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Prostate CancerPhase 1NCT02572284

Dose Escalation Study of Preoperative SBRT for High Risk Prostate Cancer

A Phase 1 study testing Stereotactic Body Radiation Therapy (SBRT), Prostatectomy and Quality of Life Questionnaires in people with Prostate Cancer, run by H. Lee Moffitt Cancer Center and Research Institute 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
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Trial summary

The purpose of this study is to compare the effects, good and/or bad, of different doses of SBRT given before prostatectomy. Depending when participants enter the study, they will be treated with either 5 or 6 gray (Gy) per day of radiation. A Gy is a measure of radiation dose. 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?
Stereotactic Body Radiation Therapy (SBRT), Prostatectomy and Quality of Life Questionnaires
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteUnited States
Study dates
27 Jan 2016to 23 Oct 2019
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

  • Histologically-proven prostate adenocarcinoma.
  • Clinical stage ≤T3a based on digital rectal exam and/or ≤T3a based on MRI (if done); N0-Nx; M0-Mx (AJCC 7th Edition)
  • Prostate-specific antigen (PSA) ≤ 80 ng/ml, obtained within 3 months.
  • Patients belonging in the National Comprehensive Cancer Network (NCCN) high recurrence risk group. High risk: Clinical stage T3a, or Gleason score = 8-10, or PSA >20 ng/mL.
  • Prostate volume: ≤ 80 cc on transrectal ultrasound
  • IPSS score ≤15
Show all 17Show fewer
  • Zubrod performance status 0-2 or equivalent
  • No prior total prostatectomy or cryotherapy of the prostate. Prior transurethral resection or laser ablation is permitted.
  • No prior radiotherapy to the prostate or lower pelvis
  • No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion
  • No history of an invasive malignancy (other than this prostate cancer, or non-metastatic basal or squamous skin cancers) in the last 5 years
  • No androgen deprivation therapy (ADT) can be prescribed prior to or during radiation therapy
  • Must be able to have gold fiducial markers placed in the prostate or, if patient already has fiducial markers placed, they must be in accordance with the protocol specifications
  • Ability to understand and the willingness to sign a written informed consent document
  • Willingness to fill out IPSS, SHIM, and EPIC quality of life forms
  • Age ≥18 years
  • IPSS (AUA) score ≤15

Who cannot join

  • Does not have a diagnosis of prostate adenocarcinoma
  • Has very low risk, low risk, intermediate risk or very high risk disease as defined by the NCCN
  • Has stage N1 or M1 (metastatic) disease
  • Has a PSA of greater than 80 ng/ml obtained no greater than 3 months prior to randomization
  • Prostate volume greater than 80 cc on transrectal ultrasound
  • Zubrod performance status 3 or greater
Show all 15Show fewer
  • Prior total prostatectomy or cryotherapy of the prostate
  • Prior radiation therapy to the pelvis
  • Implanted hardware which limits treatment planning or delivery (determined by the investigator).
  • Diagnosis of an invasive malignancy within 5 years (other than current prostate cancer or non-metastatic basal or squamous skin cancers)
  • The use of androgen deprivation therapy (ADT) prior to registration or during radiation
  • Inability to have gold fiducial markers placed in the prostate, or fiducial markers already placed, that are not in accordance with the protocol
  • Unwilling or inability to give informed consent
  • Not willing to fill out IPSS, SHIM, and EPIC quality of life questionnaires
  • IPSS score >15

Trial locations and contacts

1 site in 1 country.

United States1 site

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Phase I Dose Escalation Study of Preoperative Stereotactic Body Radiation Therapy (SBRT) for High Risk Prostate Cancer

The purpose of this study is to compare the effects, good and/or bad, of different doses of SBRT given before prostatectomy. Depending when participants enter the study, they will be treated with either 5 or 6 gray (Gy) per day of radiation. A Gy is a measure of radiation dose. The standard dose is 10Gy per day when SBRT is the only treatment to the prostate and no surgery is planned. The researchers want to see which dose of radiation will work best with the least amount of side effects. About 4-6 weeks after SBRT, participants will have a prostatectomy.

Conditions
Prostate Cancer
Being tested
Stereotactic Body Radiation Therapy (SBRT), Prostatectomy, Quality of Life Questionnaires
Keywords
Stereotactic Body Radiation Therapy (SBRT), High Risk Prostate Cancer, Preoperative SBRT, Prostate Adenocarcinoma, Prostatectomy, Quality of Life
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Stereotactic Body Radiation Therapy (SBRT)Radiation

    Also called radiation therapy

    The first group of patients to enter the study will receive 5 Gy of SBRT per day for 5 days, the second group will receive 6 Gy per day for 5 days. Each treatment will take about 3 minutes and be given as an outpatient at Moffitt Cancer Center.

  • ProstatectomyProcedure or surgery

    Also called surgery

    About 4-6 weeks after SBRT, participants will have a prostatectomy.

  • Quality of Life QuestionnairesOther

    Also called questionnaire

    Patient assessed health-related quality of life (HRQOL). Quality of Life (QOL) will be assessed using Prostate Symptom Score (IPSS), rectal assessment scale (RAS), sexual health inventory for men (SHIM), and Expanded Prostate Cancer Index Composite (EPIC) patient questionnaires: administered prior to SBRT, and at 2 weeks, 4 weeks, 2 months and then every 3 months up to 18 months post-prostatectomy.

Study groups in NCT02572284
Study groupRoleWhat they receive
Dose Escalation of SBRTExperimentalStereotactic Body Radiation Therapy (SBRT) followed by prostatectomy and Quality of Life questionnaires. The radiation will be given for only 5 days. Conventional radiation to the prostate is given over 7-8 weeks.
Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT); Procedure: Prostatectomy; Other: Quality of Life Questionnaires

What is being measured

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

  1. Dose Limiting Toxicity

    Acute dose-limiting toxicity and quality of life due to preoperative SBRT followed by robotic-assisted laparoscopic radical prostatectomy at 14 ± 5 days and 28 ± 5 days post-prostatectomy in high risk prostate cancer patients. In order to assess the toxicity of preoperative SBRT, the severity of specific events will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 form where a score of ≥3 is considered dose-limiting.

    Measured: Up to 28 ± 5 days post-prostatectomy

Secondary outcomes (8)

  1. Occurrence of Late Toxicity

    Late (defined as occurring more than 90 days after the start of radiotherapy) toxicity that is grade 2 or more as defined by the Common Terminology Criteria for Adverse Events version 4.

    Measured: 90+ days after start of radiotherapy

  2. Mean Catheterization Time for Study Participants

    Mean catheterization time for study participants, compared to existing mean statistics for robotic-assisted laparoscopic radical prostatectomy.

    Measured: Up to 18 months post surgery

  3. Mean Hospital Stay for Study Participants

    Mean hospital stay for study participants, compared to existing mean statistics for robotic-assisted laparoscopic radical prostatectomy.

    Measured: Up to 18 months post surgery

  4. Reoperation Rate for Study Participants

    Mean reoperation rate for study participants, compared to existing mean statistics for robotic-assisted laparoscopic radical prostatectomy.

    Measured: Up to 18 months post surgery

  5. Patient-Assessed Changes in Health-Related Quality of Life (HRQOL) - Expanded Prostate Cancer Index Composite (EPIC)

    Administered prior to SBRT, and at 2 weeks, 4 weeks, 2 months and then every 3 months up to 18 months post-prostatectomy. The 26-item, short-form version of the Expanded Prostate Cancer Index Composite (EPIC) is a validated questionnaire used to assess HRQOL in prostate cancer patients. EPIC includes 4 domains: urinary, bowel, sexual, and hormonal. There are summary, i.e., overall, scores and function and bother subscale scores for each of the 4 domains. The urinary domain has 2 additional subscales: incontinence and irritative/obstructive. Domains and subscales are scored using a 0-100 grading system, with a higher score indicating a better quality of life.

    Measured: Up to 18 months post surgery

  6. Patient-Assessed Changes in HRQOL - International Prostate Symptom Score (IPSS)

    Administered prior to SBRT, and at 2 weeks, 4 weeks, 2 months and then every 3 months up to 18 months post-prostatectomy. The IPSS will be used to assess changes in urinary toxicity. Scoring is 0, 1, 2, 3, 4, 5 per question, Total IPSS Score out of 35 points from 7 questions. Descriptive summaries of scores at baseline and each subsequent follow up will include means and standard deviations.

    Measured: Up to 18 months post surgery

  7. Patient-Assessed Changes in HRQOL - Rectal Assessment Scale (RAS)

    Administered prior to SBRT, and at 2 weeks, 4 weeks, 2 months and then every 3 months up to 18 months post-prostatectomy. The RAS will be used to assess changes in rectal toxicity. Scoring is 0, 1, 2, 3 per question, Total RAS Score out of 15 points from 5 questions. Descriptive summaries of scores at baseline and each subsequent follow up will include means and standard deviations.

    Measured: Up to 18 months post surgery

  8. Patient-Assessed Changes in HRQOL - Sexual Health Inventory for Men (SHIM)

    Administered prior to SBRT, and at 2 weeks, 4 weeks, 2 months and then every 3 months up to 18 months post-prostatectomy. The SHIM will be used to assess changes in sexual toxicity. Scoring is 0, 1, 2, 3, 4, 5 per question, Total SHIM score out of 25 points from 5 questions. Descriptive summaries of scores at baseline and each subsequent follow up will include means and standard deviations.

    Measured: Up to 18 months post surgery

Timeline

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

  1. First posted8 Oct 2015 (estimated)
  2. Study start27 Jan 2016
  3. Primary completion5 Jul 2018
  4. Study completion23 Oct 2019

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02572284
Sponsor's protocol ID
MCC-18201
Status last verified
Jan 2023
First submitted
7 Oct 2015
Last updated
19 Jan 2023
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Stereotactic Body Radiation Therapy (SBRT), Prostatectomy and Quality of Life Questionnaires in people with Prostate Cancer, run by H. Lee Moffitt Cancer Center and Research Institute 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 17 inclusion and 15 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 19 Jan 2023. 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?

Dose Limiting Toxicity (time frame: Up to 28 ± 5 days post-prostatectomy). 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 NCT02572284.

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 19 Jan 2023.

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