AzTrials
AzTrials

Prostate CancerPhase 2NCT04842890

Phase II Study of Pencil Beam Scanning Proton Stereotactic Body Radiation Therapy for Prostate Cancer

A Phase 2 study testing Pencil Beam Scanning Proton SBRT in people with Prostate Cancer, run by The New York Proton Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a single arm phase II study of image-guided pencil beam scanning proton SBRT (40Gy RBE in 5 fractions delivered every other day) for patients with low- and intermediate-risk prostate cancer. 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?
Pencil Beam Scanning Proton SBRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
1 siteUnited States
Study dates
8 Jan 2021to Jan 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Biopsy-proven NCCN low- or intermediate-risk prostate cancer, which includes patients with:
  • Gleason score ≤7 disease
  • PSA ≤20 ng/ml
  • Clinical T1-T2c disease
  • Note: Patients who only have radiographic evidence of possible or probable T3 disease (i.e., extracapsular extension or seminal vesical invasion) will not be excluded.
  • KPS ≥ 80%
Show all 11Show fewer
  • Prostate size as determined on MRI to be < 100 cc. Prostate size can be determined on CT scan if MRI is not available.
  • Male 18 years of age or older
  • IPSS ≤ 20
  • Patient must be a candidate for and agree to placement of intraprostatic fiducial markers and a hydrogel rectal spacer
  • Patient must be available for at least 2 years of follow-up

Who cannot join

  • Prior prostate surgery (including cryosurgery)
  • Note: Patients who underwent TURP or greenlight PVP are eligible if it was > 12 weeks prior to the anticipated start date of SBRT
  • Prior history of chronic prostatitis or urethral stricture
  • Currently active cancer(s) other than non-melanoma skin cancers. Patients are not considered to have currently active cancers if they have completed therapy and are considered by their physicians to be at <5% risk of relapse within 2 years.
  • Life expectancy of < 2 years

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The New York Proton Center

    New York, New York, 10035

Other trials in United States

About this study

This is a single arm phase II study of image-guided pencil beam scanning proton SBRT (40Gy RBE in 5 fractions delivered every other day) for patients with low- and intermediate-risk prostate cancer. The primary aim is to assess GU/GI toxicity of proton SBRT and compare this to historic outcomes associated with photon-based prostate SBRT. The primary endpoint is 2-year grade 3+ GU/GI toxicity free rate by CTCAE v5.0, which is expected to be ≥95%. Toxicity will be evaluated by the treating radiation oncologist at least once during SBRT, then following SBRT at 1, 3, 6, 12, 18, and 24 months. The treatment will be considered safe if grade 3 or higher GU/GI toxicity free rate at 2 years is >85% (95% rate expected with a 10% non-inferiority margin). The accrual goal is 61 patients over 3 years. To ensure that unexpected significant toxicity is identified, all grade 3 or higher toxicities will be reported to the study PI and the trial will stop accruing if at any point 4 or more patients experience a grade 3 or higher toxicity after completing SBRT. This is felt to be conservative given the vast experience with photon SBRT at this dose with an expected G3+ toxicity of ~5%.

Secondary objectives are to examine patient-reported urinary, gastrointestinal, sexual, and financial outcomes using IPSS, EPIC-26, and COST questionnaires at the same follow-up timepoints as above. Baseline measures of these domains will be obtained prior to treatment as well. Clinical outcomes will also be evaluated with PSA measured at each follow-up, as well as prostate MRI and biopsies at 2 years. Patients will be followed for at least 2 years to determine rates of PSA relapse, salvage treatment, development of metastases, death from prostate cancer, and overall survival. A dosimetric comparison will be performed where each patient will be planned for proton and photon SBRT to determine possible advantages of proton SBRT.

Conditions
Prostate Cancer
Being tested
Pencil Beam Scanning Proton SBRT
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Pencil Beam Scanning Proton SBRTRadiation

    The intervention being investigated is ultra-hypofractionated, image-guided, pencil beam scanning proton SBRT directed at the prostate gland and seminal vesicles to 40 Gy equivalent in 5 fractions, delivered every other day.

Study groups in NCT04842890
Study groupRoleWhat they receive
Stereotactic body radiation therapy (SBRT) with Pencil Beam Scanning (PBS) proton therapyOtherNot described
Receives: Radiation: Pencil Beam Scanning Proton SBRT

What is being measured

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

  1. 1. Grade 3+ GU/GI toxicity-free rate determined by CTCAE v5.0 grading.

    The NCI Common Terminology Criteria for Adverse Events v5.0 is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term.

    Measured: 2 years

Secondary outcomes (9)

  1. 1. Patient reported urinary symptoms determined by IPSS.

    The International Prostate Symptom Score (IPSS) was developed to assess the severity of lower urinary tract symptoms associated to Benign Prostatic Hyperplasia and has also been applied to other conditions that cause LUTS. The IPSS consists of a total of seven questions that deal with voiding symptoms (incomplete empty, intermittency, weak stream and straining to void) and storage symptoms (frequency, urgency and nocturia) and an additional question to measure quality of life. The score ranges from 0 to 35, with lower scores denoting a better health state.

    Measured: 2 years

  2. 2. Patient reported urinary, bowel, and hormonal quality of life determined by EPIC-26.

    EPIC-26 is the "Expanded Prostate Cancer Index Composite" patient reported outcomes questionnaire. A clinical tool to assess urinary, bowel, sexual and vitality health. The score from each of the 5 domains runs from 0 (none) to 12 (severe) impact on quality of life. Each domain score when added together gives an overall score of zero (unaffected) to 60 (severely affected)

    Measured: 2 years

  3. 3. Patient reported financial toxicity determined by COST

    Comprehensive Score for Financial Toxicity Functional Assessment of Chronic Illness Therapy (COST-FACIT) was developed as part of a series of questionnaires aimed at measuring different symptom indexes of health-related quality of life in patients with advance disease such as cancer. The survey contains 12 questions and each of them is rated from 0 (not at all) to 4 (very much). This survey focuses on financial distress caused by illness in patients with cancer. It takes about 5 minutes to complete.

    Measured: 2 years

  4. 4. 2-year and 5-year biochemical progression free survival

    Biochemical failure is defined as a sustained rise in PSA of 2 ng/mL or more above the nadir (the lowest PSA level after radiotherapy).

    Measured: 2 years and 5 years

  5. 5. 2-year local control determined by MRI and biopsies

    Measured: 2 years

  6. 6. 2-year and 5-year metastasis free survival

    Measured: 2 years and 5 years

  7. 7. 2-year and 5-year prostate cancer specific survival

    Measured: 2 years and 5 years

  8. 8. 2-year and 5-year overall survival

    Measured: 2 years and 5 years

  9. 9. Dosimetric advantages determined by target coverage, conformality, and normal tissue sparing

    Measured: 2 years

Timeline

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

  1. First posted13 Apr 2021
  2. Study start8 Jan 2021
  3. Primary completionJun 2026 (estimated)
  4. Study completionJan 2031 (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
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04842890
Sponsor's protocol ID
NYPC ERC# 2020-027
Status last verified
Apr 2026
First submitted
15 Mar 2021
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pencil Beam Scanning Proton SBRT in people with Prostate Cancer, run by The New York Proton 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 11 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. 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 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?

This study is still under way. Results are not available in the source record yet.

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?

1. Grade 3+ GU/GI toxicity-free rate determined by CTCAE v5.0 grading. (time frame: 2 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 NCT04842890.

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 13 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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