Strahlentherapie mit wissensbasierter RapidPlan-Planung vs. menschengesteuerter Planung zur Behandlung von Prostatakrebs
Randomisierte Phase-III-Studie zur wissensbasierten Rapid-Plan-Planung im Vergleich zur vom Menschen gesteuerten Planung für die Strahlentherapie bei Prostatakrebs
This phase III trial compares the effects of radiation therapy using RapidPlan, trademark, knowledge-based planning to human-driven planning in treating patients with prostate cancer. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Successful delivery of radiation requires planning to develop a treatment plan for how and where the radiation is to be delivered. RapidPlan is a knowledge-based treatment planning tool that automatically creates an optimal treatment plan based on identified targets and organs at risk for radiation exposure. Human-driven treatment planning by a dosimetrist, the current standard of care, requires significant resources and time and may vary within and among radiation centers. Giving radiation therapy with RapidPlan knowledge-based planning may have similar or less side effects compared to human-driven planning in treating patients with prostate cancer.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
- Verfahren: Biospecimen Collection
- Verfahren: Magnetic Resonance Imaging
- Sonstiges: Questionnaire Administration
- Verfahren: Positron Emission Tomography
- Strahlung: Photon Beam Radiation Therapy
- Strahlung: Radiation Therapy Treatment Planning and Simulation
- Strahlung: Radiation Therapy Treatment Planning and Simulation
Detaillierte Beschreibung
PRIMARY OBJECTIVE:
I. To determine if RapidPlan knowledge-based planning is non-inferior to human-driven planning regarding treatment-related rates of grade 3 or higher genitourinary (GU) and gastrointestinal (GI) adverse events at 3 months post-radiotherapy for prostate cancer.
EXPLORATORY OBJECTIVES:
I. After completion of radiation therapy, determine the incidence of:
Ia. Grade 2 or greater GU and GI toxicity at 3 months (Common Terminology Criteria for Adverse Events [CTCAE] version 5); Ib. Quality of life 3 months post-radiotherapy; Ic. Rate of achieving dose-volume constraints. II. Determine if there are any statistical differences in dose-volumes results with RapidPlan knowledge-based planning.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A (HUMAN-DRIVEN): Patients receive human-driven treatment planning and undergo radiation therapy over 15-30 minutes on 5-44 fractions per standard of care. Additionally, patients undergo magnetic resonance imaging (MRI) pre-treatment and blood sample collection and positron emission tomography (PET) throughout study.
ARM B (KNOWLEDGE-BASED): Patients receive RapidPlan treatment planning and undergo radiation therapy over 15-30 minutes on 5-44 fractions per standard of care. Additionally, patients undergo MRI pre-treatment and blood sample collection and PET throughout study.
After completion of study treatment, patients are followed up at 3 and 12 months then yearly for up to year 5.
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 3
Kontakte und Standorte
Studienkontakt
- Name: Clinical Trials Referral Office
- Telefonnummer: 855-776-0015
- E-Mail: mayocliniccancerstudies@mayo.edu
Studieren Sie die Kontaktsicherung
- Name: Cancer Clinical Trials Referral Office
- Telefonnummer: 507-293-6386
Studienorte
-
-
Arizona
-
Scottsdale, Arizona, Vereinigte Staaten, 85259
- Rekrutierung
- Mayo Clinic in Arizona
-
Kontakt:
- Clinical Trials Referral Office
- Telefonnummer: 855-776-0015
- E-Mail: mayocliniccancerstudies@mayo.edu
-
Hauptermittler:
- Nathan Y. Yu, MD
-
Kontakt:
- Cancer Clinical Trials Referral Office
- Telefonnummer: 507-293-6386
-
-
Florida
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Jacksonville, Florida, Vereinigte Staaten, 32224-9980
- Noch keine Rekrutierung
- Mayo Clinic in Florida
-
Kontakt:
- Clinical Trials Referral Office
- Telefonnummer: 855-776-0015
- E-Mail: mayocliniccancerstudies@mayo.edu
-
Kontakt:
- Cancer Clinical Trials Referral Office
- Telefonnummer: 507-293-6386
-
Hauptermittler:
- Homan Mohammadi, MD
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Patients must be at least 18 years old
- Histologically confirmed prostate cancer
- Clinical or pathologic stages T1c-T3b, Nx or N0-1, M0-1 (American Joint Committee on Cancer [AJCC] criteria 8th edition [Ed])
- Planned definitive dose radiotherapy to the prostate or prostate bed
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 assessed within 90 days of enrollment
- Patients must sign Institutional Review Board (IRB) approved study specific informed consent
- Patients must complete all required pre-entry tests within the specified time frames
- Patients must be able to start treatment (radiation) within 180 days of study registration
- In case of confusion about the eligibility or ineligibility of an individual patient, the principal investigator (PI) can be used as the arbiter and a note to file will be added to the subject's regulatory binder to document outcome
Exclusion Criteria:
- Previous pelvic radiation > 5 Gy
- Planned delivery of radiotherapy to pelvic lymph nodes
- Planned delivery of brachytherapy of the prostate
- Active rectal diverticulitis, Crohn's disease affecting the rectum, or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed)
- Prior hip replacement or penile implant
- Major medical, addictive, or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (consent by legal authorized representative is not permitted for this study)
- Indwelling or intermittent urinary catheter use
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: Arm A (human-driven treatment planning, radiation therapy)
Patients receive human-driven treatment planning and undergo radiation therapy over 15-30 minutes on 5-44 fractions per standard of care. Additionally, patients undergo MRI pre-treatment and blood sample collection and PET throughout study. |
Undergo blood sample collection
Andere Namen:
Undergo MRI
Andere Namen:
Ancillary studies Undergo PET
Andere Namen:
Undergo radiation therapy
Andere Namen:
Receive human-driven treatment planning
Andere Namen:
Receive RapidPlan treatment planning
Andere Namen:
|
|
Experimental: Arm B (RapidPlan treatment planning, radiation therapy)
Patients receive RapidPlan treatment planning and undergo radiation therapy over 15-30 minutes on 5-44 fractions per standard of care. Additionally, patients undergo MRI pre-treatment and blood sample collection and PET throughout study. |
Undergo blood sample collection
Andere Namen:
Undergo MRI
Andere Namen:
Ancillary studies Undergo PET
Andere Namen:
Undergo radiation therapy
Andere Namen:
Receive human-driven treatment planning
Andere Namen:
Receive RapidPlan treatment planning
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Incidence of grade 3 or higher genitourinary (GU) and gastrointestinal (GI) adverse events (AEs)
Zeitfenster: Up to 3 months post-radiotherapy
|
AEs will be defined using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Comparisons between treatment arms will be made using a non-inferiority test for the difference between two proportions with an alpha level of 5%. The proportion of patients experiencing grade 3 or higher GU or GI AEs over the number of patients eligible for toxicity will be estimated. |
Up to 3 months post-radiotherapy
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Nathan Y. Yu, MD, Mayo Clinic
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Urogenitale Erkrankungen
- Genitalerkrankungen
- Genitale Neubildungen, männlich
- Urogenitale Neoplasmen
- Neubildungen nach Standort
- Neubildungen
- Genitalerkrankungen, männlich
- Prostataerkrankungen
- Männliche Urogenitalerkrankungen
- Prostataneoplasmen
- Untersuchungstechniken
- Klinische Labortechniken
- Diagnosetechniken und Verfahren
- Diagnose
- Physikalische Phänomene
- Chemie -Techniken, analytisch
- Spektrumanalyse
- Elektromagnetische Phänomene
- Magnetische Phänomene
- Elektromagnetische Strahlung
- Elementarpartikel
- Licht
- Optische Phänomene
- Strahlung, nichtionisierend
- Strahlung
- Handhabung von Proben
- Magnetresonanzspektroskopie
- Photonen
Andere Studien-ID-Nummern
- GMROA2451
- GMROA2451 (Andere Kennung: Mayo Clinic Radiation Oncology)
- NCI-2024-07870 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))
- 24-006449 (Andere Kennung: Mayo Clinic Institutional Review Board)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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