telix, is a new molecular entity tracer with the trade name Illuccix®, which is approved by FDA for the examination of: 1) patients with suspected metastatic PC who are scheduled for initial treatment; 2) patients with biochemical recurrence of elevated PSA levels after initial radical radiotherapy.

This study aims to recruit 110 prostate cancer patients with elevated PSA (BCR) after radical prostatectomy or radical radiotherapy

68Ga-PSMA-11 Efficacy in Detecting BCR Prostate Cancer in Chinese Patients

A Prospective, Open-Label, Single-Arm, Multi-center Study to Evaluate the Diagnostic Efficacy and Safety of 68Ga-PSMA-11 PET/CT or PET/MRI in Patients With Biochemical Recurrent Prostate Cancer

The PPV \[PPV (%) = TP\* /(TP + FP\*\*)\] will be determined by the combination of histopathology/biopsy and conventional imaging and/or PSA follow-up results as the true criteria (composite criteria) and the results observed by 68Ga-PSMA-11 PET (positive/negative).

Safety will be reported descriptively as rates of patient reported adverse events. Additionally, adverse events will be characterized and quantified by Common Terminology Criteria for Adverse Events

The impact of 68Ga-PSMA-11 PET/CT or PET/MRI on clinical management in biochemical recurrence patients will be assessed through the completion of Medical Management Questionnaires completed prior to and after 68Ga-PSMA-11 PET/CT or PET/MRI.

Grand Pharmaceutical (China) Co., Ltd.

Telix Pharmaceuticals (Innovations) Pty Limited

Patients will receive a single administration of 200 megabecquerels (MBq) of 64Cu-SAR-BBN.

64Cu-SAR-BBN

The aim of this study is to determine the safety and efficacy of 64Cu-SAR-BBN and determine the ability of 64Cu-SAR-BBN Positron emission tomography (PET)/computed tomography (CT) to correctly detect the recurrence of prostate cancer in participants with PSMA-negative biochemical recurrence of prostate cancer following definitive therapy.

64Cu-SAR-BBN for Identification of Participants With Recurrence of Prostate Cancer (SABRE)

64Cu-SAR-BBN Positron Emission Tomography: A Phase 2 Study of Participants With PSMA-negative Biochemical Recurrence of Prostate Cancer

Urologic Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urologic Diseases

Antineoplastic Agents

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Pembrolizumab 200mg i.v. three-weekly in combination with salvage radiation therapy (SRT) according to standard of care

Up to 17 cycles of pembrolizumab until disease progression, toxicity, death, or withdrawal of IC (whichever occurs first)

Pembrolizumab Injection [Keytruda]

SRT according to standard of care (SRT with at least 66 Gy)

Salvage Radiation Therapy (SRT)

Markus T Grabbert, Dr.

Anika Josef, Dr.

Markus T Grabbert, Dr. med.

Anika Josef, Dr. phil.

Christian Gratzke, Prof. Dr.

To evaluate the efficacy and safety of a pembrolizumab therapy of pembrolizumab in combination with standard salvage radiation therapy (SRT) in patients with biochemical recurrence (BCR) of prostate-specific antigen (PSA) persistence after radical prostatectomy (RP).

Current guidelines recommend a salvage radiation therapy (SRT) with at least 66 Gy as preferred treatment option in patients with biochemical recurrence (BCR) resp. PSA (prostate-specific antigen) persistence after radical prostatectomy (RP). The guideline recommendation is based on two non-randomized controlled trials that showed an improved cancer-specific survival and a better local tumor control. The optimal timing for a radiation therapy cannot be clearly defined by the available literature. A radiation therapy as early as possible with a PSA level \<0,5 ng/ml seems to be beneficial. The guideline recommendation is based on two non-randomized controlled trials that showed an improved cancer-specific survival and a better local tumor control. A complete biochemical response is to be expected in approx. 60-70% of patients after 12 months.

The established imaging modality in patients with BCR used to be computed tomography of the abdomen and bone scintigraphy for the detection of skeletal lesions. The introduction of PSMA PET/CT (prostate-specific membrane antigen positron emission tomography combined with CT) has changed the imaging in patients with recurrent prostate cancer and several studies could show improved oncological results compared to patients undergoing standard treatment without positron emission tomography (PET) positive lesions with a 10% improvement in biochemical recurrence-free survival after 2 years.

Immunotherapy alone has not yet proven to be efficacious in prostate cancer as a monotherapy in smaller studies. Several trials could show that the combination of the immunotherapy and radiation therapy has the potential to provide a synergistic effect in treating genitourinary malignancies, whereas more studies are needed to uncover the exact underlying mechanism. In brief, radiation therapy of the location of recurrence increases the tumor´s immunogenic potential and a systemic immunological reaction is initiated that leads to an increased activity of the immune system against tumor tissue (abscopal effect). Lately several trials have been evaluating a possible synergistic effect with tolerable side-effects. A trial combining those two treatment regimens in the early treatment of prostate cancer recurrence is not available up to date.

The clinical benefit of concomitant androgen deprivation therapy (ADT) is controversial and literature failed to show a clear overall survival benefit for all patients. Several retrospective trials have been evaluating a concomitant ADT and for patients with risk factors like suspicious lymph-nodes in staging diagnostics. Several studies have been evaluating the effect of concomitant ADT though. Shipley et al. could show the addition of 24 months of bicalutamide to SRT resulted in significantly higher rates of long-term overall survival. However, sub-group analyses revealed that this effect counts mainly for patients with PSA of \>0.7 ng/ml before SRT. The GETUG-AFU trial did not find any survival benefit for short term (6 months) ADT additionally to SRT. However, a significant benefit in progression-free survival after 120 months of follow-up time was reported. A combination therapy of pembrolizumab and radiation therapy has not been evaluated before in this patient population. The investigators hypothesize that this combination is more effective than radiation therapy alone due to a radiogenic triggered immunomodulation which increases the anti-tumor effect of pembrolizumab. For patients with BCR or PSA persistence after RP no such treatment regimen has been tested yet.

The trial is designed as a phase II, open-label, monocentric, single-arm trial evaluating a combination therapy of pembrolizumab and salvage radiation therapy (SRT) in patients with biochemical recurrence (BCR) or persisting prostate-specific antigen (PSA) after radical prostatectomy (RP).

SRT in Combination With Pembrolizumab in Patients With Recurrent Prostate Cancer After Radical Prostatectomy

Radiotherapy in Combination With Pembrolizumab in Patients With PSA Persistence or Biochemical Recurrence After Radical Prostatectomy Due to Prostate Cancer

The PSA-nadir is defined as the lowest PSA-level measured after start of pembrolizumab administration.

The time to PSA-nadir is defined as the time from start of pembrolizumab administration to this time point.

Number of administered pembrolizumab cycles.

Cumulative dose as sum of all pembrolizumab doses given.

Cumulative dose as sum of all pembrolizumab doses given divided by the time under pembrolizumab treatment (last date minus first date of administration).

Number of patients with dose change of pembrolizumab along with reasons for dose change.

Number of patients with interruptions of pembrolizumab administration along with reasons for dose interruptions.

Cumulative dose of ADT after month 6 after start of pembrolizumab administration.

Time from month 6 after start of pembrolizumab administration to start of ADT.

Cumulative dose of ADT after start of pembrolizumab administration.

Time from start of pembrolizumab administration to start of ADT.

Quality of life of patients will be evaluated using the Functional assessment of cancer therapy - prostate cancer (FACT-P questionnaire. The scoring and the analysis of the total score and the subscale scores will be performed according to the scoring manual available from www.facit.org.

Minimum value: 0, Maximum value (FACT-P Trial Outcome Index, TOI): 104, Maximum value (FACT-G total score): 108, Maximum value (FACT-P total score): 156, High score indicates better outcome.

number of patients with complete biochemical response defined as a PSA level below limit of detection.

Patients will be counted as a responder with respect to the primary endpoint, if the PSA level is below the limit of detection at week 60 (± 2 weeks) after start of trial treatment. Patients will be counted as a non-responder with respect to the primary endpoint, if the PSA level is above the limit of detection at week 60 (± 2 weeks).

The probability of radiographic progession-free survival at week 60 (+/- 2 weeks) after start of treatment will be estimated as the number of patients who are alive and progression-free divided by the total number of treated patients.

Merck Sharp & Dohme LLC

Prof. Dr. med. Christian Gratzke

Adenocarcinoma

Micronutrients

Mineral

Copper

Trace Elements

Copper Supplement

Radiopharmaceutical PET imaging tracer injected intravenously for the detection of PSMA expression.

Copper Cu 64 PSMA I&T

Darcy Denner, PhD

This is a prospective, open-label Phase 3 study to evaluate copper Cu 64 PSMA I\&T injection for PET/CT imaging in patients with recurrent prostate cancer after radical prostatectomy or radiation therapy.

The study will include approximately 200 patients with suspected biochemically recurrant prostate cancer. Each patient will be administered an 8 mCi (± 10 percent) intravenous dose of copper Cu 64 PSMA I\&T injection. PET/CT imaging will be acquired for all patients at 1-4 hours ± 15 minutes post copper Cu 64 PSMA I\&T injection.

The PET/CT images will be interpreted independently by three readers blinded to all patient information. Each patient study will be assessed and scored for the detection of prostate cancer. Specifically, each reader will categorize images as "Disease" or "No Disease" based only on tumor uptake of copper Cu 64 PSMA-I\&T. Analysis of the reads will be used for determination of the patient-level correct detection rate and region-level correct localization rate of copper Cu 64 PSMA I\&T PET/CT by comparison to the Reference Standard.

Copper Cu 64 PSMA I&T PET Imaging in Men With Suspected Recurrence of Prostate Cancer

A Phase 3, Multi-Center, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA I&T PET/CT in Men With Biochemical Recurrence of Prostate Cancer

To determine the patient-level correct detection rate (CDR) of copper Cu 64 PSMA I\&T injection PET/CT imaging for the detection of recurrent metastatic prostate cancer between 60 minutes to 240 minutes post injection. The CDR is defined as the percentage of patients who have at least one true PET positive lesion, with exactly localized correspondence between PET imaging and the Composite Reference Standard, regardless of any co-existent false positive findings, out of all patients who are scanned.

To determine the region-level correct localization rate (CLR) of copper Cu 64 PSMA I\&T injection PET/CT imaging for the detection of recurrent metastatic prostate cancer between 60 and 240 minutes post injection. The CLR is defined as the percentage of regions containing at least one true PET positive lesion, with exactly localized correspondence between PET/CT imaging and the Composite Reference Standard regardless of any co-existent false positive findings, within the same region, out of all regions containing at least one PET positive finding.

Comparison of patient level CDR and region level CLR of copper Cu 64 PSMA I\&T PET/CT stratified by Prostate-Specific Antigen level.

Comparison of patient-level CDR and region level CLR of copper Cu 64 PSMA I\&T PET/CT separated into subgroups of patients with histopathology available and unavailable.

Reader kappa statistics of copper Cu 64 PSMA I\&T PET/CT scan interpretation by the blinded independent readers.

Treatment-emergent adverse events (AEs) will be assessed and graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
64Cu-SAR-bisPSMA for Identification of Participants With Recurrence of Prostate Cancer (COBRA)	NCT05249127	Biochemical Rec...	64Cu-SAR-bisPSM...	18 Years -	Clarity Pharmaceuticals Ltd
68Ga-PSMA-11 Efficacy in Detecting BCR Prostate Cancer in Chinese Patients	NCT05847348	Biochemical Rec... Prostate Cancer BCR Prostate Ca...	68Ga-PSMA-11 PET/CT or PET/M...	18 Years -	Telix Pharmaceuticals (Innovations) Pty Limited
64Cu-SAR-BBN for Identification of Participants With Recurrence of Prostate Cancer (SABRE)	NCT05407311	Biochemical Rec...	64Cu-SAR-BBN	18 Years -	Clarity Pharmaceuticals Ltd
SRT in Combination With Pembrolizumab in Patients With Recurrent Prostate Cancer After Radical Prostatectomy	NCT04931979	Urologic Cancer Biochemical Rec...	Pembrolizumab I... Salvage Radiati...	18 Years -	University Hospital Freiburg
Copper Cu 64 PSMA I&T PET Imaging in Men With Suspected Recurrence of Prostate Cancer	NCT06235099	Prostate Cancer Prostate Adenoc... Biochemical Rec...	Copper Cu 64 PS...	18 Years -	Curium US LLC

Spots Global Cancer Trial Database for biochemical recurrence of malignant neoplasm of prostate