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Prostate CancerPhase 2Prostate SBRTNCT01409473

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

A Phase 2 study testing Prostate SBRT with concurrent boost to intraprostatic lesion(s) in people with Prostate Cancer, run by Rocky Mountain Cancer Centers at 2 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Prostate SBRT with concurrent boost to intraprostatic lesion(s)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
2 sitesUnited States
Study dates
Aug 2011to Aug 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Rocky Mountain Cancer Centers - Aurora

    Aurora, Colorado, 80012

  • Rocky Mountain Cancer Centers - Littleton

    Littleton, Colorado, 80120

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Prostate Cancer
Being tested
Prostate SBRT with concurrent boost to intraprostatic lesion(s)
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
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prostate SBRT with concurrent boost to intraprostatic lesion(s)Radiation

    Also called Stereotactic surgery to the prostate

    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.

Study groups in NCT01409473
Study groupRoleWhat they receive
Prostate SBRTExperimentalProstate SBRT with concurrent boost to intraprostatic lesion (IPL) will be delivered in 5 fractions using intensity-modulated radiotherapy planning techniques.
Receives: Radiation: Prostate SBRT with concurrent boost to intraprostatic lesion(s)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 5-8 years

Secondary outcomes (8)

  1. 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.

    Measured: 30 days from completion of protocol radiotherapy

  2. 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.

    Measured: >30 days to 5 years from completion of protocol radiotherapy

  3. 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.

    Measured: 5-8 years

  4. 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.

    Measured: 5-8 years

  5. 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.

    Measured: 5-8 years

  6. 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.

    Measured: 5-8 years

  7. Overall survival

    Overall survival, defined as the time from the first date of radiation to death due to any cause.

    Measured: 8-10 years

  8. Health-related quality of life

    Health-related quality of life (HRQOL), measured with the Extended Prostate Cancer Index Composite questionnaire - short form (EPIC-26).

    Measured: 2-3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionAug 2018 (estimated)
  4. Study completionAug 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01409473
Sponsor's protocol ID
511-03
Other IDs
WIRB #20111125
Acronym
Prostate SBRT
Status last verified
Feb 2014
First submitted
3 Aug 2011
Last updated
12 Feb 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Prostate SBRT with concurrent boost to intraprostatic lesion(s) in people with Prostate Cancer, run by Rocky Mountain Cancer Centers at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 12 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biochemical disease-free survival (time frame: 5-8 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01409473.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2014.

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