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Randomized Phase II Trial of Salvage Radiotherapy for Prostate Cancer In 4 Weeks v. 2 Weeks

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04422132
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : July 5, 2022
Sponsor:
Collaborator:
Viewray Inc.
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Description
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Brief Summary:
The purpose of this study is to compare urinary and bowel side effects of hypofractionated radiotherapy in 20 treatments (4 weeks) to ultra-hypofractionated radiotherapy in 5 treatments (2 weeks) for prostate cancer that has returned after prostatectomy. The investigators are also interested in looking at time to progression and the quality of life (health scores).

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: 5 days Radiation Therapy (32.5 Gy in 5 fractions) Radiation: 20 days Radiation therapy (55 Gy in 20 fractions) Phase 2

Detailed Description:

The standard treatment for most patients with biochemical recurrence after radical prostatectomy is salvage radiotherapy. Salvage radiotherapy delays the need for chronic, non-curative treatment, such as long-term androgen suppression, and is the only potentially curative treatment of some biochemical recurrences after prostatectomy.

Patients are recommended to undergo salvage radiotherapy to eradicate biochemical disease delivered in approximately 40 treatments over the course of 8 weeks, representing a high burden of therapy, which may be related to lower utilization of salvage radiotherapy. Modern radiotherapy for prostate cancer has been afforded many advantages including advanced image-guided radiotherapy allowing for larger dose delivery in fewer treatments and smaller margins with hypofractionated (20 treatments) and ultra-hypofractionated (5 treatments) radiotherapy.

In patients that need salvage radiotherapy, the potential advantages of hypofractionated and ultra-hypofractionated radiotherapy delivered over 20 or 5 treatments are: 1) increased convenience to patients because of fewer treatment days, 2) reduced costs to patients because of reduced travel expenses and copays, 3) improved resource utilization for physicians because of the fewer number of treatments per patient and consequently 4) reduced cost to society. In prostate cancer specifically, hypofractionated and ultra-hypofractionated radiotherapy has the added potential of not increasing toxicity with shorter treatment times.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of Salvage Radiotherapy for Prostate Cancer In 4 Weeks v. 2 Weeks
Actual Study Start Date : September 24, 2020
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: ARM 1 - 2 weeks
Patients will receive treatment to the prostate fossa +/- nodes in 32.5 Gy in 5 fractions. Patients receiving 32.5 Gy in 5 fractions cannot be treated on consecutive days.
 Radiation: 5 days Radiation Therapy (32.5 Gy in 5 fractions)
Patients will receive treatment to the prostate fossa +/- nodes in either 32.5 Gy in 5 fractions or 55 Gy in 20 fractions.
Active Comparator: ARM 2 - 4 weeks
Patients will receive treatment to the prostate fossa +/- nodes in 55 Gy in 20 fractions.
 Radiation: 20 days Radiation therapy (55 Gy in 20 fractions)
Patients will receive treatment to the prostate fossa +/- nodes in either 32.5 Gy in 5 fractions or 55 Gy in 20 fractions.


Outcome Measures
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Primary Outcome Measures :
  1. Change in the number of patient-reported GI symptoms using the Expanded Prostate Cancer Index Composite (EPIC) [ Time Frame: Baseline, 1 month, 24 months ]

    The primary objective is to demonstrate that 5 days of ultra-hypofractionated radiotherapy does not significantly increase patient-reported Gastrointestinal (GI) and Genitourinary (GU) symptoms over 20 days of hypofractionated radiotherapy 2 years after treatment completion as measured by EPIC.

    Expanded Prostate Cancer Index Composite (EPIC) short form questionnaire. The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes.



Secondary Outcome Measures :
  1. Change in the number of patient reported GI-GU symptoms at specific intervals as measured by Expanded Prostate Cancer Index Composite (EPIC) [ Time Frame: 3 months, 6 months, 12 months, 24 months, 60 months ]

    Secondary endpoints will include both the safety endpoints including change in GI and GU symptoms at 3, 6, 12, 24 and 60 months from end of treatment as measured by EPIC.

    Expanded Prostate Cancer Index Composite (EPIC) short form questionnaire. The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes.

    Adverse events can be unexpected or expected, related to treatment.


  2. Time to progression (TTP) [ Time Frame: 3 months, 6 months, 12 months, 24 months, 60 months ]
    Compare time to progression (TTP) where progression is defined as the first occurrence of biochemical failure (BF), local failure, regional failure, distant metastasis (DM), institution of new unplanned anticancer treatment, or death from prostate cancer (PCSM).

  3. Overall survival (OS) [ Time Frame: 3 months, 6 months, 12 months, 24 months, 60 months ]
    Overall survival (OS) will be measured among the participants

  4. Number of patients who expired due to prostate cancer. [ Time Frame: Through study completion, an average of 10 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men aged 18 and older with histologically confirmed prostate cancer after prostatectomy with detectable PSA. PSA does not need to be detectable for men with pathologically node positive disease.
  • KPS >=70
  • Patient with no evidence of distant metastatic disease on PET/CT/MRI or bone scan < 90 -180 days prior to enrollment. Patients with pelvic lymph nodes equivocal or questionable by imaging are eligible if the nodes are ≤ 1.5 cm in the short axis.
  • Ability to receive MRI-guided radiotherapy.
  • Equivocal evidence of metastatic disease outside the pelvis on standard imaging requires documented negative biopsy.
  • Ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire.

Exclusion Criteria:

  • Prior history of receiving pelvic radiotherapy.
  • Patient with inflammatory bowel disease.
  • Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of ultra-hypofractionated radiotherapy.
  • History of bladder neck or urethral stricture.
Contacts and Locations
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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): NCT04422132


Contacts
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Contact: Sharanya Chandrasekhar, M.S. 646-962-2196 shc2043@med.cornell.edu
Contact: Pragya Yadav, Ph.D. 646-962-2199 pry2003@med.cornell.edu

Locations
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United States, New York
Weill Cornell Medicine Recruiting
New York, New York, United States, 10065
Contact: Pragya Yadav, Ph.D.    646-962-2199    pry2003@med.cornell.edu   
Contact: Charles Ekeh, M.D.    646-962-2196    che4005@med.cornell.edu   
Principal Investigator: Himanshu Nagar, M.D.         
Sponsors and Collaborators
Weill Medical College of Cornell University
Viewray Inc.
Investigators
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Principal Investigator: Himanshu Nagar, M.D. Weill Medical College of Cornell University
More Information
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Additional Information:

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT04422132    
Other Study ID Numbers: 20-03021572
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: July 5, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases