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Intensity Modulated Radiation Therapy for Prostate Cancer

17 juli 2019 bijgewerkt door: Kevin Camphausen, M.D., National Cancer Institute (NCI)

A Pilot Study of Image Guided Prostate and Pelvic Nodal Irradiation With Intensity Modulated Radiation Therapy (IMRT) in Prostate Cancer

BACKGROUND:

-This study represents a progression from findings in four previous National Cancer Institute (NCI) Radiation Oncology Branch (ROB) protocols (02-C-0167A, 02-C-0207E, 03-C-0190B, 04-C-0171). In these previous works we have begun to develop techniques to obtain Magnetic Resonance (MR) biological images and co-register tissue in prostate cancer patients.

OBJECTIVES:

-The primary objective of the first portion of this study is to assess the feasibility of using Intensity-modulated radiation therapy (IMRT) to treat the at-risk lymph nodes in prostate cancer. Also, if feasible, we hope optimize this technique with experience.

ELIGIBILITY:

-This is a study of image guided, targeted radiation therapy in patients with high risk of nodal metastases from prostate cancer. Patients with prostate cancer who have more than 15% risk of lymph node (as defined by the Partin tables) metastasis will be eligible for this study.

DESIGN:

  • On the first 10 patients, we will perform approximately 5 computed tomography (CT) simulations throughout the course of their therapy. On each simulation, the initial treatment plan will be re-run. The dose-volume data from target and normal tissues will then be re-analyzed. From this analysis we will be better able to determine the size of margins needed to account for organ motion and changes such as varying amounts of gas in the bowel and fluid in the bladder. To the best of our knowledge, no such analyses have been published.
  • If the initial part of this trial is feasible, we will proceed to a phase I dose escalation trial of radiation to the at-risk lymph nodes. The primary statistical objective of the phase I portion of this study is to estimate the Maximum Tolerated Dose (MTD) of external beam radiation based on evaluating acute toxicity. The study will be conducted with a dose-escalation design with 3 patients in each dose cohort. If fewer than 2 of 3 patients experience an acute dose limiting toxicity (DLT) than patients will be accrued to the next dose cohort. If 2 or more of 3 patients experience a DLT then the MTD will be exceeded and the prior, lower dose cohort will be considered the MTD. Secondary objectives of this study are to relate patterns in gene and protein expression to response and toxicity and to evaluate the frequency of late term toxicity.
  • Specific procedures and risks will be described in a separate consent to be obtained at the time of biopsy. Tissue samples will be processed for complementary deoxyribonucleic acid (cDNA) microarray testing and stored for future analysis in the Radiation Oncology Branch, NCI.
  • Anatomic Magnetic Resonance Imaging (MRI) and magnetic resonance (MR) biological images of the prostate and pelvis will be obtained and tissue will be acquired with biopsy locations precisely translated (co-registered) to an MR image of reference. A fiducial marker (gold seed) will be left at the biopsy site as a fiducial marker to direct future radiation therapy to the prostate. If necessary, additional fiducial markers will be placed for prostate localization during treatment.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

BACKGROUND:

-This study represents a progression from findings in four previous National Cancer Institute (NCI) Radiation Oncology Branch (ROB) protocols (02-C-0167A, 02-C-0207E, 03-C-0190B, 04-C-0171). In these previous works we have begun to develop techniques to obtain Magnetic Resonance (MR) biological images and co-register tissue in prostate cancer patients.

OBJECTIVES:

-The primary objective of the first portion of this study is to assess the feasibility of using Intensity-modulated radiation therapy (IMRT) to treat the at-risk lymph nodes in prostate cancer. Also, if feasible, we hope optimize this technique with experience.

ELIGIBILITY:

  • This is a study of image guided, targeted radiation therapy in patients with high risk of nodal metastases from prostate cancer.
  • Patients with prostate cancer who have more than 15% risk of lymph node (as defined by the Partin tables) metastasis will be eligible for this study.

DESIGN:

  • On the first 10 patients, we will perform approximately 5 computed tomography (CT) simulations throughout the course of their therapy. On each simulation, the initial treatment plan will be re-run. The dose-volume data from target and normal tissues will then be re-analyzed. From this analysis we will be better able to determine the size of margins needed to account for organ motion and changes such as varying amounts of gas in the bowel and fluid in the bladder. To the best of our knowledge, no such analyses have been published.
  • If the initial part of this trial is feasible, we will proceed to a phase I dose escalation trial of radiation to the at-risk lymph nodes. The primary statistical objective of the phase I portion of this study is to estimate the Maximum Tolerated Dose (MTD) of external beam radiation based on evaluating acute toxicity. The study will be conducted with a dose-escalation design with 3 patients in each dose cohort. If fewer than 2 of 3 patients experience an acute dose limiting toxicity (DLT) than patients will be accrued to the next dose cohort. If 2 or more of 3 patients experience a DLT then the MTD will be exceeded and the prior, lower dose cohort will be considered the MTD. Secondary objectives of this study are to relate patterns in gene and protein expression to response and toxicity and to evaluate the frequency of late term toxicity.
  • Specific procedures and risks will be described in a separate consent to be obtained at the time of biopsy. Tissue samples will be processed for complementary deoxyribonucleic acid (cDNA) microarray testing and stored for future analysis in the Radiation Oncology Branch, NCI.
  • Anatomic Magnetic Resonance Imaging (MRI) and magnetic resonance (MR) biological images of the prostate and pelvis will be obtained and tissue will be acquired with biopsy locations precisely translated (co-registered) to an MR image of reference. A fiducial marker (gold seed) will be left at the biopsy site as a fiducial marker to direct future radiation therapy to the prostate. If necessary, additional fiducial markers will be placed for prostate localization during treatment.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

19

Fase

  • Vroege fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Maryland
      • Bethesda, Maryland, Verenigde Staten, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 90 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Mannelijk

Beschrijving

  • INCLUSION CRITERIA:

Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

Pathology report confirming adenocarcinoma of the prostate

Risk of lymph node metastasis greater than or equal to15% as defined by the Partin tables or biopsy proven positive lymph nodes

Tumor visible on magnetic resonance imaging (MRI)

No prior surgery, radiation, or chemotherapy for prostate cancer, with the exception of hormone therapy which may be given neoadjuvantly for up to four (4) months.

Age greater than 18 years old and less than 90 years old.

EXCLUSION CRITERIA:

Cognitively impaired patients who cannot give informed consent.

Patients with metastatic disease beyond the pelvis

Contraindication to biopsy

  • Bleeding disorder
  • Prothrombin time (PT)/partial thromboplastin time (PTT) greater than or equal to 1.5 times the upper limit of normal
  • Platelets less than or equal to 50K
  • Artificial heart valve

Contraindication to MRI

  • Patients weighing greater than136 kgs (weight limit for the scanner tables)
  • Allergy to magnetic resonance (MR) contrast agent
  • Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices.

Pre-existing and active prostatitis or proctitis

Other medical conditions deemed by the principal investigator (PI) or associates to make the patient ineligible for protocol investigations, procedures, and high-dose external beam radiotherapy.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Arm 1- 5040cGy to the lymph nodes
5040Gray (cGy) to the lymph nodes
Straling: Radiation
Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.
Experimenteel: Arm 2 - 5400cGy to the lymph nodes
5400Gray (cGy) to the lymph nodes
Straling: Radiation
Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.
Experimenteel: Arm 3 - 5900cGy to the lymph nodes
5900Gray (cGy) to the lymph nodes
Straling: Radiation
Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants With Any Grade 2 Toxicity Using Intensity Modulated Radiation Therapy (IMRT) to Treat the At-risk Lymph Nodes in Prostate Cancer ( up to First 10 Patients)
Tijdsspanne: At one week, one month, 2 months, 3 months, 6 months, 9 months, 1 year, 18 months, 2 years, 30 months, and 3 years after radiation therapy
Radiation side effects were assessed by the Radiation Oncology Group (RTOG) Acute/Late Toxicity Grading Gastrointestinal and Genitourinary criteria. Acute Grade 0 - no symptoms, Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life threatening, and Grade 5 is death directly related to radiation side effects. Late toxicity is defined as occurring after 90 days.
At one week, one month, 2 months, 3 months, 6 months, 9 months, 1 year, 18 months, 2 years, 30 months, and 3 years after radiation therapy
Maximum Tolerated Dose (MTD) of External Beam Radiation to Pelvic Lymph Nodes of Interest in Patients Receiving Radiation Therapy for Prostate Cancer (After the First 10 Patients) In Arm 1, Arm 2, and Arm 3
Tijdsspanne: Completion of Treatment, an average of 8.5 weeks
Maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 or more in a cohort of either 3 or 6 patients experiences a dose limiting toxicity (DLT) attributed to radiation therapy. An acute DLT will be defined as Radiation Therapy Oncology Group (RTOG) grade 3 or greater, acute gastrointestinal or genitourinary toxicity within 3 months after the completion of radiation.
Completion of Treatment, an average of 8.5 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants With Grade 2 Late Gastrointestinal or Genitourinary Toxicity Assessed by the Radiation Oncology Group (RTOG) Criteria
Tijdsspanne: At median follow-up, approximately 28 months following radiation
Long-term effects and toxicity following intensity modulated radiation therapy (IMRT) dose escalation to the pelvic nodes were measured by the Radiation Oncology Group (RTOG) Criteria. Lower GI/Pelvis grade 2 toxicity Diarrhea requiring parasympatholytic drugs (e.g. Lomotil)/mucous discharge not necessitating sanitary pads/rectal or abdominal pain requiring analgesics and Genitourinary grade 2 defined as Frequency of urination or nocturia that is less frequent than every hour. Dysuria, urgency, bladder spasm requiring local anesthetic (e.g. Pyridium).
At median follow-up, approximately 28 months following radiation
Number of Participants With a Dose Limiting Toxicity (DLT)
Tijdsspanne: Within 3 months after completion of radiation
An acute Dose Limiting Toxicity (DLT) will be defined as Radiation Therapy Oncology Group (RTOG) grade 3 or greater, acute gastrointestinal or genitourinary toxicity within 3 months after the completion of radiation.
Within 3 months after completion of radiation
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
Tijdsspanne: Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
Number of Participants With Grade 3 or 4 Acute and/or Late Gastrointestinal or Genitourinary Toxicity Assessed by the Radiation Oncology Group (RTOG) Criteria
Tijdsspanne: At median follow-up, approximately 28 months following radiation
Long-term effects and toxicity following intensity modulated radiation therapy (IMRT) dose escalation to the pelvic nodes were measured by the Radiation Oncology Group (RTOG) Criteria. Grade 3 toxicity Lower GI/Pelvis is Diarrhea requiring parenteral support/severe mucous or blood discharge necessitating sanitary pads/abdominal distention (flat plate radiograph demonstrates distended bowel loops), Grade 3 toxicity Genitourinary Frequency with urgency and nocturia hourly or more frequently/dysuria, pelvis pain or bladder spasm requiring regular, frequent narcotic/gross hematuria with/without clot passage.
At median follow-up, approximately 28 months following radiation

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

National Cancer Institute (NCI)

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

19 september 2005

Primaire voltooiing (Werkelijk)

27 mei 2014

Studie voltooiing (Werkelijk)

18 april 2018

Studieregistratiedata

Eerst ingediend

19 juni 2006

Eerst ingediend dat voldeed aan de QC-criteria

20 september 2005

Eerst geplaatst (Schatting)

21 september 2005

Updates van studierecords

Laatste update geplaatst (Werkelijk)

19 juli 2019

Laatste update ingediend die voldeed aan QC-criteria

17 juli 2019

Laatst geverifieerd

1 juli 2019

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 050241
  • 05-C-0241

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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