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FOcal Radiation for Oligometastatic Castration-rEsistant Prostate Cancer (FORCE)

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ClinicalTrials.gov Identifier: NCT03556904
Recruitment Status : Recruiting
First Posted : June 14, 2018
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Brief Summary:
This clinical trial will determine whether the addition of radiotherapy to standard of care first line systemic therapy improves objective progression-free survival rate (combined radiographic and clinical) at 18 months, compared to first line systemic therapy alone.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Radiation Therapy Drug: Enzalutamide Drug: Abiraterone Drug: Docetaxel Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: FOcal Radiation for Oligometastatic Castration-rEsistant Prostate Cancer (FORCE): A Phase II Randomized Trial
Actual Study Start Date : August 14, 2018
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : September 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Active Comparator: Standard of Care
The choice of agent will be up to the treating medical oncologist and is not the study intervention. Current first line systemic therapy is most commonly a second generation androgen pathway inhibitor, including enzalutamide or abiraterone, although docetaxel is allowed. Patients will begin systemic treatment within 3 weeks of randomization.
Drug: Enzalutamide
Current standard of care dosing

Drug: Abiraterone
Current standard of care dosing

Drug: Docetaxel
Current standard of care dosing

Experimental: Standard of Care + Radiotherapy

Standard of care therapy will be up to the treating medical oncologist and is not the study intervention. Current first line systemic therapy is most commonly a second generation androgen pathway inhibitor, including enzalutamide or abiraterone, although docetaxel is allowed.

Radiotherapy will be delivered to a total EQD2 (Equivalent dose in 2Gy fractions) that ranges between conventional 30 Gy in 10 fractions, to SBRT (Stereotactic Body Radiation Therapy) with 50 Gy in 5 fractions. Patients must start systemic therapy within 3 weeks of randomization (unless radiation is begun within 3 weeks and the provider may hold systemic therapy until completion of radiation) and receive radiotherapy within 8 weeks of randomization.

Radiation: Radiation Therapy
Radiotherapy will be delivered to a total EQD2 (Equivalent dose in 2Gy fractions) that ranges between conventional 30 Gy in 10 fractions, to SBRT with 50 Gy in 5 fractions. Patients must start systemic therapy within 3 weeks of randomization and receive radiotherapy within 8 weeks of randomization.

Drug: Enzalutamide
Current standard of care dosing

Drug: Abiraterone
Current standard of care dosing

Drug: Docetaxel
Current standard of care dosing




Primary Outcome Measures :
  1. The proportion of patients who are progression-free and alive at 18 months [ Time Frame: 18 Months ]

    The number of patients who are objective progression-free and alive at 18 months will be counted in each treatment arm and divided by the number of patients who received any protocol treatment to provide the 18-month objective PFS (progression free survival) proportion.

    Response and progression definitions used will be a combination of the criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee and the Prostate Cancer Working Group 3.

    For target/measurable disease progression will be defined as at least a 20% increase in the sum of the LD (longest diameter) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions. The sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new target lesions is also considered progression.



Secondary Outcome Measures :
  1. Median objective progression free survival time [ Time Frame: 24 months ]
    Objective progression-free survival (PFS) is defined as the duration of time from start of treatment to date that progression is objectively documented or death occurs (whichever is first).

  2. Median PSA progression free survival time [ Time Frame: Up to 24 months ]
    The Median PSA progression free survival time is defined as the median duration of time from start of treatment to date that PSA progression is documented or death occurs (whichever is first). PSA (prostate specific antigen) progression is defined as a 25% increase over baseline or nadir whichever is lower and an increase in the absolute value of PSA level by 2 ng/ml.

  3. Median radiographic progression free survival [ Time Frame: 24 months ]
    Radiographic progression-free survival (PFS) is defined as the duration of time from start of treatment to date that progression is radio-graphically documented or death occurs (whichever is first).

  4. Overall survival time [ Time Frame: 24 months ]
    Overall survival (OS) is defined as the duration of time from start of treatment to death.

  5. Prostate cancer specific survival time [ Time Frame: 24 months ]
    Prostate Cancer Specific Survival (PCSS) is defined as the duration of time from start of treatment to death from prostate cancer.

  6. Non-irradiated metastases free survival time [ Time Frame: 24 months ]
    Non-irradiated metastases free survival is defined as the duration of time from start of treatment to the date of progressive disease of a new target lesion, a new non-measurable/non-target lesion or emergence of 2 or more new skeletal lesions on a bone scan.

  7. The proportion of patients with complete PSA response [ Time Frame: Up to 24 months ]
    The number of patients whose PSA becomes undetectable (≤0.2 ng/ml) will be counted in each treatment arm and divided by the number of patients who received any protocol treatment to provide the proportion of patients with complete PSA response. Complete PSA response is defined as an undetectable PSA (≤0.2 ng/ml).

  8. The proportion of patients with a PSA Partial Response 50 (PR50) [ Time Frame: Up to 24 months ]
    The number of patients whose PSA declines by 50% decline (PSA partial response 50 (PR50)) will be counted in each treatment arm and divided by the number of patients who received any protocol treatment to provide the proportion of patients with PR50. PR50 response is defined as a decrease in PSA value by ≥ 50%.

  9. The proportion of patients with a PSA Partial Response 90 (PR90) [ Time Frame: Up to 24 months ]
    The number of patients whose PSA declines by 90% decline (PSA partial response 90 (PR90)) will be counted in each treatment arm and divided by the number of patients who received any protocol treatment to provide the proportion of patients with PR90. PR90 response is defined as a decrease in PSA value by ≥ 90%.

  10. The proportion of patients that respond to treatment [ Time Frame: 24 months ]

    The measurable disease response rate (CR + PR) will be calculated for patients evaluable for measurable disease response.

    Complete response (CR) is defined as a disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduced in short axis to <10 mm. There can be no appearance of new lesions.

    Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. There can be no appearance of new lesions.




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

Inclusion Criteria:

  • Subjects must have biopsy-confirmed adenocarcinoma of the prostate
  • Patients must discontinue all systemic or experimental therapies for at least 2 weeks prior to registration with no evidence of a falling PSA (prostate specific antigen) after washout. LHRH (luteinizing hormone-releasing hormone) analogues must be continued if they have not undergone orchiectomy.
  • Subjects must have progressive metastatic castration-resistant prostate cancer based on at least one of the following criteria while having castrate levels (<50 ng/dL) of testosterone:
  • A) PSA progression defined as a 25% increase over baseline value with an increase in the absolute value of at least 2.0 ng/mL that is confirmed by another PSA level with a minimum of a 1-week interval.
  • B) Progression of bidimensionally measurable soft tissue or nodal metastasis by CT scan or MRI based on RECIST criteria
  • C) Progression of bone disease on bone scan as defined by two new lesions arising
  • Subjects must have oligometastatic prostate cancer, defined as between 1 and ≤5 treatment sites that can be treated within a radiotherapy treatment field.
  • Subjects must be medically fit to undergo radiotherapy and first line systemic therapy as determined by the treating physician.
  • Age ≥ 18
  • ECOG ≤ 2 (Eastern Cooperative Oncology Group scoring system used to quantify general well-being and activities of daily life; scores range from 0 to 5 where 0 represents perfect health and 5 represents death)
  • No prior invasive malignancy in the past 3-years unless disease free for a minimum of 2 years. Exceptions include non-melanomatous skin cancer and in situ cancers of the bladder or head and neck are permissible.
  • Subjects must freely sign informed consent to enroll in the study.

Exclusion Criteria:

  • Planned first line systemic therapy with Radium-223 dichloride or sipuleucel-T
  • Life expectancy estimate of <3 months
  • Presence of known parenchymal brain metastasis
  • Uncontrolled intercurrent illness
  • Inability to undergo radiotherapy, systemic treatment, CTs or bone scans
  • Biopsy proven pure small cell or neuroendocrine prostate cancer

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): NCT03556904


Contacts
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Contact: Zachery Reichert, MD, PhD (734)-764-3066 zreiche@med.umich.edu

Locations
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United States, Michigan
University of Michigan Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Zachery Reichert, MD, PhD    734-764-3066    zreiche@med.umich.edu   
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
Investigators
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Principal Investigator: Zachery Reichert, MD, PhD University of Michigan Rogel Cancer Center

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Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT03556904     History of Changes
Other Study ID Numbers: UMCC 2017.163
HUM00138918 ( Other Identifier: University of Michigan )
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
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
Prostatic Diseases
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action