Prostate CancerPhase 1NCT02946008
Neoadjuvant Stereotactic Body Radiotherapy Prior to Radical Prostatectomy for High Risk Prostate Cancer
A Phase 1 study testing Stereotactic Body Radiation Therapy and Radical Prostatectomy in people with Prostate Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
This is a single-arm prospective non-randomized, non-blinded trial to assess the safety of neoadjuvant stereotactic body radiation therapy (SBRT) before surgery in high risk prostate cancer patients. Radiation therapy will be delivered over 5 treatment sessions for approximately 1.5 weeks total. 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 and Radical Prostatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2017to 12 Jul 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
- Subjects must have biopsy-confirmed adenocarcinoma of the prostate.
- Subjects must have a negative bone scan.
- Subjects must have one of the following risk factors:
- PSA ≥20 and/or
- Gleason score ≥8 and/or
- Clinical or radiographic stage ≥T3a per AJCC (American Joint Committee on Cancer) 7th Edition Staging Manual and/or
Show all 15Show fewer
- Radiographic pelvic lymph node positive disease and/or
- At least two out of four of the following: PSA (Prostate Specific Antigen) 10-19.9, GS (Gleason Score) = 3+4, clinical stage = T2b/T2c, ≥50% positive biopsy cores.
- Subjects must freely sign informed consent to enroll in the study.
- Subjects must be medically fit to undergo surgery determined by the PI.
- Age ≥ 18
- KPS Karnofsky Performance Status (performance status is an attempt to quantify cancer patients' general well-being and activities of daily life, scores range from 0 to 100 where 100 represents perfect health and 0 represents death): ≥70.
- No prior invasive malignancy in the past 3-years, except non-melanomatous skin cancer unless disease free for a minimum of 2 years. Carcinoma in-situ of the bladder or head and neck region is permissible.
- Subjects must not have had prior pelvic radiation therapy,
- Subjects must not have had prior androgen deprivation therapy in the past 6 months.
Who cannot join
- Metastatic disease as demonstrated by bone scan, CT scan or MRI (Magnetic Resonance Imaging) of the pelvis, or chest x-ray.
- Declared high-risk for anesthesia by attending anesthesiologist, cardiologist, or other physician.
- History of prior pelvic radiation therapy.
- History of androgen deprivation therapy within the past 6 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
About this study
Official title: A Phase I Trial of Neoadjuvant Stereotactic Body Radiotherapy Prior to Radical Prostatectomy for High Risk Prostate Cancer
This is a single-arm prospective non-randomized, non-blinded trial to assess the safety of neoadjuvant stereotactic body radiation therapy (SBRT) before surgery in high risk prostate cancer patients.
Radiation therapy will be delivered over 5 treatment sessions for approximately 1.5 weeks total.
- Conditions
- Prostate Cancer
- Being tested
- Stereotactic Body Radiation Therapy, Radical Prostatectomy
- 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 TherapyRadiation
Delivered over 5 treatment sessions for approximately 1.5 weeks total.
Radical ProstatectomyProcedure or surgery
Open, laparoscopic, or robotic radical prostatectomy and pelvic lymph node dissection to remove the prostate, seminal vesicles, and pelvic lymph nodes.
| Study group | Role | What they receive |
|---|---|---|
| SBRT | Experimental | Stereotactic Body Radiation Therapy (SBRT) will be delivered over 5 treatment sessions for approximately 1.5 weeks total. Receives: Radiation: Stereotactic Body Radiation Therapy; Procedure: Radical Prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Neoadjuvant SBRT
The MTD is defined as the SBRT dose that with radical prostatectomy induces dose-limiting toxicity in 28% of subjects or less.
Measured: 6-week post-prostatectomy
Secondary outcomes (6)
Incidence of Urinary Incontinence
Urinary incontinence will be scored according to Common Toxicity Criteria for Adverse Events (CTCAE) v.4.0 (Grade 1 = Occasional, Grade 2 = Spontaneous, pads indicated, Grade 3 = Intervention indicated)
Measured: up to one year post treatment
Incidence of Urinary Stricture
Urinary stricture, according to Common Toxicity Criteria for Adverse Events (CTCAE) v.4.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening, Grade 5 = death.)
Measured: up to one year post treatment
Incidence of Urinary Bother
Urinary bother, according to Common Toxicity Criteria for Adverse Events (CTCAE) v.4.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening, Grade 5 = death.)
Measured: up to one year post treatment
Rectal Toxicity
Rectal Toxicity, according to Common Toxicity Criteria for Adverse Events (CTCAE) v.4.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening, Grade 5 = death.)
Measured: up to one year post treatment
Number of Patients with Positive Surgical Margins
Surgical specimens will be evaluated by the study pathologist to determine rate of margin positivity.
Measured: 4-10 weeks post radiation therapy
Number of Patients with Extracapsular Extension
Surgical specimens will be evaluated by the study pathologist to determine rate of extracapsular extension.
Measured: 4-10 weeks post radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study start27 Mar 2017
- Primary completion10 Apr 2018
- Study completion12 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Spratt, M.D., Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946008
- Sponsor's protocol ID
- UMCC 2016.106
- Other IDs
- HUM00120414
- Status last verified
- Nov 2019
- First submitted
- 25 Oct 2016
- Last updated
- 27 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Hammer L, Jiang R, Hearn J, Lashbrook J, Mitchell A, Daignault-Newton S, Dess RT, Jackson WC, Reichert Z, Alumkal JJ, Kaffenberger S, George A, Montgomery J, Salami SS, Morgan TM, Miller D, Wittman D, Hollenbeck B, Mehra R, Davenport MS, Sun Y, Schipper M, Palapattu G, Spratt DE. A Phase I Trial of Neoadjuvant Stereotactic Body Radiotherapy Prior to Radical Prostatectomy for Locally Advanced Prostate Cancer. Int J Radiat Oncol Biol Phys. 2023 Jan 1;115(1):132-141. doi: 10.1016/j.ijrobp.2022.07.016. Epub 2022 Jul 22.
PubMed 35878714
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Neoadjuvant Stereotactic Body Radiotherapy Prior to Radical Prostatectomy for High Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT02946008
- Acronym / sponsor ID
- UMCC 2016.106
- Conditions
- Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 10 Apr 2018 (actual)
- Study completion
- 12 Jul 2019 (actual)
- First posted
- 26 Oct 2016 (estimated)
- 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 is a single-arm prospective non-randomized, non-blinded trial to assess the safety of neoadjuvant stereotactic body radiation therapy (SBRT) before surgery in high risk prostate cancer patients.
Radiation therapy will be delivered over 5 treatment sessions for approximately 1.5 weeks total.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT | Experimental | Radiation: Stereotactic Body Radiation Therapy, Procedure: Radical ProstatectomyStereotactic Body Radiation Therapy (SBRT) will be delivered over 5 treatment sessions for approximately 1.5 weeks total. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subjects must have biopsy-confirmed adenocarcinoma of the prostate.
- Subjects must have a negative bone scan.
- Subjects must have one of the following risk factors:
- PSA ≥20 and/or
- Gleason score ≥8 and/or
Key exclusion criteria (4 listed)
- Metastatic disease as demonstrated by bone scan, CT scan or MRI (Magnetic Resonance Imaging) of the pelvis, or chest x-ray.
- Declared high-risk for anesthesia by attending anesthesiologist, cardiologist, or other physician.
- History of prior pelvic radiation therapy.
- History of androgen deprivation therapy within the past 6 months.
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 TherapyDelivered over 5 treatment sessions for approximately 1.5 weeks total. | Radiation | SBRT |
| Radical ProstatectomyOpen, laparoscopic, or robotic radical prostatectomy and pelvic lymph node dissection to remove the prostate, seminal vesicles, and pelvic lymph nodes. | Procedure or surgery | SBRT |
Primary outcome
Maximum Tolerated Dose (MTD) of Neoadjuvant SBRT
Time frame: 6-week post-prostatectomy
The MTD is defined as the SBRT dose that with radical prostatectomy induces dose-limiting toxicity in 28% of subjects or less.
6 secondary outcomes
Incidence of Urinary Incontinence
Time frame: up to one year post treatment
Incidence of Urinary Stricture
Time frame: up to one year post treatment
Incidence of Urinary Bother
Time frame: up to one year post treatment
Rectal Toxicity
Time frame: up to one year post treatment
Number of Patients with Positive Surgical Margins
Time frame: 4-10 weeks post radiation therapy
Number of Patients with Extracapsular Extension
Time frame: 4-10 weeks post radiation therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
- Derived from this study: PubMed 35878714Hammer L, Jiang R, Hearn J, Lashbrook J, Mitchell A, Daignault-Newton S, Dess RT, Jackson WC, Reichert Z, Alumkal JJ, Kaffenberger S, George A, Montgomery J, Salami SS, Morgan TM, Miller D, Wittman D, Hollenbeck B, Mehra R, Davenport MS, Sun Y, Schipper M, Palapattu G, Spratt DE. A Phase I Trial of Neoadjuvant Stereotactic Body Radiotherapy Prior to Radical Prostatectomy for Locally Advanced Prostate Cancer. Int J Radiat Oncol Biol Phys. 2023 Jan 1;115(1):132-141. doi: 10.1016/j.ijrobp.2022.07.016. Epub 2022 Jul 22.
- Individual participant dataSharing planned: Undecided
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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.
Daniel Spratt, M.D. principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Stereotactic Body Radiation Therapy and Radical Prostatectomy in people with Prostate Cancer, run by University of Michigan Rogel Cancer Center 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 15 inclusion and 4 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 27 Nov 2019. 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 (MTD) of Neoadjuvant SBRT (time frame: 6-week 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 NCT02946008, 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 27 Nov 2019.