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

NCT01409473 | Withdrawn Phase 2

• 2 other identifiers: 511-03WIRB #20111125
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Prostate cancer; Stereotactic body radiotherapy; Radiosurgery; Intensity-modulated radiotherapy; SBRT; IMRT; Early-stage prostate cancer; Low-risk prostate cancer; Intermediate-risk prostate cancer; Intraprostatic lesions; IPL

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Grade 2 or higher acute gastrointestinal, genitourinary, and erectile toxicities

  30 days from completion of protocol radiotherapy

• Grade 3 or higher late gastrointestinal, genitourinary, and erectile toxicities

  >30 days to 5 years from completion of protocol radiotherapy

• Freedom from failure

  5-8 years

• Local recurrence-free survival

  5-8 years

• Distant disease-free survival

  5-8 years

Study Arms (1)

Prostate SBRT

EXPERIMENTAL

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)

Interventions

Prostate SBRT with concurrent boost to intraprostatic lesion(s) RADIATION

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.

Also known as: Stereotactic surgery to the prostate

Prostate SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rocky Mountain Cancer Centers: lead
• Dr. Dennis Carter: collaborator

Study Sites (2)

Rocky Mountain Cancer Centers - Aurora

Aurora, Colorado, 80012, United States

Location

Rocky Mountain Cancer Centers - Littleton

Littleton, Colorado, 80120, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Charles Leonard, MD

  Rocky Mountain Cancer Centers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2011
• First Posted: August 4, 2011
• Study Start: August 1, 2011
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2022
• Last Updated: February 12, 2014

Record last verified: 2014-02

Locations

US (2)