AzTrials
AzTrials

Prostate CancerPhase 1NCT04486755

Hypofractionated Accelerated Pelvic Nodal Radiotherapy (GCC 2048)

A Phase 1 study testing Hypofractionated Radiation Therapy in people with Prostate Cancer and Prostate Adenocarcinoma, run by University of Maryland, Baltimore 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

A phase I trial to determine the safety of delivering three sequentially shorter RT schedules (20, 16, and 12 fractions) of HypoFx pelvic nodal RT in combination with a HypoFx, simultaneous integrated boost (SIB) to the prostate that have been designed to incrementally increased the biological equivalent dose (BED) to… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer, Prostate Adenocarcinoma
What is being tested?
Hypofractionated Radiation Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
19 Nov 2020to Aug 2027
Phase
Phase 1
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

  • Patient age is ≥ 18 years
  • Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration.
  • Patient's with intermediate to high risk prostate cancer and must be recommended to undergo pelvic as well as prostatic irradiation.
  • History/physical examination (to include at a minimum digital rectal examination of the prostate and examination of the skeletal system and abdomen) within 90 days prior to registration.
  • Clinically negative lymph nodes as established by imaging (pelvic ± abdominal CT or MR), (but not by nodal sampling, or dissection) within 120 days prior to registration.
  • Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are ≤ 1.5 cm.
Show all 11Show fewer
  • No evidence of bone metastases (M0) on bone scan within 120 days prior to registration.
  • Equivocal bone scan findings are allowed if plain films (or CT or MRI) are negative for metastasis.
  • Baseline serum PSA value performed within 12 weeks (90 days) prior to registration.
  • ECOG Performance Status 0-1
  • Patient must be able to provide study specific informed consent prior to study entry.

Who cannot join

  • Evidence of distant metastases
  • Regional lymph node involvement
  • Previous radical surgery (prostatectomy), cryosurgery, or HIFU (High-intensity focused ultrasound) for prostate cancer
  • Previous pelvic irradiation or prostate brachytherapy
  • Planned prostate brachytherapy boost
  • Previous or concurrent cytotoxic chemotherapy for prostate cancer
Show all 11Show fewer
  • Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
  • Patients are excluded if they have a history of autoimmune disease that, in the opinion of the treating physician would be a contraindication to pelvic radiation (e.g., active systemic lupus, progressive scleroderma)
  • Patients receiving full-dose anticoagulation or clopidogrel
  • Patients taking 81 mg Aspirin po daily may are still eligible for the study
  • Patients with a history of prior small bowel ulceration

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Maryland Proton Treatment Center

    Baltimore, Maryland, 21201

Other trials in United States

About this study

Official title: A Phase I Dose Escalation Study of Hypofractionated Accelerated Pelvic Nodal Radiotherapy Delivered With A Simultaneously Integrated Prostate Boost For Patients With Localized, Intermediate- And High-Risk Prostate Cancer (GCC 2048)

A phase I trial to determine the safety of delivering three sequentially shorter RT schedules (20, 16, and 12 fractions) of HypoFx pelvic nodal RT in combination with a HypoFx, simultaneous integrated boost (SIB) to the prostate that have been designed to incrementally increased the biological equivalent dose (BED) to prostate cancer, while maintaining a constant BED to normal tissue toxicity.

Read the detailed description

Outcomes for patients with unfavorable intermediate-risk and high-risk prostate cancer (PC) have been historically poor and are now known to require multimodality treatment. A standard non-surgical treatment option for patients with localized, intermediate and high-risk PC is radiation therapy (RT) in combination with short- or long-term androgen deprivation therapy (ADT).

The benefit of pelvic nodal RT in this setting is unclear, previous studies have been equivocal. There is a growing body of evidence to demonstrate that use of hypofractionated (HypoFx) RT may be a safe method for increasing the dose of RT, while also decreasing normal tissue toxicity.

Being tested
Hypofractionated Radiation Therapy
Keywords
Prostate, Hypofractionated Radiation Therapy, Prostate Cancer, Radiotherapy, Proton 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.

  • Hypofractionated Radiation TherapyRadiation

    All patients RT will be delivered utilizing pencil beam scanning proton therapy. Radiation treatment will be delivered 4 days per week.

Study groups in NCT04486755
Study groupRoleWhat they receive
Dose Level 1ExperimentalDose schedules were calculated to maintain similar BED for late normal tissue injury (α/β= 3.0 Gy), with an increased BED for PC (α/β= 1.5Gy). Patients be treated with 20 fractions. A total of 6 patients will be treated at the dose that is determined to be Maximum Tolerated Dose.
Receives: Radiation: Hypofractionated Radiation Therapy
Dose Level 2ExperimentalDose schedules were calculated to maintain similar BED for late normal tissue injury (α/β= 3.0 Gy), with an increased BED for PC (α/β= 1.5Gy). Patients be treated with 16 fractions. A total of 6 patients will be treated at the dose that is determined to be Maximum Tolerated Dose.
Receives: Radiation: Hypofractionated Radiation Therapy
Dose Level 3ExperimentalDose schedules were calculated to maintain similar BED for late normal tissue injury (α/β= 3.0 Gy), with an increased BED for PC (α/β= 1.5Gy). Patients be treated with 12 fractions. A total of 6 patients will be treated at the dose that is determined to be Maximum Tolerated Dose.
Receives: Radiation: Hypofractionated Radiation Therapy

What is being measured

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

  1. HypoFx RT schedule that results in <33% acute dose-limiting toxicity with accelerated, HypoFx pelvic nodal RT

    The frequency of all observed acute GI, GU, hematologic, and neurologic dose limiting toxicities by CTCAE v5 grade will be tabulated. DLT is defined as treatment-related: Grade ≥3 GI (small bowel or rectal) toxicity, Grade ≥3 GU toxicity, Grade ≥3 hematologic, Grade ≥3 neurologic toxicity, or any grade 5 treatment-related adverse events.

    Measured: Within 90 days of completing RT

Secondary outcomes (6)

  1. Frequency of acute and late GI, GU, hematologic, and neurologic toxicity for each dose cohort

    The frequency of the maximum grade acute (within 90 days completing RT) and late (occurring > 90 days from treatment) GI (small bowel and rectal), GU, hematologic, and neurologic toxicities at 3-months, 6 months, 1-year and 2 years for each dose cohort using National Cancer Institute Common Terminology Criteria v.5.0 (NCI CTCAE v5).

    Measured: Acute (within 90 days completing RT), Late (occurring > 90 days from treatment), 3-months, 6 months, 1-year and 2 years

  2. Dose volume histogram (DVH) parameters

    A dose-volume histogram is a histogram relating radiation dose to tissue volume in radiation therapy planning.

    Measured: Within 90 days of completing RT

  3. Evaluate the duration of biochemical progression-free survival

    The duration of bPFS will be measured from the end of RT until either PSA recurrence or death due to any cause and summarized for the expanded cohort of patients treated at the maximum total dose (MTD). PSA recurrence is defined by the Phoenix definition of biochemical failure (PSA nadir + 2 ng/mL).

    Measured: 2 years after completing RT

  4. Patient Reported Outcomes (PROs) related to urinary and bowel function

    Quality of life will be assessed with the validated Expanded Prostate Cancer Index Composite (EPIC) questionnaire.

    Measured: 1 month after completion of treatment, every 3 months for year 1, and every 6 months during Year 2

  5. Patient Reported Outcomes (PROs) related to urinary function

    The International Prostate System Score (IPSS) questionnaire will be used for urinary function.

    Measured: 1 month after completion of treatment, every 3 months for year 1, and every 6 months during Year 2

  6. Patient Reported Outcomes (PROs) related to urinary and bowel function

    The PRO-CTCAE questionnaire measures patient-reported bowel, urinary and sexual function.

    Measured: 1 month after completion of treatment, every 3 months for year 1, and every 6 months during Year 2

Timeline

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

  1. First posted27 Jul 2020
  2. Study start19 Nov 2020
  3. Primary completionAug 2026 (estimated)
  4. Study completionAug 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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
A modified 3+3 study design will be employed to determine the dose-fractionation schedule that results in less than 33% dose limiting toxicity. One de-escalation will be allowed if the initial dose-fractionation schedule results in too high a frequency of dose limiting toxicities. A total of 6 patients will be treated following the dose-fractionation schedule that is recommended for further study.
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04486755
Sponsor's protocol ID
HP-00091499
Status last verified
May 2026
First submitted
15 Jul 2020
Last updated
11 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Hypofractionated Radiation Therapy in people with Prostate Cancer and Prostate Adenocarcinoma, run by University of Maryland, Baltimore 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 11 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 11 May 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 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?

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?

HypoFx RT schedule that results in <33% acute dose-limiting toxicity with accelerated, HypoFx pelvic nodal RT (time frame: Within 90 days of completing RT). 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 NCT04486755.

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 11 May 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