Proton Radiation Therapy in Treating Patients With Prostate Cancer
A Phase II Trial of Proton Radiation Therapy of Using Standard Fractionation for Low-and Low-Intermediate Risk Adenocarcinoma of the Prostate
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This clinical trial is studying how well proton radiation therapy works in treating patients with prostate cancer.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Detailed Description
PRIMARY OBJECTIVES:
I. Feasibility of proton radiation therapy (RT) using standard fractionation.
SECONDARY OBJECTIVES:
I. To determine freedom from failure (FFF) (vs. biochemical/clinical progression-free survival) with standard fractionation.
II. To determine the incidence of grade 2 or greater GU and GI toxicity with this regimen at 6 months, 2 years and 3 years.
III. To assess quality of life issues following completion of radiation therapy at 6 months and at 2 years.
IV. To assess incidence of impotence after the use of proton therapy at 3 years.
V. To determine freedom from biochemical failure (BF) at 5 years.
VI. To determine clinical failure: local and/or distant at 5 years. VII. To determine salvage androgen deprivation (SAD) use at 5 years. VIII. To determine progression free survival: using clinical, biochemical and SAD as events at 5 years.
IX. To determine overall survival at 5 years. X. To determine disease-specific survival at 5 years.
XI. Estimate prostate and normal structures movement during RT with the use of scans.
XII. Correlate pathologic and radiologic findings with outcomes at 5 years. XIII. Correlate PSA and free PSA levels with outcomes at 5 years. XIV. Correlate testosterone levels and variation with proton therapy and outcomes at 5 years.
XV. Develop a quality assurance process for proton prostate therapy.
OUTLINE:
Patients undergo proton radiotherapy once daily 5 days a week for approximately 9 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 3 months, every 6 months for 5 years, and then annually thereafter.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19104
- Abramson Cancer Center of the University of Pennsylvania
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Histologically confirmed prostate adenocarcinoma within 365 days of registration
- Clinical stages T1a-T2a N0 M0
- For any pelvic lymph node >= 1.5cm, biopsy of the lymph node is mandatory
- Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason score must be in the range 2-6; > 6 cores is strongly recommended; the highest Gleason score in any core reported on the pathology report will be used for determining inclusion
- PSA values < 10 ng/ml within 90 days prior to registration, done either prior to prostate biopsy or at least 21 days after prostate biopsy.
- Alkaline phosphatase within 60 days prior to registration. If alkaline phosphatase is elevated > 2 x the upper limit of institutional normal (UNL), patient must have radiological correlation to assess for metastases
- Zubrod status 0-1 documented within 60 days of registration
- Prior androgen deprivation is allowed; however, androgen deprivation will not be continued concurrently or as an adjuvant therapy
- Patients must give IRB-approved study-specific informed consent
- Patients must complete all required tests listed within the specified time frames
- Patients must be able to start treatment within 56 days of registration
- Members of all races and ethnic groups are eligible for this trial
Exclusion Criteria:
- Clinical stages T2c or greater
- PSA of 10 ng/ml or greater
- Gleason score 7 or higher
- Evidence of distant metastasis
- Evidence of lymph node involvement
- Previous prostate cancer surgery to include: prostatectomy, hyperthermia and cryosurgery
- Previous pelvic radiation for prostate cancer
- Androgen deprivation therapy prior to radiation is allowed; however, it is not acceptable if continued during radiation or as adjuvant therapy
- Active rectal diverticulitis, Crohn's disease, or ulcerative colitis are not allowed
- Prior systemic chemotherapy for prostate cancer
- History of proximal urethral stricture requiring dilatation
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Arm I
Patients undergo proton radiotherapy once daily 5 days a week for approximately 9 weeks in the absence of disease progression or unacceptable toxicity.
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Proton Beam Radiation Therapy
Quality of Life Assessment
Questionnaire Administration
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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As a feasibility precaution patients will be treated and followed for a minimum of 60 days after completion of radiotherapy to determine feasibility
Délai: 5 years
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5 years
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Acute toxicity as assessed by NCI CTC Version 3.0
Délai: 90 days
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90 days
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Late toxicity as assessed by RTOG/EORTC late morbidity scoring system
Délai: 90 days
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90 days
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Biochemical/clinical progression-free survival
Délai: Time from start of radiotherapy to either documented increase in PSA or clinical progression of disease, death due to any cause or last patient contact alive
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Time from start of radiotherapy to either documented increase in PSA or clinical progression of disease, death due to any cause or last patient contact alive
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Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- UPCC 08809
- NCI-2009-01500
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