AzTrials
AzTrials

AdenocarcinomaPhase 1NCT02653248

SBRT for Organ Confined Prostate Cancer

A Phase 1 study testing Stereotactic Body Radiation Therapy in people with Adenocarcinoma and Prostate Cancer, run by Northwell Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Stereotactic Body Radiation Therapy (SBRT) is a method of delivering radiation which can target the tumor more precisely and cause less damage to normal tissue. This is a Phase I research study looking at the safety of the dose of SBRT in organ confined prostate cancer. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Adenocarcinoma, Prostate Cancer
What is being tested?
Stereotactic Body Radiation Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
Aug 2010to Dec 2021
Phase
Phase 1
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

  • Willing and capable to provide informed consent
  • Signed study specific informed consent
  • Prostate specific-antigen (PSA) ≤ 10 Gleason 2-7
  • Appropriate staging studies identifying as American Joint Committee on Cancer (AJCC) stage T1a, T1b, T1c, T2a, T2b
  • No direct evidence of regional or distant metastases after appropriate staging studies
  • Histologic confirmation of cancer by biopsy
Show all 9Show fewer
  • Age ≥ 18
  • Karnofsky Performance Status must be ≥ 70
  • American Urological Association (AUA) score must be ≤ 15 (alpha blockers allowed)

Who cannot join

  • Female
  • Positive lymph nodes of metastatic disease from prostate cancer
  • Prior invasive malignancy unless disease free for a minimum of 3 years (carcinoma in situ of the breast, oral cavity, or non-melanomatous skin cancer are all permissable)
  • T2c, T3, or T4 tumors
  • Previous pelvic radiotherapy
  • Previous surgery or chemotherapy for prostate cancer
Show all 20Show fewer
  • Previous transurethral resection of the prostate (TURP) or cryotherapy to the prostate
  • Concomitant hormonal therapy
  • Concomitant antineoplastic therapy (including surgery, cryotherapy, conventionally fractionated radiotherapy, and chemotherapy) while on this protocol
  • History of Crohn's Disease or Ulcerative Colitis
  • Previous significant obstructive symptoms; AUA score must be ≤ 15 (alpha blockers allowed)
  • Significant psychiatric illness
  • Severe, active co-morbidity defined as follows:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months.
  • Transmural myocardial infarction within the last 6 months
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  • Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
  • Acquired Immune Deficiency Syndrome (AIDS) based upon current Center Disease Control and Prevention (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.
  • History of treatment with potent immunosuppressive drugs for such conditions as post organ transplant, severe rheumatoid arthritis, etc. within the past 6 months.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • North Shore-LIJ Cancer Institute

    Lake Success, New York, 11042

Other trials in United States

About this study

Official title: Phase I Study of Stereotactic Body Radiation Therapy (SBRT) for Organ Confined Prostate Cancer

Stereotactic Body Radiation Therapy (SBRT) is a method of delivering radiation which can target the tumor more precisely and cause less damage to normal tissue. This is a Phase I research study looking at the safety of the dose of SBRT in organ confined prostate cancer.

Read the detailed description

Radiation options for treating early stage prostate cancer can include external radiation therapy, which is radiation given outside the body, or prostate seed implant, which is placing radioactive seeds directly into the prostate. For external beam radiation therapy, treatment can last up to 9 weeks. Treatment is given daily, Monday through Friday. This may not be the most convenient option for some patients.

One way to potentially overcome this challenge is to deliver a more intense dose of radiation treatment to the tumor over a shorter amount of time. Stereotactic Body Radiation Therapy (SBRT) is a technique that treats the prostate with fewer treatments and can decrease the effect of radiation to the surrounding tissues. This study is a Phase I research study, which means that it will look at the safety of the dose of the SBRT. While SBRT itself is a standard of care method to administer radiation therapy, there has not been a specific dose outlined in the past. The aim of this study is to determine the dose that will treat the prostate cancer but cause the least amount of side effects.

Medical subject headings
Adenocarcinoma, Prostatic Neoplasms

What participants receive

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

  • Stereotactic Body Radiation TherapyRadiation

    Also called SBRT

    Patients will receive 5 fractions of SBRT radiation, treated every other day. No more than three fractions per week. Total dose will depend on cohort. Cohort 1: 40Gy, Cohort 2: 45 Gy, Cohort 3: 50 Gy.

Study groups in NCT02653248
Study groupRoleWhat they receive
Cohort 1ExperimentalPatients will receive 5 fractions of Stereotactic Body Radiation Therapy (SBRT). Dose per fraction is 8Gy. Total Dose: 40Gy. To escalate the dose of stereotactic radiotherapy to a tumoricidal dose without exceeding the maximum tolerated dose in patients with organ confined prostate cancer.
Receives: Radiation: Stereotactic Body Radiation Therapy
Cohort 2ExperimentalPatients will receive 5 fractions of Stereotactic Body Radiation Therapy (SBRT). Dose per fraction is 9Gy. Total Dose: 45 Gy. To escalate the dose of stereotactic radiotherapy to a tumoricidal dose without exceeding the maximum tolerated dose in patients with organ confined prostate cancer.
Receives: Radiation: Stereotactic Body Radiation Therapy
Cohort 3ExperimentalPatients will receive 5 fractions of Stereotactic Body Radiation Therapy (SBRT). Dose per fraction is 10Gy. Total Dose: 50Gy. To escalate the dose of stereotactic radiotherapy to a tumoricidal dose without exceeding the maximum tolerated dose in patients with organ confined prostate cancer.
Receives: Radiation: Stereotactic Body Radiation Therapy

What is being measured

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

  1. Maximum tolerated dose

    Patients in each dose cohort will all be treated as a single dose group for dose escalation. Each cohort will have 7-15 patients. The study will be completed when either of the following events occur: 1- The Maximum Tolerated Dose (MTD) for a cohort is reached or 2- when the highest protocol dose level is treated and tolerated (10 Gy/fraction, total 50 Gy) where we consider the therapy likely to be tumoricidal per determination of the investigators. Follow up assessments will be: 1.5 months post treatment, 3, 6, 9, and 12 months post treatment, then every 6 months until five years post treatment, then annually for years 5-10. A period of 90 days must pass in order to assess toxicity. If 90 days have transpired without Dose Limiting Toxicity (DLT) in each of the first seven patients enrolled to a specific dose level, then dose escalation to the next level may proceed.

    Measured: Up to 10 years

Secondary outcomes (8)

  1. Measurement of response - No Evidence of Disease

    No clinical evidence of disease on digital rectal examination.

    Measured: Up to 10 years

  2. Measurement of response - Equivocal Disease

    1. If abnormalities are present on the prostate digital rectal examination but are thought to be abnormal due to treatment and felt not to represent tumor.
    2. If clinical evidence of residual tumor is present but this has regressed from a previous examination.

    Measured: Up to 10 years

  3. Measurement of response - Radiographic Evidence of Disease

    1. Radiographic evidence of hematogenous (osseous, hepatic, etc.) and/or extrapelvic lymphatic of soft tissue relapse.
    2. Radiographic evidence of tumor recurrence within the pelvic lymphatics or soft tissue beneath the bifurcation of the common iliac arteries.

    Measured: Up to 10 years

  4. Time to Biochemical failure

    Prostate Specific Antigen (PSA) levels should be obtained per study calendar. The RTOG-ASTRO definition (also known as the Phoenix definition) of PSA failure will be used. Thus, when the PSA rises by more than 2 ng/ml above the lowest level (nadir) achieved after treatment, biochemical failure has occurred and the date of the failure is recorded at the time the nadir plus 2 ng/ml level is reached.

    Measured: Up to 10 years

  5. Disease-Free Interval

    The disease-free interval will be measured from the date of accession to the date of documentation of progression or until the date of death (from other causes).

    Measured: Up to 10 years

  6. Time to Distant Failure

    The time to distant failure will be measured from the date of study entry to the date of documented regional nodal recurrence or distant disease relapse. Patients with evidence of biochemical failure, but a negative prostate biopsy, will be considered as distant failure only.

    Measured: Up to 10 years

  7. Overall Survival

    The survival time will be measured from the date of accession to the date of death. All patients will be followed for survival. Every effort should be made to document the cause of death

    Measured: Up to 10 years

  8. Disease-Specific Survival

    Disease-specific survival will be measured from the date of study entry to the date of death due to prostate cancer. The following will be considered as failure events in assessing disease specific survival.

    Measured: Up to 10 years

Timeline

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

  1. First posted12 Jan 2016 (estimated)
  2. Study startAug 2010
  3. Primary completionJun 2018
  4. Study completionDec 2021

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02653248
Sponsor's protocol ID
10-128B
Status last verified
Feb 2022
First submitted
26 Aug 2015
Last updated
9 Feb 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • Potters L, Rana Z, Lee L, Cox BW. Outcomes of a Dose-Escalated Stereotactic Body Radiation Phase 1 Trial for Patients With Low- and Intermediate-Risk Prostate Cancer. Int J Radiat Oncol Biol Phys. 2019 Jun 1;104(2):334-342. doi: 10.1016/j.ijrobp.2019.01.092. Epub 2019 Feb 2.

    PubMed 30721721

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Stereotactic Body Radiation Therapy in people with Adenocarcinoma and Prostate Cancer, run by Northwell Health at 1 site 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 9 inclusion and 20 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: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Maximum tolerated dose (time frame: Up to 10 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 NCT02653248, which also lists 1 linked publication.

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 9 Feb 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in