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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Dr. Dennis Carter
Information provided by (Responsible Party):
Rocky Mountain Cancer Centers
ClinicalTrials.gov Identifier:
NCT01409473
First received: August 3, 2011
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Radiation: Prostate SBRT with concurrent boost to intraprostatic lesion(s)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Rocky Mountain Cancer Centers:

Primary Outcome Measures:
  • Biochemical disease-free survival [ Time Frame: 5-8 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Grade 2 or higher acute gastrointestinal, genitourinary, and erectile toxicities [ Time Frame: 30 days from completion of protocol radiotherapy ] [ Designated as safety issue: Yes ]
    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.

  • Grade 3 or higher late gastrointestinal, genitourinary, and erectile toxicities [ Time Frame: >30 days to 5 years from completion of protocol radiotherapy ] [ Designated as safety issue: Yes ]
    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.

  • Freedom from failure [ Time Frame: 5-8 years ] [ Designated as safety issue: No ]
    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.

  • Local recurrence-free survival [ Time Frame: 5-8 years ] [ Designated as safety issue: No ]
    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.

  • Distant disease-free survival [ Time Frame: 5-8 years ] [ Designated as safety issue: No ]
    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.

  • Cause-specific survival [ Time Frame: 5-8 years ] [ Designated as safety issue: No ]
    A death will be deemed a prostate cancer specific death if death is due to prostate cancer or a complication from treatment.

  • Overall survival [ Time Frame: 8-10 years ] [ Designated as safety issue: No ]
    Overall survival, defined as the time from the first date of radiation to death due to any cause.

  • Health-related quality of life [ Time Frame: 2-3 years ] [ Designated as safety issue: No ]
    Health-related quality of life (HRQOL), measured with the Extended Prostate Cancer Index Composite questionnaire - short form (EPIC-26).


Enrollment: 0
Study Start Date: August 2011
Estimated Study Completion Date: August 2022
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Stereotactic surgery to the prostate

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01409473

Locations
United States, Colorado
Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado, United States, 80012
Rocky Mountain Cancer Centers - Littleton
Littleton, Colorado, United States, 80120
Sponsors and Collaborators
Rocky Mountain Cancer Centers
Dr. Dennis Carter
Investigators
Principal Investigator: Charles Leonard, MD Rocky Mountain Cancer Centers
  More Information

No publications provided

Responsible Party: Rocky Mountain Cancer Centers
ClinicalTrials.gov Identifier: NCT01409473     History of Changes
Other Study ID Numbers: 511-03, WIRB #20111125
Study First Received: August 3, 2011
Last Updated: February 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Rocky Mountain Cancer Centers:
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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on August 21, 2014