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Trial record 16 of 67 for:    Recruiting Studies | Prostate Cancer | Florida, United States

Dose-Escalated Proton Radiation Therapy for High-Risk Prostate Cancer (PR11)

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ClinicalTrials.gov Identifier: NCT03624660
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief Summary:
The purpose of this research study is to determine if dose-escalated proton radiation therapy is a good way to treat high-risk prostate cancer. The study features hypofractionation and a simultaneous integrated boost to the magnetic resonance imaging (MRI) identified intraprostatic tumor (IPT) as a method of dose-escalating radiation therapy. The study will include patients with high-risk prostate cancer who are at the highest risk for recurrence. Radiation therapy will be delivered over the course of 8-9 weeks. Additionally, androgen deprivation therapy (ADT) will be started 8-10 weeks prior to starting radiation and continued for a total of 18 months.

Condition or disease Intervention/treatment Phase
Adenocarcinoma of the Prostate Radiation: HR-A Radiation: HR-B Radiation: HR-C Not Applicable

Detailed Description:

Prostate cancer is the most common noncutaneous cancer among men in the United States. The purpose of this research study is to determine if dose-escalated proton radiation therapy is a good way to treat high-risk prostate cancer.

Proton therapy (PT) is a type of ionizing radiation therapy that reduces the dose of excess radiation delivered to normal tissues. By escalating the radiation dose just to the area of the known tumor within the prostate, one could potentially reduce the amount of excess radiation delivered to surrounding organs.This reduction in dose would improve the therapeutic ratio by improving disease control while minimizing the risk for additional toxicity.

In an effort to take advantage of dose escalation's potential for improving disease control but also to limit toxicity, the use of advanced imaging to identify prostate cancer and provide a focal radiation boost to the area have proven to be useful. Recent advances in MRI have made it the most promising technique in identifying and targeting IPTs, improving both cancer control rates and decreasing toxicity.

The study features hypofractionation and a simultaneous integrated boost to the MRI identified intraprostatic tumor (IPT) as a method of dose-escalating radiation therapy. The study will include patients with high-risk prostate cancer who are at the highest risk for recurrence. Radiation therapy will be delivered over the course of 8-9 weeks. Additionally, androgen deprivation therapy (ADT) will be started 8-10 weeks prior to starting radiation and continued for a total of 18 months.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Patients will be assigned to treatment group according to their lymph node risk.

3 treatment groups:

  • HR-A: Patients with <25% risk of positive pelvic nodes, without posterior extracapsular extension and negative for seminal vesicle invasion on exam pretreatment diagnostic MRI.
  • HR-B: Patient with ≥ 25% risk of positive pelvic nodes, without posterior extracapsular extension and negative for seminal vesicle invasion.
  • HR-C: Patients with seminal vesicle invasion.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Dose-Escalated Proton-Based Radiation Therapy Delivered With a Simultaneous Integrated Boost (SIB) to Intraprostatic Tumors (IPT) Visible on Pretreatment Magnetic Resonance Image
Actual Study Start Date : September 24, 2018
Estimated Primary Completion Date : September 2028
Estimated Study Completion Date : September 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HR-A (High-risk A)
  • Prostate and proximal seminal vesicles: 2 cobalt gray equivalent per fraction to a total dose of 78 cobalt gray equivalent.
  • Simultaneous integrated boost to the IPT: 2.2 cobalt gray equivalent per fraction to a total dose of 85.8 cobalt gray equivalent.
Radiation: HR-A

The prostate and proximal seminal vesicles will be treated to 2 cobalt gray equivalent per fraction for 39 fractions for a total of 78 cobalt gray equivalent.

Simultaneous integrated boost to the IPT will be delivered to 2.2 cobalt gray equivalent per fraction for 39 fractions for a total of 85.8 cobalt gray equivalent.

Treatment will be given once a day, approximately 5 treatments per week (Monday- Friday), over 8-9 weeks.

Other Name: Proton Radiation

Experimental: HR-B (High-risk B)
  • Prostate, proximal seminal vesicles, and pelvic nodes: 2 cobalt gray equivalent per fraction to a total does of 46 cobalt gray equivalent.
  • Prostate and proximal seminal vesicles: 2 cobalt gray equivalent per fraction to a total dose of 32 cobalt gray equivalent.
  • Simultaneous integrated boost to the IPT: 2.2 cobalt gray equivalent per fraction to a total dose of 85.8 cobalt gray equivalent.
Radiation: HR-B

The prostate, proximal seminal vesicles, and pelvic nodes will be treated to 2 cobalt gray equivalent per fraction for 23 fractions for a total of 46 cobalt gray equivalent.

The prostate and proximal seminal vesicles will be treated to an additional 2 cobalt gray equivalent per fraction for 16 fractions for a total of 32 cobalt gray equivalent.

Simultaneous integrated boost to the IPT will be delivered to 2.2 cobalt gray equivalent per fraction for 39 fractions for a total of 85.8 cobalt gray equivalent.

Treatment will be given once a day, approximately 5 treatments per week (Monday- Friday), over 8-9 weeks.

Other Name: Proton Radiation

Experimental: HR-C (High-risk C)
  • Prostate, entire seminal vesicles, and pelvic nodes: 2 cobalt gray equivalent per fraction to a total dose of 46 cobalt gray equivalent.
  • Prostate and entire involved seminal vesicles: 2 cobalt gray equivalent per fraction to a total dose of 14 cobalt gray equivalent.
  • Prostate, entire involved seminal vesicle, and at least the proximal seminal vesicle on uninvolved side: 2 cobalt gray equivalent per fraction to a total dose of 18 cobalt gray equivalent.
  • Simultaneous integrated boost to the IPT: 2.2 cobalt gray equivalent per fraction to a total dose of 85.8 cobalt gray equivalent.
Radiation: HR-C

The prostate, entire seminal vesicles, and pelvic nodes will be treated to 2 cobalt gray equivalent per fraction for 23 fractions for a total of 46 cobalt gray equivalent.

The prostate and entire involved seminal vesicles will be treated to an additional 2 cobalt gray equivalent per fraction for 7 fractions for a total of 14 cobalt gray equivalent.

The prostate, entire involved seminal vesicle, and at least the proximal seminal vesicle on the uninvolved side will be treated to an additional 2 cobalt gray equivalent per fraction for 9 fractions for a total of 18 cobalt gray equivalent.

Simultaneous integrated boost to the IPT will be delivered to 2.2 cobalt gray equivalent per fraction for 39 fractions for a total of 85.8 cobalt gray equivalent.

Treatment will be given once a day, approximately 5 treatments per week (Monday- Friday), over 8-9 weeks.

Other Name: Proton Radiation




Primary Outcome Measures :
  1. Cumulative rate of biochemical failure at 5 years after the end of treatment. [ Time Frame: 5 years after the end of radiation therapy ]
    Biochemical failure will be defined based on the Phoenix definition. Biochemical failure has occurred if the post-treatment prostate-specific antigen (PSA) on at least two occasions rose more than 2 ng/ml above the PSA nadir. Rate of biochemical failure will be measured at 5 years after the end of treatment.


Secondary Outcome Measures :
  1. Cumulative rate of acute toxicity observed between day 1 of treatment and 90 days after treatment. [ Time Frame: 90 days after the end of radiation therapy ]
    Assess physician-graded, severe (Grade 3-4), acute (early, within 90 days of treatment) genitourinary and gastrointestinal toxicity rates based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  2. Cumulative rate of late toxicity observed between 90 days and 5 years after end of treatment. [ Time Frame: 60 months after the end of radiation therapy ]
    Assess physician-graded, severe (Grade 3-4), late (beginning 90 or more days after treatment), cumulative 5 year genitourinary and gastrointestinal toxicity rates based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  3. Rate of change in sexual, bowel, and urinary function from baseline measurement to 5 years after end of treatment. [ Time Frame: Rate of change between baseline measurement and 5 years end of radiation therapy ]
    Assess changes in patient-reported quality of life before and after treatment according to The International Index of Erectile Function (IIEF-5/IIEF-5m) which measures sexual function and the effect of radiation therapy; The International Prostate Symptom Score (IPSS) which measures urinary function and the effect of radiation therapy; and The Expanded Prostate Cancer Index Composite (EPIC) which measures different areas that may be affected by prostate cancer or its treatment.

  4. Assessment of overall and disease-free survival [ Time Frame: 5 years after the end of radiation therapy ]
    Assess the overall survival, defined as the time from the start of treatment to the date of death of any cause, if data is available, at 5 years. Also, cause-specific survival will be calculated.

  5. Assessment of local persistence or local recurrence [ Time Frame: 5 years after the end of radiation therapy ]
    Assess local persistence or local recurrence of prostate cancer at 5 years. Local persistence is defined as the failure of the original abnormal tumor mass seen on cross sectional imaging and/or found on digital rectal exam to resolve in patients who also had a poor PSA response with a PSA nadir greater than 1 ng/mL. Local recurrence is defined as the development of any new abnormal prostate mass on cross sectional imaging or on digital rectal exam with previous exams or imaging showing no mass in the area prior to radiation therapy or after initial treatment.

  6. Rate of distant metastases five years after end of radiation therapy [ Time Frame: 5 years after the end of radiation therapy ]
    Assess the cumulative rate development of distant metastasis up to 5 years after end of radiation. This will be an aggregate binary, yes/no response based on evidence acquired from sources including CT scan, bone scan, and/or PET/CT scan.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Prostate cancer is gender-specific. Biological males only.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must give study-specific informed consent on an IRB-approved consent prior to any research related procedures or study treatment.
  • Patient must be at least 18 years at the time of consent.
  • Adenocarcinoma of the prostate with AJCC Clinical Stage T1to T3b disease with histological evaluation via biopsy or repeat biopsy within 12 months prior to registration.
  • Patients must undergo a pretreatment diagnostic MRI of the prostate on a 1.5T to 3T Tesla machine within 6 months prior to study registration.
  • A focal IPT must be visible on MRI within the prostate and/or seminal vesicles and this MRI must be obtained within 6 months of planning CT scan.
  • A biopsy of the dominant lesion is recommended but not required. If an ultrasound guided sextant biopsy was positive for prostatic adenocarcinoma in the area of the MRI identified intraprostatic lesion, this will be acceptable and another guided biopsy targeting the MRI identified disease will not be necessary.
  • Patients with at least one of the following high-risk factors: cT3a-T3b OR Gleason 9-10 OR PSA > 30 OR more than 1 high-risk factors must be present: clinical stage of T3, Gleason score 8-10, or PSA 20 ng/ml or greater.
  • Hemoglobin must be ≥ 10 g/ml within 4 months prior to registration.
  • Zubrod performance status must be 0-1 within 3 months prior to registration.
  • If patient has child-producing potential, they must be willing to use medically acceptable contraception during treatment and must be advised to use it for at least 1 year thereafter. This is not applicable if the patient is not sexually active or has had a vasectomy.
  • Patients must be able to start treatment within 16 weeks of registration.

Exclusion Criteria:

  • T4 prostate disease on CT, MRI, or physical exam.
  • Patients unable to undergo MRI of the prostate.
  • Patients with a greater than 25% change in prostate volume from the pretreatment MRI of the prostate demonstrating the IPT and the treatment planning MRI. Patients in this case must undergo a repeat diagnostic MRI on a 1.5T to 3.0T Tesla machine and an IPT must still be visible.
  • Patients with posterior or posterolateral extracapsular extension of prostate cancer. If this is present, it must resolve on diagnostic MRI after 2 to 3 months of neoadjuvant androgen deprivation therapy prior to enrollment.
  • IPT that is more than 75% of the prostate volume when measured on the CT simulation scan.
  • Evidence of distant metastasis (M1).
  • Patients with positive nodes on cross-sectional imaging.
  • Previous prostate cancer local treatment including prostatectomy, hyperthermia, high intensity focused ultrasound, brachytherapy, external-beam radiation therapy, and/or cryotherapy.
  • Prior pelvic radiation therapy.
  • No prior myocardial infarction within the last 6 months, congestive heart failure, or end stage renal disease.
  • Active inflammatory bowel disease (diverticulitis, Crohn's disease, ulcerative colitis) affecting the rectum.
  • Bilateral hip replacement
  • Prior intrapelvic surgery. This includes the following:

    • Bladder surgery
    • Transrectal or rectal surgery other than prostate biopsy
    • Polypectomy or hemorrhoid removal or banding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03624660


Contacts
Contact: Intake Coordinator 877-686-6009 jinpark@floridaproton.org

Locations
United States, Florida
University of Florida Health Proton Therapy Institute Recruiting
Jacksonville, Florida, United States, 32206
Contact: Intake Coordinator    877-866-6009      
Principal Investigator: Curtis M Bryant, MD, MPH         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Curtis M Bryant, MD, MPH University of Florida Health Proton Therapy Institute

Additional Information:
Publications:
American Joint Committee on Cancer. AJCC Cancer Staging Manual. 8thedition ed. New York, NY: Springer; 2017.
Van Vulpen M, Van Loon J, Pos F, et al. OC-0282: FLAME randomised trial: 95Gy MRI-boost vs 77Gy prostate radiotherapy: toxicity and quality of life. Radiother Oncol. 2016;119(1 Suppl):S132.
American Cancer Society. Cancer Facts & Figures 2016. 2016; https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2016.html. Accessed 10/03/2017.
National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer. 2017; https://www.nccn.org/professionals/physician_gls/PDF/prostate.pdf. Accessed 10/03/2017.
Michalski JM, Moughan J, Purdy JA, et al. Initial Results of a Phase 3 Randomized Study of High Dose 3DCRT/IMRT versus Standard Dose 3D-CRT/IMRT in Patients Treated for Localized Prostate Cancer (RTOG 0126). Int J Radiat Oncol Biol Phys. 2014;90(5):1263.
Nabid A, Carrier N, Martin AG, et al. Duration of androgen deprivation therapy in high-risk prostate cancer: A randomized trial. J Clin Oncol. 2013;31(18 Suppl):LBA4510.

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03624660     History of Changes
Other Study ID Numbers: IRB201800933
UFPTI 1712-PR11 ( Other Identifier: Proton Therapy Institute ID )
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
High-risk
Prostate cancer
Proton Radiation
Dose-escalated
Hypofractionation
Simultaneous Integrated Boost (SIB)
Intraprostatic Tumor (IPT)
Proton Therapy (PT)
Androgen Deprivation Therapy (ADT)
Magnetic Resonance Imaging (MRI)

Additional relevant MeSH terms:
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Adenocarcinoma
Carcinoma
Genital Diseases, Male
Cobalt
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs