Hypofractionated Accelerated Pelvic Nodal Radiotherapy (GCC 2048)

NCT04486755 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: HP-00091499
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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 prostate cancer, while maintaining a constant BED to normal tissue toxicity.

Conditions

Prostate Cancer; Prostate Adenocarcinoma

Keywords

Prostate; Hypofractionated Radiation Therapy; Prostate Cancer; Radiotherapy; Proton Therapy

Outcome Measures

Primary Outcomes (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.

  Within 90 days of completing RT

Secondary Outcomes (6)

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

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

• Dose volume histogram (DVH) parameters

  Within 90 days of completing RT

• Evaluate the duration of biochemical progression-free survival

  2 years after completing RT

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

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

• Patient Reported Outcomes (PROs) related to urinary function

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

Study Arms (3)

Dose Level 1

EXPERIMENTAL

Dose 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.

Radiation: Hypofractionated Radiation Therapy

Dose Level 2

EXPERIMENTAL

Dose 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.

Radiation: Hypofractionated Radiation Therapy

Dose Level 3

EXPERIMENTAL

Dose 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.

Radiation: Hypofractionated Radiation Therapy

Interventions

Hypofractionated Radiation Therapy RADIATION

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

Dose Level 1; Dose Level 2; Dose Level 3

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

Maryland Proton Treatment Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 27, 2020
• Study Start: November 19, 2020
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)