Clinical Trials /

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

NCT04422132

Description:

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).

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT04422132

Trial Eligibility

Document

Title

  • Brief Title: Randomized Phase II Trial of Salvage Radiotherapy for Prostate Cancer In 4 Weeks v. 2 Weeks
  • Official Title: Randomized Phase II Trial of Salvage Radiotherapy for Prostate Cancer In 4 Weeks v. 2 Weeks

Clinical Trial IDs

  • ORG STUDY ID: 20-03021572
  • NCT ID: NCT04422132

Conditions

  • Prostate Cancer

Purpose

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).

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.

Trial Arms

NameTypeDescriptionInterventions
ARM 1 - 2 weeksActive ComparatorPatients 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.
    ARM 2 - 4 weeksActive ComparatorPatients will receive treatment to the prostate fossa +/- nodes in 55 Gy in 20 fractions.

      Eligibility Criteria

              Inclusion Criteria:

          -  Men aged 18 and older with histologically confirmed prostate cancer after
             prostatectomy with PSA of at least 0.1 ng/ml.

          -  Prostatectomy > 6 months before treatment

          -  KPS > 70

          -  Patient with no evidence of distant metastatic disease on CT/MRI and bone scan < 60
             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.
      Maximum Eligible Age:90 Years
      Minimum Eligible Age:18 Years
      Eligible Gender:Male
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Change in the number of patient-reported GI symptoms using the Expanded Prostate Cancer Index Composite (EPIC)
      Time Frame:Baseline, 1 month, 24 months
      Safety Issue:
      Description: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

      Measure: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
      Safety Issue:
      Description: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.
      Measure:Time to progression (TTP)
      Time Frame:3 months, 6 months, 12 months, 24 months, 60 months
      Safety Issue:
      Description: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).
      Measure:Overall survival (OS)
      Time Frame:3 months, 6 months, 12 months, 24 months, 60 months
      Safety Issue:
      Description:Overall survival (OS) will be measured among the participants
      Measure:Number of patients who expired due to prostate cancer.
      Time Frame:Through study completion, an average of 10 years
      Safety Issue:
      Description:

      Details

      Phase:Phase 2
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Weill Medical College of Cornell University

      Last Updated

      June 30, 2021