Proton Beam or Intensity-Modulated Radiation Therapy in Treating Patients with Low or Low-Intermediate Risk Prostate Cancer

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Basic Trial Information

PhaseTypeStatusAgeTrial IDs
Phase IIIBiomarker/Laboratory analysis, Supportive care, TreatmentActive18 and over11-497
NCI-2012-01144, NCT01617161

Trial Description

Summary

This randomized phase III trial studies intensity-modulated radiation therapy (IMRT) or proton beam therapy (proton beam radiation therapy) (PBT) 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.

Further Study Information

PRIMARY OBJECTIVES:

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 disease-specific 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 8.5-9 weeks.

ARM II: Patients undergo PBT 5 days a week for 8.5-9 weeks.

After completion of study treatment, patients are followed up at 3, 6, 9, 12, 18, 24, 36, 48, and 60 months.

Eligibility Criteria

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 T2b

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

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 T2b) of prostate within 180 days of study entry

Exclusion Criteria:

Prior surgery (not including 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

Hip prosthesis, 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 they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals diagnosed and treated for non-metastatic basal cell or squamous cell carcinoma of the skin are eligible

Individuals who are known to have acquired immunodeficiency syndrome (AIDS) (cluster of differentiation [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

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Dana-Farber Harvard Cancer Center

  • National Cancer Institute
Jason Alexander Efstathiou, Principal Investigator

Trial Sites

U.S.A.

Massachusetts
Charlestown

Massachusetts General Hospital

Jason Alexander Efstathiou
Ph: 617-726-5866
Email: jefstathiou@partners.org

Jason Alexander Efstathiou
Principal Investigator

See All Trial Sites

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01617161

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.