NCT01617161Fut, nem toboroz
Proton Therapy vs. IMRT for Low or Intermediate Risk Prostate Cancer
Prostate Advanced Radiation Technologies Investigating Quality of Life (PARTIQoL): A Phase III Randomized Clinical Trial of Proton Therapy vs IMRT for Low or Intermediate Risk Prostate Cancer
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 11.
Rövid összefoglaló (regiszter, angolul)
We are studying whether men being treated for prostate cancer have the same amount of side effects from either one of two different external radiation treatments: IMRT or PBT. With IMRT, a number of x-ray beams are used to shape the radiation to the prostate. PBT is another type of external radiation treatment for prostate cancer that is used in a few centers in the United States. Protons are tiny particles with positive charge that can be controlled to travel a certain distance and stop. PBT is precise like IMRT, but it uses proton beams instead of x-ray beams. IMRT and PBT aim to deliver most of the radiation to the prostate cancer while sparing surrounding tissues. Both IMRT and PBT have been used in the treatment of prostate cancer and are thought to be equally effective at curing prostate cancer. However, both treatments have also been shown to cause the potential side effects of radiation, including bowel, urinary and erectile problems. It is possible that side effect rates with PBT will be lower, the same, or even higher than with IMRT, but this has not been studied well to date. Though both of these radiation therapies have been used in the past to treat prostate cancer, there has never been a study that compares the effects of these two therapies to see which one has less side effects. In this research study, we are comparing IMRT to PBT to determine which therapy best minimizes the side effects of treatment.
- Állapot (regiszter)
- Fut, nem toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 454 (tényleges)
- Első benyújtás
- 2012. jún. 8.
- Kezdés
- 2012. júl. 25.
- Elsődleges befejezés
- 2025. dec.
- Fő szponzor
- Massachusetts General Hospital
- Betegségek
- Prosztatarák
- NCT-szám
- NCT01617161
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 454
- 2012. júl. 25. és az elsődleges befejezés (2025. dec.) között
- 13 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- Prior surgery (not including TURP), cryosurgery, radiofrequency ablation, chemotherapy or radiation for PCa
- Prior or planned androgen deprivation or bilateral orchiectomy
Más betegség
- Hip prosthesis, inflammatory bowel disease or connective tissue disorder such as active scleroderma or lupus
- Individuals with a history of other malignancies are ineligible unless 1) they have been disease-free for at least 5 years OR 2) are deemed by the investigator to be at low risk for recurrence of that malignancy with no plans for adjuvant systemic chemotherapy and/or radiation therapy and have received overall principal investigator approval.
- Individuals who have AIDS (CD4 < 200 or an AIDS-defining illness) or are HIV positive and not on HAART therapy are ineligible.
- Major medical or psychiatric illness
- Individuals with any of the following conditions are excluded from this study:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months.
- Transmural myocardial infarction within the last 6 months.
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- History of Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects within the last 12 months
Egyéb
- Distant metastases, or clinically or pathologically involved lymph nodes confirmed by a CT scan within 365 days of study entry
Kiket keres a vizsgálat
- Diagnosed with histologically confirmed adenocarcinoma of the prostate based on core-biopsy within 1 year of study entry from TRUS
- Clinical stages T1c to T2c
- PSA <20, within 6 months of study entry
- Participants who are currently receiving Dutasteride (or have received it within the last 90 days) or Finasteride (or have received it within the last 30 days) must have a PSA of ≤ 10
- Gleason score ≤6, 3 + 4 = 7, or 4 + 3 = 7
- ECOG Performance Status 0-1 as documented within 3 months prior to study entry
- Must have complete history and physical examination within 45 days of study entry and digital rectal examination of prostate within 180 days of study entry
Életkor a regiszterben: 18 év – - · Nem: csak férfiak · Egészséges önkénteseket nem fogad
Helyszínek (13)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Massachusetts General Hospital | Boston | Egyesült Államok | Ismeretlen állapot |
| Northwestern Medicine Chicago Proton Center | Chicago | Egyesült Államok | Ismeretlen állapot |
| University Hospital of Cleveland | Cleveland | Egyesült Államok | Ismeretlen állapot |
| University of Maryland Medical Center | College Park | Egyesült Államok | Ismeretlen állapot |
| Mass General/North Shore Cancer Center | Danvers | Egyesült Államok | Ismeretlen állapot |
| University of Florida Health Proton Therapy Institute | Jacksonville | Egyesült Államok | Ismeretlen állapot |
| Provision Proton Therapy Center | Knoxville | Egyesült Államok | Ismeretlen állapot |
| Rutgers Cancer Institute of New Jersey | New Brunswick | Egyesült Államok | Ismeretlen állapot |
| Hospital of the University of Pennsylvania | Philadelphia | Egyesült Államok | Ismeretlen állapot |
| Mayo Clinic | Rochester | Egyesült Államok | Ismeretlen állapot |
| University of Washington Medical Center | Seattle | Egyesült Államok | Ismeretlen állapot |
| Princeton ProCure Proton Therapy Center | Somerset | Egyesült Államok | Ismeretlen állapot |
| Washington University | St Louis | Egyesült Államok | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.