Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Disease Progression

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

All Drugs and Chemicals

Somatostatin

Dose escalation study to assess the safety and determine the recommended phase II dose, based on time-to-event Bayesian optimal interval design, with a target toxicity rate of 30%. Three dose levels are planned to be evaluated: 5 MBq (starting dose), 7.5 MBq and 10 MBq (maximum dose allowed). The cohort size will be 3, with a maximum of 10 participants within a same dose level, and a maximum of 18 evaluable participants in total. Participants are planned to receive two cycles of intravenous infusion of 225Ac-DOTATATE every 6 weeks (Q6W). Each dose escalation and potential de-escalation step will be decided based on the dose-limiting toxicities (DLT) rate observed during the study treatment period (84 days following the first infusion), in the current dose cohort.

Two intravenous infusions every 6 weeks (Q6W)

225Ac-DOTATATE

Wendy Delbart, PhD

This study aims to determine the safety and the recommended phase II dose of RYZ101 (actinium-225 labelled DOTA-octreotate (225Ac-DOTATATE)) in participants with refractory and relapsing multiple myeloma (MM) that have received at least 3 prior lines of myeloma therapy. Participants will be selected based on somatostatin receptor (SSTR) positivity assessed by gallium-68 labelled DOTA-octreotate (68Ga-DOTATATE) PET/CT. The response to 225Ac-DOTATATE therapy will also be assessed in the target study population.

A Phase I Study to Assess the Tolerability of 225Ac-DOTATATE in Patients With Refractory and Relapsing Multiple Myeloma Expressing Somatostatin Receptors

Incidence and severity of adverse events (AEs) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0

Rate incidence of dose-limiting toxicities (DLT)

Overall response according to the International Myeloma Working Group (IMWG) response criteria

RayzeBio, Inc.

Jules Bordet Institute

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Lu-PSMA will be administered as a standard-of-care procedure following assessment of suitability by a nuclear medicine physician and managed in close collaboration with the patient's medical oncologist.

177Lu-PSMA

Elizabeth Medhurst

Gaurav Sharma

Gaurav Sharma, Masters

Annette Van Der Heyden, Mgt

Michael Hofman, MBBS, FRACP, FAANMS

This is a descriptive, observational, prospective, open-ended, registry utilising electronic data capture to collect information on the outcomes of men treated with prostate specific-membrane antigen (PSMA) theranostics.

The aim of the registry is to collect data of men with pre-treated metastatic castration-resistant prostate cancer (mCRPC) receiving Lutetium 177 (177Lu)-PSMA outside of a clinical trial to assess "real world" anti-tumour utility. The primary objective is to assess prostate specific antigen (PSA) response rate to 177Lu-PSMA in men with mCRPC.

Patients with mCRPC who have have progression or intolerance on a novel anti-androgen targeted agent (abiraterone and/or enzalutamide and/or apalutamide) will be eligible for the study.

The investigators intend to evaluate the safety of 177Lu-PSMA, in addition to determining patient PSA progression-free survival (PFS), objective radiographic response rates and overall survival (OS). Health-related quality of life (QoL) and pain will also be observed. Additional objectives are to identify biomarkers and assess the relationship between PSMA and F-fluorodeoxyglucose (FDG) Positron Emission Tomography-Computed Tomography (PET/CT) parameters associated with clinical outcomes.

Prognostic and predictive biomarkers associated with treatment outcome and response will be assessed. This will include any of the following:

i. Circulating tumour deoxyribonucleic acid (DNA) ± tumour tissue (DNA repair genes, tumour suppressor genes, androgen receptor); and ii. Whole blood ribonucleic acid (RNA) (androgen receptor splice variants, TMPRSS2:ERG fusion) iii. Blood or histopathology parameters

Men with metastatic castration-resistant prostate cancer (mCRPC).

ProsTIC Registry of Men Treated With PSMA Theranostics

Prostate Cancer Theranostics and Imaging Centre of Excellence (ProsTIC) Prospective Patient Registry of Men Treated With PSMA Theranostics

PET-derived parameters including molecular tumour volume parameters (volume, SUVmax, SUVmean) and other parameters including radiomics from PET, CT, post therapy SPECT/CT or bone scans using data-characterisation algorithms will be assessed

Histological grading of adenocarcinoma of the prostate (obtained via biopsy) using the International Society of Urological Pathology (ISUP) modified Gleason Grades. The cells identified are given a grade number from 1 to 5, depending on the abnormality of the cells, 1 being the lowest, 5 the highest. The grades of the two most common patterns are added together to give a score from 2 to 10. The higher the score, the more aggressive and fast-growing the cancer.

Measurement of prognostic and predictive biomarkers (Circulating tumour deoxyribonucleic acid (DNA) ± tumour tissue (DNA repair genes, tumour suppressor genes, androgen receptor) associated with treatment outcome and response

Measurement of prognostic and predictive biomarkers. Alterations in whole blood ribonucleic acid (RNA) androgen receptor splice variants

Measurement of prognostic and predictive biomarkers. Alterations in whole blood ribonucleic acid (RNA) TMPRSS2:ERG fusion

Prostate specific antigen-response rate (PSA-RR) defined as the proportion of participants with a PSA reduction of ≥ 50 percent from baseline.

Safety of the combination will be measured by selected AEs and SAEs; only grade 3 or greater AEs related to 177Lu-PSMA with the exception of lymphopenia and fatigue or any grade 1-2 AEs that have not previously been reported with 177Lu-PSMA

rPFS is defined as the time from treatment initiation to the first date of documented radiographic progression using conventional imaging or death due to any cause, whichever occurs first. The radiographic progression will be assessed by the investigator per response evaluation criteria in solid tumors (RECIST1.1) for soft tissue and prostate cancer working group three (PCWG3) for bone lesions.

PSA-PFS is defined as the time from treatment initiation to the date of PSA progression per PCWG3 or death due to any cause, whichever occurs first. The date of PSA progression is the date that an increase of 25% or more and an absolute increase of 2ng/mL or more from the nadir is documented. For patients who have an initial PSA decline during treatment, this must be confirmed by a second value 3 or more weeks later.

OS is defined as the time from treatment initiation to the date of death due to any cause.

The European Organization for Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ-C30) includes five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), and a global health and quality-of-life scale. The remaining single items assess additional symptoms commonly reported by cancer patients (dyspnoea, appetite loss, sleep disturbance, constipation, and diarrhoea), as well as the perceived financial impact of the disease and treatment.

All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.

Pain is measured using the McGill-Melzack Present Pain Intensity scale (PPI) Pain Response is defined for patients with a baseline PPI score of ≥2 or a baseline analgesic score of ≥10 points, as: (i) a PPI score reduction of ≥2 points from baseline with no increase in analgesic score; and/or, (ii) a decrease of ≥ 50 percent in analgesic score with no increase PPI.

Peter MacCallum Cancer Centre, Australia

Prostatic Neoplasms, Castration-Resistant

To evaluate the tolerability and safety of 225Ac-PSMA I\&T in patients with metastatic prostate cancer

Radionuclide Therapy

Sui wai Ling

Laurens Groenendijk

Sui wai Ling Ling

225Ac-PSMA I\&T is a radiopharmaceutical for therapy of prostate cancer. PSMA is overexpressed on prostate cancer cells. Actium-225 is an alpha emitting radionuclide. When PSMA I\&T is labelled with Actium-225, it can be applied as therapy for prostate cancer.

Rationale:

225Ac-PSMA I\&T is a radiopharmaceutical for therapy of prostate cancer. PSMA is overexpressed on prostate cancer cells. Actium-225 is an alpha emitting radionuclide. When PSMA I\&T is labelled with Actium-225, it can be applied as therapy for prostate cancer.

Objective:

To evaluate the tolerability and safety of 225Ac-PSMA I\&T in patients with metastatic prostate cancer and recommend a dose for further phase 2 studies.

Study design:

A clinical prospective, single-center, single-arm, phase I dose escalation therapy study.

Study population:

Up to 30 patients with advanced metastatic castration-resistant prostate cancer (mCRPC).

Intervention:

Patients with advanced mCRPC will receive therapy with 225Ac-PSMA I\&T. The first dose-level will not exceed 8 megabecquerel (MBq), as this is reported in the literature as a save activity for treatment. A Positron Emission Tomography - Magnetic Resonance Imaging (PET-MRI) with Gallium-68-PSMA I\&T (68Ga) will be performed to calculate the precise dose-level needed and as a verification the precise dose-level will be compared with the dose-level of 8 MBq. In the first week after therapy, the PET-MRI will be repeated to observe any effects of the alpha radiation on the metastases and observe the potential changes in 68Ga-PSMA I\&T uptake. Eight weeks after the first cycle, patients will receive the second cycle of 225Ac-PSMA I\&T. If no Dose Limiting Toxicity (DLT) occurs, the dose can be increased for the next DL. If a DLT occurs, the cohort will be expanded to 6 patients. After establishing the recommended dose, an expansion cohort will be opened with a total of 12 patients.

Main study endpoints:

To investigate the safety, tolerability and biochemical effects of 225Ac-PSMA I\&T injected in patients with metastatic prostate cancer.

Primary objective:

- To assess the safety and tolerability of 225Ac-PSMA I\&T administered intravenously

Secondary objectives:

* To predict and calculate the absorbed-dose in critical organs (e.g. salivary glands, kidneys, bone marrow) by 68Ga-PSMA I\&T PET-MRI
* To evaluate the effects of the radionuclide therapy on metastases in the days after therapy using 68Ga-PSMA I\&T PET-MRI
* To evaluate the biochemical effects of 225Ac-PSMA I\&T therapy in patients with metastatic prostate cancer

A clinical prospective, single-center, single-arm, phase I dose escalation therapy study.

Actium-225-Prostate Specific Membrane Antigen Imaging & Therapy

Phase I Dose Escalation Study to Evaluate Tolerability and Safety of 225Ac-PSMA I&T in Patients With Metastatic Prostate Cancer

Dutch Cancer Society

Erasmus Medical Center

Principal Investigator

Pluvicto

Radiopharmaceuticals

Patients 1-10 will be given 5GBq of 177Lu-PSMA. Patients 11-20 will be given 2 cycles of 5GBq of 177Lu-PSMA, separated by 6 weeks.

177Lu-PSMA-617

Declan Murphy

Michael S Hofman

John Violet

This clinical trial will evaluate the dosimetry, efficacy and toxicity of Lu-PSMA in men with high PSMA-expressing high-risk localized or locoregional advanced prostate cancer (HRCaP) undergoing radical prostatectomy (RP) and pelvic lymph node dissection (PLND)

This open label, phase I/II non-randomised clinical trial will evaluate the dosimetry, efficacy and toxicity of Lu-PSMA in men with high PSMA-expressing high-risk localized or locoregional advanced prostate cancer (HRCaP) undergoing radical prostatectomy (RP) and pelvic lymph node dissection (PLND). Patients will receive one or two cycles of 177Lu-PSMA followed by surgery. The primary objective is to determine the radiation absorbed dose in the prostate and involved lymph nodes. Secondary objectives include evaluating imaging response to therapy using PSMA-PET, biochemical response, pathological response, adverse effects of Lu-PSMA and surgical safety, and health-related Quality of Life (QoL).

Dosimetry, Safety and Potential Benefit of 177Lu-PSMA-617 Prior to Prostatectomy

Study of the Dosimetry, Safety and Potential Benefit of 177Lu-PSMA-617 Radionuclide Therapy Prior to Radical Prostatectomy in Men With High-risk Localised Prostate Cancer

Biochemical recurrence (BCR) will be measured from the time of surgery to the first rise of the PSA to ≥0.2 ng/mL

Determination of the relationship between screening PSMA PET imaging parameters including molecular tumour volume parameters and absorbed dose in the prostate and involved lymph nodes

Determination of relevant predictive biomarkers associated with treatment outcomes and response

Establishing the absorbed radiation dose in the prostate and involved lymph nodes (Gy)

PSMA PET response to therapy (complete metabolic response, partial metabolic response, stable metabolic disease, progressive metabolic disease)

Pathological response (complete response, minimal residual disease)

Assessment of toxicity of Lu-PSMA using Common Terminology Criteria for Adverse Events (CTCAE) v5

Surgical safety will be assessed using using the Clavien-Dindo classification of surgical complications

QoL indices will be scored using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire

QoL indices will be scored using European Organisation for Research and Treatment of Cancer (EORTC) QLQ-PR25 questionnaire

Indices will be scored using the Expanded Prostate Cancer Index Composite (EPIC)-26 questionnaire

Movember Foundation

Medical Research Future Fund

Endocyte

E.J. Whitten Foundation Prostate Cancer Research Centre

Carcinoma

Analgesics

Samarium Sm-153 lexidronam

Lutetium-177 prostate-specific membrane antigen (Lu177 PSMA) radioligand therapy (RLT) according to standard local protocol

Actinium-225 prostate-specific membrane antigen (Ac225 PSMA) radioligand therapy (RLT) according to standard local protocol

Combined Lu177 / Ac225 PSMA radioligand therapy according to standard local protocol

Bone-targeted Radium-223 (Ra223) radionuclide therapy in standard application

Bone-targeted Samarium-153 (Sm153) EDTMP radionuclide therapy in standard application

Radioembolization with yttrium-90 (Y90) microspheres, standard methodology

Terbium-161 prostate-specific membrane antigen (Tb161 PSMA) radioligand therapy (RLT) according to standard local protocol

Samer Ezziddin, MSc, MD, PhD

Katja Threm

This prospective registry aims to assess outcome and toxicity of targeted radionuclide therapies in patients with advanced prostate cancer in clinical routine. While the major investigated treatment modality is prostate-specific membrane antigen (PSMA)-targeted radioligand therapy, also other radionuclide therapies such as Ra223 and liver-directed radioembolization are included. The investigators believe that prospectively assessed long-term outcome data on implementation of radionuclide therapy, especially in the palliative setting of advanced mCRPC, help to better define the real benefits and risks of the respective treatment modalities for patients regarding survival and quality-of-life.

Targeted radionuclide therapy is comprised of different modalities that may be applied in advanced prostate cancer, either targeting bone metastases (mainly using Radium-223), any site of metastases with PSMA-expression (ß- / alpha-emitter labelled radioligands) or loco-regionally applying internal radiation (Yttrium-90 microspheres) to metastatic liver disease. While in Germany, each form of treatment is used in clinical routine, data is sparse regarding the real benefits and risks of respective modalities, also when used in a sequential order. As an example, patients receiving Ra223 treatment may later undergo PSMA targeted radioligand therapy, with little data available on dependent response relationships or cumulative risks. Prospective assessment of outcomes and toxicities in a radionuclide therapy registry is apparently superior over retrospective analyses of selected patient populations.

The goal of the REALITY study is to gain a better understanding of the real-life clinical application of radionuclide therapies, with a focus on PSMA-targeted radioligand therapy in a high-volume treatment centre, and the impact of each treatment for patient outcome.

Based on primary and secondary outcome measures the potential prediction of treatment benefit by baseline patient and tumor characteristics, and early changes of biomarkers will be of interest.

Prospective REgistry of Targeted RadionucLide TherapY in Patients With mCRPC (REALITY Study)

REALITY Study: Analysis of a Prospective REgistry to Assess Outcome and Toxicity of Targeted RadionucLide TherapY in Patients With mCRPC in Clinical Routine.

Best PSA response and PSA response after 3 months from start of radionuclide therapy

PSA-based progression-free survival (PFS) according to PCWG3 criteria. From date of start of radionuclide therapy until documented and confirmed PSA-progression

Overall survival. From date of start of radionuclide therapy until the date of death from any cause assessed

All toxicity occurring after start of radionuclide treatment will be registered according to the Common Terminology Criteria for Adverse Events (CTCAE version 4.03).

Rate of toxicity-related discontinuation of radionuclide therapy

Response to radionuclide therapy based on conventional imaging according to RECIST 1.1

Response to radionuclide therapy based on molecular imaging

Quality-of-life assessed from start of radionuclide treatment by EORTC QLQ-C30 questionaires

Based on VAS-BPI patient questionaires from start of radionuclide treatment

Absorbed doses in Gy/GBq based on intra- / posttherapeutic dosimetry when available

Universität des Saarlandes

Director, Dept. of Nuclear Medicine

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

Capecitabine

Fluorodeoxyglucose F18

Edotreotide

Edotreotide lutetium LU-177

Antimetabolites

Patients with 68Ga-DOTA- and 18F-FDG-PET-positive NET will receive a combination of intravenous 7.5 GBG (gigabequerel) 177Lu-DOTATOC for about 7 cycles in combination with capecitabine (4 cycles, cycle length 3 weeks, with one week without capecitabine, dosing 825 mg twice daily) and PRRT to a cumulative renal AD (absorbed dose) limit of 30 Gy and dosimetry-based PRRT.

.

Intravenous infusion for about 7 treatment cycles with 7.5 GBq 177Lu-DOTATOC with an interval of 10 ± 2 weeks and PRRT to a cumulative renal AD limit of 30 Gy and dosimetry-based PRRT.

Standard treatment of 177Lu-DOTATOC with treatment for 4 cycles.

The investigational medicinal product (IMP) is 177Lu-DOTATOC which is registered as an orphan drug by the EMA ( European Medicines Agency) for the treatment of GEP-NEN (gastro-entero-pancreatic neuroendocrine tumor).

The IMP will be administered to participants both in the control arm and the experimental arms, but with different intervals, but the same activity; 7.5 Gbq per dosing.

177Lu-DOTATOC

Will be given orally with a dose of 825/m2 twice daily, starting on day 1 of each of the 4 first treatment cycles, cycle length 3 weeks.

There are several ways of personalizing PRRT (peptide receptor radionuclide treatment) in NEN (neuroendocrine neoplasia). Nevertheless, the current treatment regimen is not personalized. This trial aims to compare personalized PRRT to non-personalized PRRT in terms of safety, efficacy and resource demands in order to optimize treatment outcomes in an evidence-based manner in future.

This is a randomized, open-label, controlled trial in which patients are assigned to either non-personalized treatment with 4 cycles of 7.5 gigabequerel (GBq) 177Lu-DOTATOC (TOC), or personalized treatment based on dual imaging. In the personalized arm patients are treated according to the results of the dual imaging at screening:

A. Patients with 68Ga-1,4,7,10-tetra-azacyclododecane-N.n,N,N-tetraacetic acid (DOTA)-positron emission tomography (PET)-positive but 18F-2-fluoro-2-deoxy-D-glucosefluorodeoxyglucose (FDG)-PET-negative NET will receive dosimetry-based PRRT only (dTOC) B. Patients with 68Ga-DOTA- and 18F-FDG-PET-positive NET will receive a combination of capecitabine and dosimetry-based PRRT (CAP-dTOC).

Systemic Targeted Adaptive RadioTherapy of NeuroEndocrine Tumors.

Systemic Targeted Adaptive RadioTherapy of NeuroEndocrine Tumors. An Open-label, Multicenter, Randomized Phase III Trial Comparing Safety and Efficacy of Personalized Versus Non-personalized Radionuclide Therapy With 177Lu (Lutetium)-DOTATOC.

Time to progression is evaluated by CT (computed tomography) or MRI (magnetic resonance imaging) after every 16-22 weeks.

Time to progression is evaluated by CT (computed tomography) or MRI (magnetic resonance imaging) after every 10 +/- 2 weeks.

Treatment-related adverse reactions graded according to CTCAE v.5.0.

Median OS defined as time from randomization to death of any cause.

Percent change in SLD from baseline (within 4 weeks before treatment) to time of best response.

All patients complete the Eastern Cooperative Oncology Group (EORTC) QoL (quality of life)-questionnaires GI- neuroendocrine tumors (NET)21.

AD to target tumor lesions in subjects with complete remission (CR), partial remission (PR), stable disease (SD) and progressive disease (PD) as best response, according to RECIST evaluations.

Correlation between cumulative median absorbed dose to target tumor lesions and time to progression, defined as time from randomization to radiological progression.

Cumulative median AD and biological effective dose (BED) to kidneys vs rate of grade 3-4 renal toxicity (estimated and measured GFR ( glomerular filtration rate).

Differences in resource utilization and treatment cost between the two treatment arms, in relation to the progressive free survival (PFS) and overall survival (OS).

Lund University Hospital

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Nasopharyngeal Carcinoma

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Neoplasms, Glandular and Epithelial

Lutetium Lu 177 dotatate

Treatment with 177Lu-DOTATATE consist of a cumulative dose of 23.68 - 29.6 GBq (640 - 800 mCi) 177Lu-DOTA0-Tyr3-Octreotate; Four administrations of 5.92 - 7.4 GBq (160 - 200 mCi) 177Lu-DOTA0-Tyr3-Octreotate; Concomitant amino acids will be given with each administration for kidney protection; 177Lu-DOTA0-Tyr3-Octreotate will be administered at 8±1-week intervals, which can be extended up to 16 weeks to accommodate resolving acute toxicity.

Treatment will consist of a cumulative dose of 23.68 - 29.6 GBq (640 - 800 mCi) 177Lu-DOTA0 -Tyr3-Octreotate; Four administrations of 5.92 - 7.4 GBq (160 - 200 mCi) 177Lu-DOTA0-Tyr3-Octreotate; Concomitant amino acids will be given with each administration for kidney protection; 177Lu-DOTA0-Tyr3-Octreotate will be administered at 8±1-week intervals, which can be extended up to 16 weeks to accommodate resolving acute toxicity.

77 Lu-DOTA0-Tyr3-Octreotate

Daniel Tan, BSc, MBBS, PhD

Wen-Long Nei

Wen-Long Nei, MBBS, FRCR

Kelvin Loke, MBBS, MRCP(UK), FAMS

This study is the first phase II study of 177Lu-DOTA0-Tyr3-Octreotate in metastatic NPC. Patients whom have failed 2 or more lines of therapy or exhausted standard therapy and are avid on 68Ga-DOTATATE imaging will be eligible to receive up to 4 cycles of 177Lu-DOTA0-Tyr3-Octreotate. The primary outcome will be progression free survival at 6 months.

This would be an open label, single arm, single centre, phase II study designed to evaluate the efficacy of 177Lu-DOTA0-Tyr3-Octreotate in Metastatic NPC.

Patients will first need to go for a 68Ga-DOTATATE scan to determine if they are suitable for 177Lu-DOTA0-Tyr3-Octreotate therapy. A'Hern single stage phase II design (A'Hern, 2001) will be used for conducting the trial. The null hypothesis that the true PFS rate at 6 months is 10% will be tested against the alternate hypothesis of 25%. A total number of 25 patients will be recruited. If there are 5 or more patients who are alive and progression free among these 25 patients at 6 months, we reject the null hypothesis and claim that the treatment is promising.

The design controls the type I error rate at 9.8% and yields a power of 78.6% when the true PFS rate at 6 months is 25%. The first 5 patients will receive 180mCi of 177Lu-DOTA0-Tyr3-Octreotate for the first cycle followed by 200mCi for the remaining 3 cycles if there are no \> Grade 2 toxicities after the first cycle. If there are \>G2 toxicities, the remaining cycles will proceed at 180mCi. A safety review will be done after the first 5 patients. If there are no significant toxicities, the remaining patients will receive 200mCi for 4 cycles. If there are significant toxicities in patients receiving 200mCi for the 2nd to 4th cycle, the remaining patients will receive 180mCi for 4 cycles. If there are significant toxicities in patients receiving 180mCi for the 2nd to 4th cycle, the remaining patients will receive 160mCi for 4 cycles. Dosimetry scans will be done after each cycle of 177Lu-DOTA0-Tyr3-Octreotate at 1h and 96h. Safety and tolerability of 177LuDOTA0-Tyr3-Octreotate will be assessed for the duration of study treatment.

FDG PET/CT scan and 68Ga-DOTATATE scan will be performed at baseline and after cycle 1 (week 4) and cycle 4 (week 28). CT scans will be done at week 12, 24, then 3-monthly starting from week 40. 177Lu-DOTA0-Tyr3-Octreotate treatment will be continued until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, dose adjustment is permitted. A treatment cycle is eight weeks (56 days) and will be repeated without therapy interruption for 4 cycles unless there is dose limiting toxicities.

Phase II 177Lu-DOTATATE Study in Metastatic NPC With a Safety Run-in

A Biomarker Enrichment, Phase II Study of 177Lu-DOTATATE in Metastatic Nasopharyngeal Cancer With a Safety Run-in

PFS is defined as the time from the date of initiating study treatment to the date of documented disease progression as determined by RECIST Criteria, Version 1.1 or death from any cause.

Point estimates for median PFS and PFS rate at 6 month, with corresponding 95% Confidence Intervals (CIs), will be estimated using the Kaplan-Meier method.

ORR is defined as the percentage of patients who had a partial response or complete response according to RECIST 1.1.

The ORR and 95% CI will be calculated.

TTP is defined as the time (number of days) from start of study treatment to objective tumour progression.

OS is defined as the time from the date of start of study treatment to the date of death due to any cause or the date of last contact (censored observation) at the date of data cut-off.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase I Study to Assess the Tolerability of 225Ac-DOTATATE in Patients With Refractory and Relapsing Multiple Myeloma Expressing Somatostatin Receptors	NCT06411301	Multiple Myelom... Multiple Myelom... Multiple Myelom...	225Ac-DOTATATE	18 Years -	Jules Bordet Institute
ProsTIC Registry of Men Treated With PSMA Theranostics	NCT04769817	Prostate Cancer Metastatic Cast...	177Lu-PSMA	18 Years -	Peter MacCallum Cancer Centre, Australia
Actium-225-Prostate Specific Membrane Antigen Imaging & Therapy	NCT05902247	Prostatic Neopl...	Radionuclide Th...	18 Years -	Erasmus Medical Center
Dosimetry, Safety and Potential Benefit of 177Lu-PSMA-617 Prior to Prostatectomy	NCT04430192	Prostatic Neopl...	177Lu-PSMA-617	18 Years -	Peter MacCallum Cancer Centre, Australia
Prospective REgistry of Targeted RadionucLide TherapY in Patients With mCRPC (REALITY Study)	NCT04833517	Prostate Cancer... Castration Resi... Advanced Prosta...		18 Years -	Universität des Saarlandes
Systemic Targeted Adaptive RadioTherapy of NeuroEndocrine Tumors.	NCT05387603	Neuroendocrine ...	177Lu-DOTATOC Capecitabine	18 Years -	Lund University Hospital
Dosimetry, Safety and Potential Benefit of 177Lu-PSMA-617 Prior to Prostatectomy	NCT04430192	Prostatic Neopl...	177Lu-PSMA-617	18 Years -	Peter MacCallum Cancer Centre, Australia
A Phase I Study to Assess the Tolerability of 225Ac-DOTATATE in Patients With Refractory and Relapsing Multiple Myeloma Expressing Somatostatin Receptors	NCT06411301	Multiple Myelom... Multiple Myelom... Multiple Myelom...	225Ac-DOTATATE	18 Years -	Jules Bordet Institute
ProsTIC Registry of Men Treated With PSMA Theranostics	NCT04769817	Prostate Cancer Metastatic Cast...	177Lu-PSMA	18 Years -	Peter MacCallum Cancer Centre, Australia
Actium-225-Prostate Specific Membrane Antigen Imaging & Therapy	NCT05902247	Prostatic Neopl...	Radionuclide Th...	18 Years -	Erasmus Medical Center
Systemic Targeted Adaptive RadioTherapy of NeuroEndocrine Tumors.	NCT05387603	Neuroendocrine ...	177Lu-DOTATOC Capecitabine	18 Years -	Lund University Hospital
Phase II 177Lu-DOTATATE Study in Metastatic NPC With a Safety Run-in	NCT05198479	Metastatic Naso...	77 Lu-DOTA0-Tyr...	21 Years - 75 Years	National Cancer Centre, Singapore

Spots Global Cancer Trial Database for radionuclide therapy