Prostate CancerNCT03748719
Single Arm Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade Group 4 Prostate Cancer
A study testing Stereotactic Body Radiation Therapy (SBRT) in people with Prostate Cancer, run by H. Lee Moffitt Cancer Center and Research Institute.
Trial summary
This study involves Stereotactic Body Radiation Therapy (SBRT) followed by prostatectomy (removal of the prostate). SBRT is a relatively new radiation technique in which a few doses of radiation are delivered to small, well-defined tumors. It has been used effectively in other cancers like lung and liver. 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)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 19 Nov 2018to 4 Dec 2019
- Phase
- Interventional
- 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
- Histologically proven prostate adenocarcinoma.
- Clinical stage ≤T3a based on digital rectal exam (DRE) and ≤T3a based on MRI (within 3 months); N0-Nx; M0-Mx, or Gleason score 4 + 4. No more than 1 lymph node >1 cm.
- PSA ≤ 50 ng/ml, obtained within 3 months
- Prostate volume: ≤60 cc.
- IPSS score ≤15.
- No previous radiotherapy to the prostate or lower pelvis.
- Lymph node risk of <35% using https://www.mskcc.org/nomograms/prostate/pre_op.
- No prior radical prostatectomy or cryotherapy of the prostate (prior transurethral resection or laser ablation are permitted).
- 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 3 years.
- No androgen deprivation therapy (ADT) can be prescribed prior to or during radiation therapy.
- Participant must be able to have gold fiducial markers placed in the prostate. Note: patients can be enrolled after fiducial markers have been placed, as long as the procedure was done in accordance with the protocol (Section 4.2.2).
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Ability to understand and the willingness to sign a written informed consent document.
- Willing to fill out quality of life questionnaires.
About this study
Official title: A Single Arm Phase II Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade Group 4 Prostate Cancer
This study involves Stereotactic Body Radiation Therapy (SBRT) followed by prostatectomy (removal of the prostate). SBRT is a relatively new radiation technique in which a few doses of radiation are delivered to small, well-defined tumors. It has been used effectively in other cancers like lung and liver. The radiation will be given for only 5 days.
The purpose of this study is to compare the effects, good and/or bad, of different doses of SBRT given before prostatectomy.
- Conditions
- Prostate Cancer
- Being tested
- Stereotactic Body Radiation Therapy (SBRT)
- Keywords
- High Risk Prostate Cancer, prostate, radiation therapy
- 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)Device
SBRT treatment
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Body Radiation Therapy, followed by Prostatectomy | Experimental | Patients will receive 6 Gy per day of Stereotactic Body Radiation Therapy (SBRT) per day for 5 days, followed by prostatectomy in 3 weeks. Receives: Device: Stereotactic Body Radiation Therapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of PSA (Prostate Specific Antigen)
Measure of PSA through treatment. PSA is expected to be undetectable (<0.2 mg/ml) after prostatectomy and radiation therapy.
Measured: Up to 12 months
Number of symptomatic adverse anastomotic events
Number of symptomatic anastomotic events related to pre-operative SBRT.
Measured: Up to 12 months
Secondary outcomes (3)
Mean Catheterization Time
Average time of catheterization following prostatectomy
Measured: Up to 4 weeks post surgery
Mean Hospital Stay
Average time of hospitalization after prostatectomy
Measured: Up to 2 week post surgery
Quality of Life assessment
Quality of Life will be assessed using 2 questionnaires: International Prostate Symptom Score (IPSS) and Sexual Health Inventory for Men (SHIM). The IPSS is an eight question questionnaire of symptoms ranging from 0 "not at all" to 5 "always". The SHIM is a five question questionnaire ranging from 1 "almost never or never" to 5 "almost always or always" to determine erectile dysfunction.
Measured: Baseline, at 2 weeks, 4 weeks, 2 months and every 3 months up to 12 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start19 Nov 2018
- Primary completion15 Oct 2019
- Study completion4 Dec 2019
Why it stopped: No accrual interest
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Johnstone, MD, Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03748719
- Sponsor's protocol ID
- MCC-19670
- Status last verified
- May 2020
- First submitted
- 19 Nov 2018
- Last updated
- 22 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Phase II Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade Group 4 Prostate Cancer
- ClinicalTrials.gov ID
- NCT03748719
- Acronym / sponsor ID
- MCC-19670
- Conditions
- Prostate Cancer
- Keywords
- High Risk Prostate Cancer, prostate, radiation therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No accrual interest
- Enrolment
- 0 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 4 Dec 2019 (actual)
- First posted
- 21 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study involves Stereotactic Body Radiation Therapy (SBRT) followed by prostatectomy (removal of the prostate). SBRT is a relatively new radiation technique in which a few doses of radiation are delivered to small, well-defined tumors. It has been used effectively in other cancers like lung and liver. The radiation will be given for only 5 days.
The purpose of this study is to compare the effects, good and/or bad, of different doses of SBRT given before prostatectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Body Radiation Therapy, followed by Prostatectomy | Experimental | Device: Stereotactic Body Radiation Therapy (SBRT)Patients will receive 6 Gy per day of Stereotactic Body Radiation Therapy (SBRT) per day for 5 days, followed by prostatectomy in 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT)SBRT treatment | Device | Stereotactic Body Radiation Therapy, followed by Prostatectomy |
Primary outcome
Measure of PSA (Prostate Specific Antigen)
Time frame: Up to 12 months
Measure of PSA through treatment. PSA is expected to be undetectable (<0.2 mg/ml) after prostatectomy and radiation therapy.
Number of symptomatic adverse anastomotic events
Time frame: Up to 12 months
Number of symptomatic anastomotic events related to pre-operative SBRT.
3 secondary outcomes
Mean Catheterization Time
Time frame: Up to 4 weeks post surgery
Mean Hospital Stay
Time frame: Up to 2 week post surgery
Quality of Life assessment
Time frame: Baseline, at 2 weeks, 4 weeks, 2 months and every 3 months up to 12 months post surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2020.
- Moffitt Cancer Center Clinical Trials WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Johnstone, MD principal investigator
H. Lee Moffitt Cancer Center and Research Institute
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Body Radiation Therapy (SBRT) in people with Prostate Cancer, run by H. Lee Moffitt Cancer Center and Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 22 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Measure of PSA (Prostate Specific Antigen) (time frame: Up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2020.