Stereotactic Body Radiotherapy (SBRT) With Concurrent Boost for Low- and Intermediate-Risk Prostate Cancer (Prostate SBRT)

A Prospective Protocol of Stereotactic Body Irradiation With Concurrent Intraprostatic Lesion Boost Utilizing Intensity Modulated Radiotherapy for Patients With Low- and Intermediate-Risk Prostate Cancer

The purpose of this study is to determine whether stereotactic body radiation therapy (SBRT) with simultaneous boost (higher radiation dose) to areas within the prostate with more prominent cancerous growth (intraprostatic lesions) utilizing intensity modulated radiotherapy (IMRT) planning techniques is a safe and effective treatment in patients with low- and intermediate-risk localized prostate cancer.

Study Overview

• Status: Withdrawn
• Conditions: Prostate Cancer
• Intervention / Treatment: Radiation: Prostate SBRT with concurrent boost to intraprostatic lesion(s)

Detailed Description

Standard external beam radiation therapy (EBRT) for low- to intermediate-risk prostate cancer involves several weeks of daily treatment sessions. Stereotactic body radiation therapy (SBRT) is a newer form of EBRT that gives fewer treatments but higher doses of radiation per treatment. In many patients there are certain areas within the prostate with more prominent cancerous growth (intraprostatic lesions), which may require higher doses of radiation (boost) to treat effectively. This study will treat the prostate with simultaneous boost(s) to intraprostatic lesion(s) in 5 treatments over 10-14 days.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Rocky Mountain Cancer Centers - Aurora
    • Littleton, Colorado, United States, 80120
      • Rocky Mountain Cancer Centers - Littleton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Histologically proven diagnosis of prostate adenocarcinoma within one year
• Gleason Score 2-7
• Clinical T-stage T1b-T2c (AJCC 7th Edition)
• Clinical Nx or N0, and Mx or M0
• PSA < 20 ng/mL
• Low or intermediate risk according to NCCN guidelines: Low: Clinical Stage (CS) T1b-T2a and Gleason 2-6 and PSA < 10 ng/ml; Intermediate: CS T2b-T2c and Gleason 2-6 and PSA < 10 ng/ml, or CS T1b-T2a and Gleason 7 and PSA < 10 ng/ml, or CS T1b-T2a and Gleason 2-6 and PSA 10-20ng/mL
• ECOG performance status 0 or 1
• Has had a pre-treatment PSA drawn within a month of the beginning of protocol therapy
• If androgen-deprivation therapy (ADT) has been initiated, must have a documented pre-ADT PSA; this baseline PSA should not be obtained during following periods: 1) 10-day period following prostate biopsy; 2) within 30 days after discontinuation of finasteride; or 3) within 90 days after discontinuation of dutasteride.
• Has completed a baseline health-related quality of life assessment Extended Prostate Cancer Index Composite questionnaire (EPIC-26)
• Has had a history and physical examination (including digital rectal examination and a formal morbidity assessment via the ACE-27) within 60 days
• Morbidity score (via the ACE-27) of none (0), mild (1) or moderate (2)
• Willing and able to use adequate contraception during protocol treatment and for 3 months after the completion of protocol treatment

Exclusion Criteria:

• Invasive (carcinoma in situ is allowed) solid or hematologic malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years
• Prior prostatectomy or cryotherapy of the prostate
• Prior radiotherapy to the prostate or lower pelvis
• Prior or concurrent cytotoxic chemotherapy for prostate cancer (prior chemotherapy for a different cancer is allowed)
• Implanted hardware near the planning target volume that would prohibit appropriate treatment planning or treatment delivery in the investigator's opinion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prostate SBRT; Prostate SBRT with concurrent boost to intraprostatic lesion (IPL) will be delivered in 5 fractions using intensity-modulated radiotherapy planning techniques.	Radiation: Prostate SBRT with concurrent boost to intraprostatic lesion(s); 40 Gy in 5 fractions to prostate for low-risk and 45 Gy in 5 fractions to prostate for intermediate-risk patients, and 50 Gy in 5 fractions to intraprostatic lesion(s), delivered over 10-14 days on preferably every other day.; Other Names: Stereotactic surgery to the prostate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemical disease-free survival	Biochemical Disease-Free Survival (bDFS), the time from completion of protocol treatment to the documented PSA rise of 2 ng/mL above the PSA nadir reached after treatment.	5-8 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grade 2 or higher acute gastrointestinal, genitourinary, and erectile toxicities	Grade 2 or higher acute gastrointestinal, genitourinary, and erectile toxicities, graded per CTCAE 3.0. Acute adverse events will be recorded as the first occurrence of worst severity of the adverse event ≤ 30 days from completion of protocol radiotherapy.	30 days from completion of protocol radiotherapy
Grade 3 or higher late gastrointestinal, genitourinary, and erectile toxicities	Grade 3 or higher late gastrointestinal, genitourinary, and erectile toxicities, graded per CTCAE 3.0. Late adverse events are defined as the first occurrence of a late grade 3+ adverse event > 30 days from completion of protocol radiotherapy.	>30 days to 5 years from completion of protocol radiotherapy
Freedom from failure	Freedom from failure, defined as the time from the first date of radiation to first event of biochemical failure (nadir + 2 ng/mL), local recurrence, regional recurrence, or distant disease as defined below.	5-8 years
Local recurrence-free survival	Local recurrence-free survival, defined as the time from the first date of radiation to first pathologic confirmation of in-prostate tumor recurrence. The local recurrence will be dated when the palpable progression was first identified. In the event of biochemical failure followed by negative metastatic workup and positive biopsy for in-prostate recurrence, the local recurrence will be dated the date of the documented biochemical failure.	5-8 years
Distant disease-free survival	Distant disease-free survival, defined as the time from the first date of radiation to first documentation of metastatic disease by any method, regardless of the occurrence of any intervening local or regional failure or non-prostate second primary cancer. If metastatic diagnosis was prompted by biochemical failure, distant recurrence will be dated the date of biochemical failure.	5-8 years
Cause-specific survival	A death will be deemed a prostate cancer specific death if death is due to prostate cancer or a complication from treatment.	5-8 years
Overall survival	Overall survival, defined as the time from the first date of radiation to death due to any cause.	8-10 years
Health-related quality of life	Health-related quality of life (HRQOL), measured with the Extended Prostate Cancer Index Composite questionnaire - short form (EPIC-26).	2-3 years

Collaborators and Investigators

• Sponsor: Rocky Mountain Cancer Centers
• Collaborators: Dr. Dennis Carter
• Investigators: Principal Investigator: Charles Leonard, MD, Rocky Mountain Cancer Centers

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Anticipated): August 1, 2018
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: August 3, 2011
• First Submitted That Met QC Criteria: August 3, 2011
• First Posted (Estimate): August 4, 2011

Study Record Updates

• Last Update Posted (Estimate): February 12, 2014
• Last Update Submitted That Met QC Criteria: February 10, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Prostate cancer; IMRT; SBRT; IPL; Radiosurgery; Stereotactic body radiotherapy; Intensity-modulated radiotherapy; Early-stage prostate cancer; Low-risk prostate cancer; Intermediate-risk prostate cancer; Intraprostatic lesions
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 511-03; WIRB #20111125 (Other Identifier: Western IRB)