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NCT06320067Toboroz3. fázis

A Randomised Controlled Platform Trial Testing Treatments in Metastatic Hormone Sensitive Prostate Cancer

Studying Treatments in Patients Receiving Androgen Deprivation Therapy (ADT) for Metastatic Prostate Cancer: Evaluation of Drug and Radiation Efficacy: A 2nd Multi-arm Multi-stage Randomised Controlled Trial (STAMPEDE2).

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. szept. 26. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még

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Rövid összefoglaló (regiszter, angolul)

STAMPEDE2 is a clinical trial comparing two new treatments with standard of care in people with prostate cancer that has spread to other parts of the body and is responsive to hormone therapy. People from all backgrounds and ethnicities are encouraged to take part and multiple hospitals across the UK are involved. University College London is running the trial. Each comparison within the trial has its own control arm where people get the best standard of care (Arm A) versus a research arm where a new treatment is added to standard of care. Participants are allocated to an arm by a computerised system with a 50% chance of getting the research treatment. Comparison S: Arm A versus Arm S (Stereotactic Ablative Body Radiotherapy (SABR)) - Tests whether giving targeted doses of radiotherapy (SABR) to parts of the body where the cancer has spread slows the spread of the cancer and improves survival. 2476 people will be in this comparison. Comparison P: Arm A versus Arm P (PSMA-Lutetium (177Lu-PSMA-617)) - Tests whether giving a radioactive material (177Lu-PSMA-617) that targets prostate cancer cells slows the spread of the cancer and improves survival. 1756 people will be in this comparison. All participants will be followed up with scans and tests to monitor their cancer. Doctors will check for any side effects from the treatments. Treatments will be stopped if side effects are serious, or people no longer wish to take the treatments.

Állapot (regiszter)
Toboroz
Fázis (regiszter)
3. fázis
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
3360 (tervezett)
Első benyújtás
2024. jan. 10.
Kezdés
2024. jún. 11.
Elsődleges befejezés
2031. ápr.
Fő szponzor
University College, London
Betegségek
Prosztatarák
NCT-szám
NCT06320067
EU CT-szám
2025-522145-21-00

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó · 3. fázis
  • Tervezett résztvevők: 3360
  • 2024. jún. 11. és az elsődleges befejezés (2031. ápr.) között
  • 68 helyszín, 5 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

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Korábbi kezelés

  • Prior radical treatment to the prostate (e.g., radical surgery and/or radiotherapy).
  • Prior treatment to a metastatic site (e.g., radiotherapy, surgery or RFA).
  • Significant or progressive neurological deficit such that emergency (within 24 hours) surgery or radiation required (e.g., metastatic spinal cord compression, or impingement of the cord or any other clinical scenario whereby urgent radiotherapy to the spine is required).
  • If relapsed disease, prior LHRH agonist/antagonist with or without first generation antiandrogen use in the adjuvant/neo-adjuvant setting, hormone treatment must have been discontinued ≥2 years prior to randomisation AND must not have exceeded a total of >3 years of therapy AND must not have shown disease progression within 12 months of completing adjuvant/neo-adjuvant therapy.
  • Prior treatment with any of the following:
    • Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223
    • PSMA-targeted radioligand therapy

Más betegség

  • Patient has relapsed prostate cancer.
  • Intracranial metastatic disease.
  • Any condition or co-morbidities that, in the judgement of the clinician, preclude procedures required to facilitate radiotherapy delivery e.g.:
    • Disease staging and follow-up.
    • Radiotherapy planning procedures.
  • Any condition or co-morbidities that, in the judgement of the clinician, preclude the safe delivery of radiotherapy to the prostate (± pelvic lymph nodes) and/or metastases e.g., inflammatory bowel disease, significant systemic connective tissue disorder, radiological evidence of idiopathic pulmonary fibrosis).
  • Active malignancy other than prostate cancer within the last 36 months.
    • Eligibility Criteria For Comparison P Testing 177LU-PSMA-617:
    • In addition to the general eligibility criteria, patients need to meet the following criteria for entry into Comparison P:
  • Patient meets the definition of SABR ineligible disease.
  • Any condition that precludes raised arms position.

Laborértékek

  • Patients must have adequate organ function as indicated by blood tests within 4 weeks prior to randomisation:
    • Bone marrow function
    • ANC ≥1.5 x 109/L
    • Platelets ≥100 x 109/L
    • Haemoglobin ≥9g/dL, independent of transfusions for at least 28 days Hepatic function
    • <!-- -->
    • Total bilirubin ≤2 x ULN. For patients with Gilbert's Syndrome ≤3 x ULN is permitted.
    • AST and/or ALT performed with all results ≤3 × ULN or ≤5 x ULN for patients with liver metastasis Renal Function
    • <!-- -->
    • EGFR ≥50 mL/min/1.73m2 calculated using the MDRD formula
    • Albumin ≥25g/L

Egyéb

  • Patient still meets all eligibility criteria for registration.
  • Histological confirmation of prostate adenocarcinoma.
  • Patient has started ADT and randomisation is ≤12 weeks since start of current ADT.
  • WHO performance status 0-2 (see Appendix 1).
  • Patient has provided signed informed consent for participation in Comparison P.
  • Symptomatic cord compression, or clinical/radiological findings indicative of impending cord compression.
  • Unmanageable bladder outflow obstruction or urinary incontinence. Note: bladder outflow obstruction or urinary incontinence which is manageable and controlled with best available standard of care (incl. drainage, pads) is permitted.
  • Imaging Sub-study only: Contraindication to MRI (e.g., pacemakers, except MRI compatible pacemakers).

A regiszterben nem jelölt feltételek

  • Registration Inclusion Criteria:
  • At least 18 years old.
  • Histological confirmation of prostate adenocarcinoma or a strong clinical suspicion of prostate cancer with a plan to confirm the diagnosis formally before any future randomisation.
  • Confirmation of metastatic site(s) on CT/MRI and either bone or PET scan. Patients with metastatic disease meeting any of the following criteria are eligible:
    • Metastatic disease to the bone (in any distribution).
    • Non-regional lymph node metastases of any size or distribution. Lymph nodes that are only visible on PET will not be eligible as sites of metastasis. Note: If lymph nodes are the only site of metastases, then at least one must be at least 1.5cm in short axis AND outside of the pelvis.
    • Visceral metastases of any size or distribution.
  • Clinical presentation is:
    • de novo. OR B. relapsed with; (1) continuing hormone sensitivity in the opinion of the investigator, and; (2) all hormone treatments (e.g., ADT and ARPI) will have been completed ≥2 years prior to any future randomisation into any of the comparisons, and; (3) will have received ≤3 years total of ADT at the point of randomisation into any comparison.
    • Note: the dates will be checked again at randomisation. It is the responsibility of the investigator to account for the time between registration and randomisation into any comparison.
  • Long-term androgen deprivation therapy (ADT) has started or there is an intention to start for a minimum of 2 years.
  • WHO Performance Status 0-2 or, if WHO Performance Status 3, deemed to be due to metastatic burden and expected to improve with ADT. Note: Improvement to WHO status 0-2 will be checked again at randomisation into any subsequent comparison.
    • Note: For WHO performance status definitions see Appendix 1.
  • Willing and able to comply with trial treatments.
  • Patient has signed informed consent form for registration into the STAMPEDE2 Trial platform.
    • Registration Exclusion Criteria:
  • Clinically and pathologically overt small cell carcinoma.
  • Metastatic brain disease or leptomeningeal disease.
  • Any active malignancies (i.e., progressing or requiring any treatment in the previous 36 months) other than prostate cancer (except non-muscle invasive bladder cancer; nonmelanomatous skin cancer or a malignancy that is considered cured with minimal risk of recurrence).
  • Any other medical condition that in the investigator's opinion means the participant is unfit or unsuitable for long-term ADT or the trial treatments in the comparison for which they are being considered.
    • Eligibility Criteria For Comparison S Testing SABR:
    • Patients who meet the general eligibility criteria can be considered for the SABR comparison. Recruiting sites will assess metastatic disease burden using CT/MRI scans and baseline Tc-99m bone scan or PET scan to assess number of metastatic bone and non-regional lymph node foci, and presence of visceral metastases. Patients will be classified as either 'SABR-eligible' or 'SABR-ineligible' using the following definition.
    • Definition of SABR-eligible disease:
    • Patients will be classified as SABR-eligible if they meet all the following criteria:
  • 1-5 metastatic lesions (including either bone and/or non-regional lymph node sites).
  • Clinician determination that metastatic lesions are considered suitable for SABR on technical grounds (such as proximity of dose limiting normal tissue or tumour volume). Note: Clinical determination can consider next-generation imaging (e.g., PSMA PET-CT or WBMRI) where available. It is the investigator's responsibility to consider the impact of any findings on the suitability of SABR for the patient. Any next-generation imaging used prior to randomisation should be declared at randomisation so that it can be used as a stratification factor.
  • Absence of visceral metastases.
    • Otherwise, patients will be classified as SABR-ineligible.
    • In addition to the general registration eligibility criteria, they need to meet all the following criteria for entry into Comparison S:
  • Patient still meets all eligibility criteria for registration in Section 4.4.
  • Histological confirmation of prostate adenocarcinoma.
  • Newly diagnosed (de novo) metastatic disease that is considered eligible for SABR according to the above definition.
  • Patient has started ADT and randomisation is ≤12 weeks since the start of ADT.
  • WHO performance status 0-2 (see Appendix 1).
  • Patient has provided signed informed consent for participation in Comparison S.

Életkor a regiszterben: 18 év – - · Nem: csak férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (68)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöRDresdenNémetországToboroz
Universitaetsklinikum Essen (AoR)EssenNémetországToboroz
Universitaetsklinikum FreiburgFreiburgNémetországToboroz
Universitaetsklinikum Jena KöRJenaNémetországToboroz
Klinikum der Universität München-GroßhadernMünchenNémetországToboroz
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)MunichNémetországToboroz
Rostock University Medical CenterRostockNémetországToboroz
Universitaetsklinikum Tuebingen AöRTuebingenNémetországToboroz
Universitaetsklinikum Ulm AoRUlmNémetországToboroz
Hospital Clinic de BarcelonaBarcelonaSpanyolországToboroz
Hospital del MarBarcelonaSpanyolországToboroz
Hospital de la Santa Creu i Sant PauBarcelonaSpanyolországToboroz
Hospital Universitario DonostiaDonostiaSpanyolországToboroz
Institut Catala D'oncologiaL'Hospitalet de LlobregatSpanyolországToboroz
Hospital Universitario La PazMadridSpanyolországToboroz
Hospital Universitario Ramón y CajalMadridSpanyolországToboroz
Hospital Universitario HM SanchinarroMadridSpanyolországToboroz
Hospital Universitario 12 de OctubreMadridSpanyolországToboroz
Hospital Clínico San CarlosMadridSpanyolországToboroz
Hospital Universitario Virgen de la VictoriaMálagaSpanyolországToboroz
University Clinical Hospital Virgen De La ArrixacaMurciaSpanyolországToboroz
Hospital Universitario Central De AsturiasOviedoSpanyolországToboroz
Hospital Universitario De SalamancaSalamancaSpanyolországToboroz
Complexo Hospitalario Universitario De SantiagoSantiago de CompostelaSpanyolországToboroz
Hospital Universitario de ToledoToledoSpanyolországToboroz
Fundación Instituto Valenciano de OncologíaValenciaSpanyolországToboroz
Hospital Clínico Universitario de ValladolidValladolidSpanyolországToboroz
Mount Vernon HospitalBarnsleyEgyesült KirályságToboroz
AddenbrookesCambridgeEgyesült KirályságToboroz
Royal Devon University Hospital TrustExeterEgyesült KirályságToboroz
Royal Devon & Exeter HospitalExeterEgyesült KirályságToboroz
The Princess Alexandra HospitalHarlowEgyesült KirályságToboroz
The Royal Marsden HospitalLondonEgyesült KirályságToboroz
North Middlesex HospitalLondonEgyesült KirályságToboroz
University College London Hospitals NHS Foundation TrustLondonEgyesült KirályságToboroz
Barts Health NHS TrustLondonEgyesült KirályságToboroz
Royal Free HospitalLondonEgyesült KirályságToboroz
The James Cook University HospitalMiddlesbroughEgyesült KirályságToboroz
Churchill HospitalOxfordEgyesült KirályságToboroz
Derriford HospitalPlymouthEgyesült KirályságToboroz
Queen Alexandra HospitalPortsmouthEgyesült KirályságToboroz
Barking, Havering and Redbridge University Hospitals NHS trustRomfordEgyesült KirályságToboroz
North Tees Health NHS TrustStockton-on-TeesEgyesült KirályságToboroz
The Royal Marsden HospitalSuttonEgyesült KirályságToboroz
Kings Mill HospitalSutton in AshfieldEgyesült KirályságToboroz
Cork University HospitalCorkÍrországToborzás még nem indult
Saint Luke's Radiation Oncology NetworkDublinÍrországToborzás még nem indult
Tallaght University HospitalDublin 24ÍrországToborzás még nem indult
St Vincent's University HospitalDublin 4ÍrországToborzás még nem indult
Saint Luke's Radiation Oncology NetworkDublin 6ÍrországToborzás még nem indult
Mater Misericordiae University HospitalDublin 7ÍrországToborzás még nem indult
Beaumont HospitalDublin 9ÍrországToborzás még nem indult
UPMC Hillman Cancer Centre, UPMC Whitfield HospitalWaterfordÍrországToborzás még nem indult
Azienda Usl Della Valle D AostaAostaOlaszországToborzás még nem indult
Centro di Riferimento Oncologico di AvianoAvianoOlaszországToborzás még nem indult
Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaBresciaOlaszországToborzás még nem indult
IRCCS Azienda Ospedaliera MetropolitanaGenoaOlaszországToborzás még nem indult
Ospedale Vito Fazzi LecceLecceOlaszországToborzás még nem indult
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.lMeldolaOlaszországToborzás még nem indult
Istituto Europeo di Oncologia s.r.lMilanOlaszországToborzás még nem indult
Fondazione IRCCS - Istituto Nazionale dei TumoriMilanOlaszországToborzás még nem indult
Azienda Ospedaliera Universitaria Federico II Di NapoliNaplesOlaszországToborzás még nem indult
IRCCS Istituto Nazionale Tumori Fondazione PascaleNaplesOlaszországToborzás még nem indult
Istituto Oncologico VenetoPadovaOlaszországToborzás még nem indult
Azienda USL IRCCS di Reggio EmiliaReggio EmiliaOlaszországToborzás még nem indult
Fondazione Policlinico Universitario Agostino Gemelli IRCCSRomeOlaszországToborzás még nem indult
I.F.O. Istituti Fisioterapici OspitalieriRomeOlaszországToborzás még nem indult
Humanitas Mirasole S.p.A.RozzanoOlaszországToborzás még nem indult

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