Clinical Trials /

Radiation Therapy (Hypofractionated Proton Beam Therapy or IMRT) for the Treatment of Recurrent, Oligometastatic Prostate Cancer Following Primary Localized Treatment

NCT04190446

Description:

This phase II trial studies the side effects of radiation therapy (hypofractionated proton beam therapy or IMRT) for the treatment of prostate cancer that has come back (recurrent) or that has spread to a limited number of sites (oligometastatic) following primary localized treatment. Hypofractionated proton beam radiation therapy delivers smaller doses of radiation therapy over time and may kill more tumor cells and have fewer side effects. IMRT uses high energy x-rays to kill tumor cells and shrink tumors. This trial is being done to find out if a shorter course of radiation therapy is better with fewer side effects for patients with recurrent prostate cancer.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT04190446

Trial Eligibility

Document

Title

  • Brief Title: Radiation Therapy (Hypofractionated Proton Beam Therapy or IMRT) for the Treatment of Recurrent, Oligometastatic Prostate Cancer Following Primary Localized Treatment
  • Official Title: A Randomized, Parallel Phase II Trial of Hypofractionated Proton Therapy or IMRT for Recurrent, Oligometastatic Prostate Cancer Involving Only Pelvic and/or Para-Aortic Lymph Nodes Following Primary Localized Treatment

Clinical Trial IDs

  • ORG STUDY ID: MC1851
  • SECONDARY ID: NCI-2019-07705
  • SECONDARY ID: MC1851
  • SECONDARY ID: P30CA015083
  • NCT ID: NCT04190446

Conditions

  • Metastatic Prostate Adenocarcinoma
  • Oligometastatic Prostate Carcinoma
  • Prostate Adenocarcinoma
  • Recurrent Prostate Carcinoma
  • Stage IV Prostate Cancer AJCC v8
  • Stage IVA Prostate Cancer AJCC v8
  • Stage IVB Prostate Cancer AJCC v8

Purpose

This phase II trial studies the side effects of radiation therapy (hypofractionated proton beam therapy or IMRT) for the treatment of prostate cancer that has come back (recurrent) or that has spread to a limited number of sites (oligometastatic) following primary localized treatment. Hypofractionated proton beam radiation therapy delivers smaller doses of radiation therapy over time and may kill more tumor cells and have fewer side effects. IMRT uses high energy x-rays to kill tumor cells and shrink tumors. This trial is being done to find out if a shorter course of radiation therapy is better with fewer side effects for patients with recurrent prostate cancer.

Detailed Description

      PRIMARY OBJECTIVE:

      I. To assess late >= grade 3 gastrointestinal (GI) and/or genitourinary (GU) toxicity of
      interest with the hypofractionated regimen with proton beam therapy or intensity-modulated
      radiation therapy (IMRT) (late defined as 3 to 24 months after protocol radiation therapy
      [RT]).

      SECONDARY OBJECTIVES:

      I. Late grade >= 2 GI and/or GU toxicities of interest within 24 months after the protocol
      RT, using the Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0.

      II. Acute grade >= 3 GI and/or GU toxicities of interest during and within 3 months after the
      protocol RT, using the CTCAE v4.0.

      III. Compare the rates of late >= grade 3 GI and/or GU toxicity between the 2 treatment
      schedules.

      OUTLINE: Patients are randomized to 1 of 2 arms.

      ARM I: Patients undergo proton beam radiation therapy 5 days a week over 3 weeks.

      ARM II: Patients undergo IMRT 5 days a week over 5 weeks.

      After completion of study, patients are followed up at 3-6, 12, 18, 24, 30, 36, 42, 48, 54,
      and 60 months.

Trial Arms

NameTypeDescriptionInterventions
Arm I (proton beam radiation therapy)ExperimentalPatients undergo proton beam radiation therapy 5 days a week over 3 weeks.
    Arm II (IMRT)ExperimentalPatients undergo IMRT 5 days a week over 5 weeks.

      Eligibility Criteria

              Inclusion Criteria:

          -  Histological confirmation of prostate adenocarcinoma

          -  Recurrent prostate cancer after prior receipt of primary radiotherapy to the prostate
             (can also include treatment of splenic vessels [SVs] and lymph nodes [LNs]) or salvage
             RT to the prostate fossa (can also include prior pelvic RT)

          -  Oligometastatic extent of disease

               -  Recurrent disease involving lymph nodes as diagnosed with choline positron
                  emission tomography (PET)/computed tomography (CT) or other advanced PET imaging
                  (prostate-specific membrane antigen [PSMA] or flucyclovine)

               -  Limited to pelvic and/or retroperitoneal/para-aortic lymph nodes

          -  Zubrod performance score (PS) =< 1

          -  Signed informed consent

        Exclusion Criteria:

          -  Bone or visceral metastases present

          -  Lymph node metastases beyond the pelvis and/or retroperitoneum

          -  Contraindications to RT (e.g., uncontrolled inflammatory bowel disease)

          -  Contraindications to androgen suppression

          -  Concurrent antineoplastic agents (chemotherapy)

          -  Previous or concurrent malignancy other than non-melanoma skin cancer within 5 years
             of diagnosis of prostate cancer

          -  Inability to start the protocol treatment within 6 months after study enrollment

          -  Medical or psychiatric conditions that preclude informed decision-making or compliance
             with the protocol treatment or follow-up
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:Male
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Proportion of patients who experience a late (>= 90 days after radiation therapy [RT] start date) grade 3 or higher gastrointestinal (GI) and/or genitourinary (GU) adverse event (AE)
      Time Frame:Up to 24 months after RT
      Safety Issue:
      Description:Toxicity will be defined as an adverse event possibly, probably, or definitely related to proton beam therapy. The proportion of grade 3 or higher GI or GU toxicities will be estimated by the number of patients with a late grade 3 or higher GI or GU toxicity divided by the total number of evaluable patients. Exact binomial 90% confidence intervals for the toxicity proportion will be calculated.

      Secondary Outcome Measures

      Measure:Incidence of acute adverse events
      Time Frame:Up to 3 months after the completion of RT
      Safety Issue:
      Description:The rate of >= grade 3 GI or GU acute adverse events will be estimated by the number of patients with a >= grade 3 GI or GU acute adverse event divided by the total number of evaluable patients. Exact binomial 90% confidence intervals for the true rate of >= grade 3 GI or GU acute adverse events will be calculated.
      Measure:Incidence of late adverse events
      Time Frame:Between 3 months and 2 years after completion of proton beam therapy
      Safety Issue:
      Description:The rate of >= grade 2 GI or GU late adverse events will be estimated by the number of patients with a >= grade 2 GI or GU late adverse event divided by the total number of evaluable patients. Exact binomial 90% confidence intervals for the true rate of >= grade 2 GI or GU late adverse events will be calculated.
      Measure:Proportion of grade 3 or higher GI or GU adverse events
      Time Frame:Up to 60 months
      Safety Issue:
      Description:The difference between the 2 treatment arm proportions will be determined and exact binomial 90% confidence intervals for the difference in grade 3 or higher GI or GU toxicity rates will be calculated.
      Measure:Incidence of adverse events
      Time Frame:Up to 60 months
      Safety Issue:
      Description:All eligible patients that have initiated treatment will be considered evaluable for assessing adverse event rate(s). The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. Acute and late adverse events will be summarized separately.

      Details

      Phase:Phase 2
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Mayo Clinic

      Last Updated

      March 15, 2021