- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01041326
Preoperative Radiation Therapy for High Risk Prostate Cancer
16 juli 2013 uppdaterad av: Duke University
A Phase I Dose-Escalation Study of Preoperative Radiation Therapy Followed by Radical Prostatectomy in Patients With High Risk, Localized Carcinoma of the Prostate
This is a Phase I dose-escalation study of moderate dose radiation therapy prior to radical prostatectomy for patients with high-risk localized disease.
Its hypothesis is that such treatment will be well tolerated with similar side effect profile as surgery alone.
Patients in Groups 1 and 2 will receive 39.6 Gy and 45 Gy (at 1.8 Gy/fx), respectively, to the whole pelvis.
Patients in Groups 3 and 4 will receive 45 Gy to the whole pelvis, followed by a boost to the prostate and periprostatic tissue, for total doses of 50.4 and 54 Gy, respectively.
The patient will then undergo radical prostatectomy between 4-8 weeks after completion of radiation.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
15
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
North Carolina
-
Durham, North Carolina, Förenta staterna, 27710
- Duke University Medical Center
-
-
Virginia
-
Richmond, Virginia, Förenta staterna, 23298
- Virginia Commonwealth University
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 70 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Manlig
Beskrivning
Inclusion Criteria:
Subjects must have
- biopsy-confirmed "high-risk" prostate cancer, defined as A. PSA > 20, B. Gleason Score (GS) >/= 8, and/or C. Clinical stage T3 disease per AJCC Staging Manual, 6th edition; or D. At least two out of three of the following: PSA 10-19.9, GS = 7, or clinical stage = T2b / T2c.
- a negative bone scan,
- be medically fit to undergo surgery as determined by treating urologist,
- age > 18,
- KPS must be >/= 80,
- no prior pelvic radiation therapy, chemotherapy, or androgen deprivation,
- no prior invasive malignancy, except non- melanomatous skin cancer unless disease free for a minimum of 5 years. Carcinoma in-situ of the bladder or head and neck region is permissible.
- Subjects must freely sign informed consent to enroll in the study.
Exclusion Criteria:
- prior pelvic radiation therapy, chemotherapy, or androgen deprivation,
- prior invasive malignancy, except non- melanomatous skin cancer, carcinoma in-situ of the bladder or head and neck region, unless disease free for a minimum of 5 years.
- Metastatic disease as demonstrated by bone scan, CT scan or MRI of the pelvis, or chest x-ray.
- Pathologically documented positive pelvic lymph nodes. If Pre-operative CT scan or MRI (ordered at the discretion of the treating physicians) demonstrates lymph nodes which are suspicious for involvement, then biopsy must be undertaken and nodes proven negative before patient can enroll on this trial.
- Declared high-risk for anesthesia by attending anesthesiologist, cardiologist, or other physician.
- History of prior pelvic radiation therapy.
- History of androgen deprivation therapy or chemotherapy.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Leve 1 Radiation
Subjects in Group 1 will receive 39.6 Gy (at 1.8 Gy/fx) to the whole pelvis.
The subject will then undergo radical prostatectomy between 4-8 weeks after completion of radiation.
|
Pre-operative Radiation to Prostate, SV, and Pelvic Lymph Nodes
Patients will undergo evaluation by a surgeon for consideration of resection after completion of radiation therapy.
If a surgical resection is possible, it is recommended that patients undergo surgery four to eight weeks after completion of radiation therapy.
This surgical procedure will be performed by one of the standard accepted approaches.
|
Experimentell: Level 2 Radiation
Subjects in Group 2 will receive 45 Gy (at 1.8 Gy/fx) to the whole pelvis.
The subject will then undergo radical prostatectomy between 4-8 weeks after completion of radiation.
|
Pre-operative Radiation to Prostate, SV, and Pelvic Lymph Nodes
Patients will undergo evaluation by a surgeon for consideration of resection after completion of radiation therapy.
If a surgical resection is possible, it is recommended that patients undergo surgery four to eight weeks after completion of radiation therapy.
This surgical procedure will be performed by one of the standard accepted approaches.
|
Experimentell: Level 3 Radiation
Subjects in Group 3 will receive 45 Gy to the whole pelvis, followed by a boost to the prostate and periprostatic tissue, for total doses of 50.4 Gy.
The subject will then undergo radical prostatectomy between 4-8 weeks after completion of radiation.
|
Pre-operative Radiation to Prostate, SV, and Pelvic Lymph Nodes
Patients will undergo evaluation by a surgeon for consideration of resection after completion of radiation therapy.
If a surgical resection is possible, it is recommended that patients undergo surgery four to eight weeks after completion of radiation therapy.
This surgical procedure will be performed by one of the standard accepted approaches.
|
Experimentell: Level 4 Radiation
Subjects in Group 4 will receive 45 Gy to the whole pelvis, followed by a boost to the prostate and periprostatic tissue, for total doses of 54 Gy.
The subject will then undergo radical prostatectomy between 4-8 weeks after completion of radiation.
|
Pre-operative Radiation to Prostate, SV, and Pelvic Lymph Nodes
Patients will undergo evaluation by a surgeon for consideration of resection after completion of radiation therapy.
If a surgical resection is possible, it is recommended that patients undergo surgery four to eight weeks after completion of radiation therapy.
This surgical procedure will be performed by one of the standard accepted approaches.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
post-operative morbidity
Tidsram: 30 day
|
30 day
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
continence
Tidsram: 1 year
|
1 year
|
erectile function
Tidsram: 1 year
|
1 year
|
biochemical recurrence
Tidsram: 2 years
|
2 years
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Bridget F Koontz, MD, Duke University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2005
Primärt slutförande (Faktisk)
1 april 2013
Avslutad studie (Faktisk)
1 april 2013
Studieregistreringsdatum
Först inskickad
30 december 2009
Först inskickad som uppfyllde QC-kriterierna
30 december 2009
Första postat (Uppskatta)
31 december 2009
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
17 juli 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 juli 2013
Senast verifierad
1 juli 2013
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Pro00006510
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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