Proton Beam or Intensity-Modulated Radiation Therapy in Treating Patients with Low or Intermediate Risk Prostate Cancer
This phase III trial studies intensity-modulated radiation therapy (IMRT) or proton beam therapy (proton beam radiation therapy) (PBT) and how well the work in treating patients with prostate cancer. Radiation therapy uses high energy x-rays or protons to kill tumor cells and shrink tumors. It is not yet known whether IMRT or PBT is more effective in treating patients with prostate cancer.
Inclusion Criteria
- Males diagnosed with histologically confirmed, adenocarcinoma of the prostate based on core biopsy prior to study entry from transrectal ultrasonography (TRUS)
- American Joint Committee on Cancer (AJCC) 7th edition clinical stages T1c to T2c
- Prostate specific antigen (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, obtained at biopsy, =< 6, 3 + 4 = 7, or 4 + 3 = 7
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 as documented within 3 months prior to study entry
- Age >= 18 years
- Participants must have a complete history and physical examination within 45 days of study entry * Participants must have a digital rectal examination (confirming clinical stage T1c to T2c) of prostate within 180 days of study entry
Exclusion Criteria
- Prior surgery (not including transurethral prostatic resection [TURP]), cryosurgery, radiofrequency ablation, chemotherapy or radiation for PCa
- Prior or planned androgen deprivation or bilateral orchiectomy
- Individuals with distant metastases or clinically or pathologically involved lymph nodes are ineligible; if suspected, they must be ruled out by computed tomography (CT), pelvic magnetic resonance imaging (MRI), or bone scan within 365 days of study entry
- Bilateral hip prostheses, inflammatory bowel disease or connective tissue disorder such as active scleroderma or lupus (radiotherapy contraindications)
- 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 are known to have acquired immunodeficiency syndrome (AIDS) (CD 4 < 200 or an AIDS-defining illness) or are known to be human immunodeficiency virus (HIV) positive and not on highly active antiretroviral therapy (HAART) are ineligible
- Individuals with major medical or psychiatric illness which would prevent the completion of study treatment and/or interfere with follow up are excluded from this study
- 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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01617161.
PRIMARY OBJECTIVE:
I. Compare the reduction in mean Expanded Prostate Cancer Index Composite (EPIC) bowel scores for men with low or intermediate risk prostate cancer (PCa) treated with PBT versus IMRT at 24 months following radiation (where higher scores represent better outcomes).
SECONDARY OBJECTIVES:
I. Assess the effectiveness of PBT versus IMRT for men with low or intermediate risk PCa in terms of disease-specific quality of life as measured by patient-reported outcomes, perceptions of care and adverse events.
II. Assess the cost-effectiveness of PBT versus IMRT under current conditions and model future cost-effectiveness for alternative treatment delivery and cost scenarios.
III. Develop predictive models to examine the associations between selected metrics of individual radiation dose distributions (including both the planned and delivered doses estimated based on serial imaging) and patient reported bowel, urinary, and erectile function.
IV. Identify and evaluate biomarkers of prostate cancer behavior and response to radiotherapy.
V. Assess longer-term rates of biochemical failure-free survival, metastasis-free survival, progression-free survival, cancer-specific survival, and overall survival as well as development of late effects such as second cancers.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo IMRT 5 days a week for 9 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study.
ARM II: Patients undergo PBT 5 days a week for 9 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 3, 6, 9, 12, 18, 24, 36, 48, and 60 months. Patients enrolled at Massachusetts General Hospital (MGH) or MGH satellites may optionally participate in extended follow-up beyond 60 months.
Trial PhasePhase III
Trial Typetreatment
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorJason Alexander Efstathiou
- Primary ID11-497
- Secondary IDsNCI-2012-01144
- ClinicalTrials.gov IDNCT01617161