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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


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Biochemical disease-free survival

Outcome Description:

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.

Outcome Time Frame:

5-8 years

Safety Issue:

No

Principal Investigator

Charles Leonard, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rocky Mountain Cancer Centers

Authority:

United States: Institutional Review Board

Study ID:

511-03

NCT ID:

NCT01409473

Start Date:

August 2011

Completion Date:

August 2022

Related Keywords:

  • Prostate Cancer
  • 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
  • Prostatic Neoplasms

Name

Location

Rocky Mountain Cancer Centers - AuroraAurora, Colorado  80012
Rocky Mountain Cancer Centers - LittletonLittleton, Colorado  80120