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Stage III Prostate Cancer AJCC v8NCT04725903

Proton Radiation Therapy for the Treatment of Patients With High Risk Prostate Cancer

A study testing High-Dose Rate Brachytherapy, Proton Beam Radiation Therapy and Quality-of-Life Assessment in people with Stage III Prostate Cancer AJCC v8 and Stage IIIA Prostate Cancer AJCC v8, run by Emory University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This phase II trial investigates whether proton radiation therapy directed to the prostate tumor, pelvic, and para-aortic lymph nodes, is an effective way to treat patients with high-risk or lymph node positive prostate cancer who are receiving radiation therapy, and if it will result in fewer gastrointestinal and… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
High-Dose Rate Brachytherapy, Proton Beam Radiation Therapy and Quality-of-Life Assessment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
1 Feb 2021to 31 Dec 2027
Phase
Interventional
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

  • Pathologically confirmed high-risk prostate cancer fulfilling any one of the following criteria:
  • Gleason grade 8 or higher
  • cT3b (seminal vesicle involvement) or cT4
  • Prostate specific antigen [PSA] > 20 (or PSA >10 if on finasteride)
  • Clinically or pathologically positive regional lymph nodes within the inguinal, external iliac, internal iliac, obturator, peri-rectal, pre-sacral, common iliac, or lower para-oaortc (inferior to the L2-L3 interspace) basins
  • Zubrod performance status 0-2
Show all 11Show fewer
  • Complete blood cell (CBC)/differential obtained within 90 days prior to registration on study
  • Absolute neutrophil count (ANC) >= 1,500 cells/mm^3
  • Platelets >= 100,000 cells/mm^3
  • Hemoglobin >= 8.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)
  • Patient must be able to provide study specific informed consent

Who cannot join

  • Absence of bone metastasis by bone scan or metabolic imaging (e.g. NaF PET, FACBC PET, PSMA PET, etc.) before the start of therapy.
  • Absence of distant lymph node metastasis by CT and/or MRI before the start of therapy.
  • Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
  • Prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation therapy fields
  • Uncontrolled intercurrent illness including, but not limited to, inflammatory bowel disease, human immunodeficiency virus infection, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Pretesh Patel, MD contact

404-778-3473

pretesh.patel@emory.edu

United States1 site, 1 recruiting

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

    Ardith R. DeShay, 404-686-1858, adeshay@emory.edu

    Pretesh R. Patel, MD

    Recruiting

Other trials in United States

About this study

Official title: Extended-Field Lymph Node Proton Irradiation for High Risk Prostate Cancer

This phase II trial investigates whether proton radiation therapy directed to the prostate tumor, pelvic, and para-aortic lymph nodes, is an effective way to treat patients with high-risk or lymph node positive prostate cancer who are receiving radiation therapy, and if it will result in fewer gastrointestinal and genitourinary side effects. Proton beam therapy is a new type of radiotherapy that directs multiple beams of protons (positively charged subatomic particles) at the tumor target, where they deposit the bulk of their energy with essentially no residual radiation beyond the tumor. By reducing the exposure of the healthy tissues and organs to radiation in the treatment of prostate cancer, proton therapy has the potential to better spare healthy tissue and reduce the side effects of radiation therapy.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine the rate of acute grade 2+ gastrointestinal toxicity compared to historical photon treatments.

SECONDARY OBJECTIVES:

  1. To determine the rate of acute grade 2+ genitourinary toxicity compared to historical photon treatments.

II. To assess the feasibility of extended-field proton irradiation of high-risk prostate.

III. To demonstrate safety of proton therapy followed by high dose rate (HDR) boost.

IV. To determine patient-reported outcomes (PROs) of toxicity.

OUTLINE:

Patients undergo conventionally fractionated proton beam therapy daily on Monday-Friday. Patients may receive a high-dose rate brachytherapy boost.

After completion of study treatment, patients are followed up at 1, 3, 6, 9 and 12 months, and 1.5, 2, 2.5, and 3 years.

Being tested
High-Dose Rate Brachytherapy, Proton Beam Radiation Therapy, Quality-of-Life Assessment, Survey Administration
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • High-Dose Rate BrachytherapyRadiation

    Also called Brachytherapy, High Dose

    Receive high-dose rate brachytherapy boost

  • Proton Beam Radiation TherapyRadiation

    Also called PBRT, Proton, Proton Radiation Therapy, Radiation, Proton Beam

    Undergo proton beam therapy

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Survey AdministrationOther

    Ancillary studies

Study groups in NCT04725903
Study groupRoleWhat they receive
Treatment (proton beam therapy)ExperimentalPatients undergo conventionally fractionated or hypofractionated proton beam therapy daily on Monday-Friday directed to the prostate, pelvic lymph nodes, and para-aortic lymph nodes. Patients may receive an optional high-dose rate brachytherapy boost. Androgen deprivation therapy is required but left to the discretion of the treating physician.
Receives: Radiation: High-Dose Rate Brachytherapy; Radiation: Proton Beam Radiation Therapy; Other: Quality-of-Life Assessment; Other: Survey Administration

What is being measured

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

  1. Acute grade 2+ gastrointestinal (GI) toxicity

    The rate of grade 2+ gastrointestinal toxicity within 30 days of receiving radiation therapy (RT) will be measured. It will be compared to the theorized reduction to 24% toxicity using the exact binomial test. Assessments are based on version 5 Common Terminology Criteria for Adverse Events (CTCAE), and the worst severity of GI toxicity will be assessed.

    Measured: Up to 3 years

Secondary outcomes (9)

  1. Acute grade 2+ genitourinary (GU) toxicity rate

    The rate of grade 2+ genitourinary toxicity within 30 days of receiving radiation therapy (RT) will be measured. Assessments are based on version 5 CTCAE, and the worst severity of GU toxicity will also be assessed.

    Measured: Up to 3 years

  2. Optimal frequency of cone beam computed tomography (CT)

    Will determine the optimal frequency of cone beam CT during treatment and assess subsequent need for adaptive re-planning. The feasibility of extended-field proton irradiation of high-risk prostate cancer will be estimated using a re-planning rate of less than 10%. The re-planning rate will be estimated as binary variable, yes or no. The exact 95% confidence interval (CI) around the 10 % re-planning count based on the binomial distribution for the estimated 30 patients will be used (0.021-0.265). The study will be deemed feasible if the observed rate is not higher than the upper bound of the estimated 95% CI.

    Measured: Through study completion, an average of 1 year

  3. Patient reported health related quality of life (QOL) - PRO-CTCAU GI

    Assessed using Patient Reported Outcomes-CTCAE GI toxicity

    Measured: Up to 3 years

  4. Patient reported health related quality of life (QOL) - PRO-CTCAU GU

    Assessed using Patient Reported Outcomes-CTCAE GU toxicity

    Measured: Up to 3 years

  5. Patient reported health related quality of life (QOL) - IPSS

    International Prostate Symptom Score (IPSS)

    Measured: Up to 3 years

  6. Patient reported health related quality of life (QOL) - EPIC-CP

    Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP)

    Measured: Up to 3 years

  7. Chronic GI Toxicity

    The rate of any grade gastrointestinal toxicity occurring after 90 days from the completion of radiation therapy(RT). Assessments are based on version 5 Common Terminology Criteria for Adverse Events (CTCAE), and the worst severity of GI toxicity will be assessed.

    Measured: Up to 3 years

  8. Chronic GU Toxicity

    The rate of any grade genitourinary toxicity occurring after 90 days from the completion of radiation therapy(RT). Assessments are based on version 5 Common Terminology Criteria for Adverse Events (CTCAE), and the worst severity of GU toxicity will be assessed.

    Measured: Up to 3 years

  9. Biochemical failure

    Assessed by the Phoenix definition (prostate specific antigen [PSA] >= 2 ng/ml over the nadir PSA).

    Measured: Baseline up to pre-RT

Timeline

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

  1. First posted27 Jan 2021
  2. Study start1 Feb 2021
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04725903
Sponsor's protocol ID
STUDY00000329
Other IDs
NCI-2020-07113, RAD5131-20, P30CA138292
Status last verified
Feb 2026
First submitted
8 Jan 2021
Last updated
17 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: Results of the trial and not individual patient data will be shared. The study protocol, consent, and investigator's brochure will be available. The statistical plan is incorporated into the protocol, along with inclusion and exclusion criteria.

Questions about this trial

What is this clinical trial studying?

A study testing High-Dose Rate Brachytherapy, Proton Beam Radiation Therapy and Quality-of-Life Assessment in people with Stage III Prostate Cancer AJCC v8 and Stage IIIA Prostate Cancer AJCC v8, run by Emory University 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: looking for participants now, as of the sponsor's last update on 17 Feb 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.

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?

Contact Pretesh Patel, MD (404-778-3473, pretesh.patel@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute grade 2+ gastrointestinal (GI) toxicity (time frame: Up to 3 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 NCT04725903.

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 17 Feb 2026.

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