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SPORT High-Risk Trial Evaluating SABR in Prostate Cancer (SPORT)

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: NCT03253978
Recruitment Status : Recruiting
First Posted : August 18, 2017
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Belfast Health and Social Care Trust

Brief Summary:
The study will examine stereotactic ablative body radiotherapy (SABR), a new technique to deliver radiotherapy to men with prostate cancer. In addition to this, it will look at the effect of SABR on levels of markers of radiation exposure and bowel damage, along with other potential markers of outcome and side effects. Quality of life and any side effects that develop during and after treatment will also be assessed.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Stereotatic Radiotherapy Not Applicable

Detailed Description:

The study will examine stereotactic ablative body radiotherapy (SABR), a new technique to deliver radiotherapy to men with prostate cancer. In addition to this, it will look at the effect of SABR on levels of markers of radiation exposure and bowel damage, along with other potential markers of outcome and side effects. Quality of life and any side effects that develop during and after treatment will also be assessed.

Participants will be treated with five treatments (instead of the standard 37). This is more convenient for them and also allows the treatment of many more people in the same time frame, which should improve the timely delivery of radiotherapy for all patients.

Thirty men with high-risk prostate cancer will be enrolled into the study. They will all be treated with hormone therapy and radiotherapy to the prostate and seminal vesicles. In addition, half of the men will receive an additional dose of radiation to their pelvis. Gold markers will be placed in the prostate before radiotherapy to allow precise targeting of the prostate during treatment. CT scans are taken before and after each treatment to ensure the accuracy of its delivery.

Blood urine and prostate tissue samples will be taken before, during and after radiotherapy. Side effects and quality of life will also by assessed during this time.

Ultimately, this may allow us to predict which men are at increased risk of side effects from radiotherapy and allow closer monitoring, earlier intervention and perhaps alternative treatments in some cases. This should improve the control of prostate cancer and reduce the risk of serious treatment-related side effects

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: A randomised feasibility study
Masking: None (Open Label)
Masking Description: Not applicable - no masking
Primary Purpose: Treatment
Official Title: A Randomised Feasibility Study Evaluating Stereotactic Prostate Radiotherapy In High-Risk Localised Prostate Cancer With or Without Elective Nodal Irradiation
Actual Study Start Date : January 18, 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: SABR to prostate / seminal vesicles with pelvic ENI
36.25Gy / 5 fractions to prostate and seminal vesicles with additional SABR (25Gy /5 fractions) delivered to the pelvic nodes.
Radiation: Stereotatic Radiotherapy
SABR to prostate / seminal nodes

Active Comparator: SABR to prostate and seminal vesicles only
36.25Gy / 5 fractions to prostate and seminal vesicles.
Radiation: Stereotatic Radiotherapy
SABR to prostate / seminal nodes




Primary Outcome Measures :
  1. Adequate recruitment rate [ Time Frame: 24 months ]
    adequate recruitment rate (30 patients in 24 months)

  2. Acute toxicity of SABR [ Time Frame: 90 days of completion of SABR ]
    Acute toxicity of SABR (as assessed by CTCAE v4.03 scores until 90 days of completion of SABR)

  3. Acute quality of life during and after SABR [ Time Frame: 90 days after completion of SABR ]
    Acute quality of life during and after SABR (as assessed by EPIC and IPSS scores until 90 days after completion of SABR)

  4. Number of SABR plans delivered as planned and on schedule [ Time Frame: 29 days (treatment period) ]
    Number of SABR plans delivered as planned and on schedule

  5. Quantification of acute toxicity in each treatment group [ Time Frame: until 90 days post completion of radiotherapy ]
    Quantification of acute toxicity in each treatment group to enable calculation of the sample size for the Phase II RCT (using CTCAE v4.03 scores measured until 90days post completion of radiotherapy)


Secondary Outcome Measures :
  1. Late toxicity of SABR [ Time Frame: from 90 days and up to ten years post completion of SABR ]
    Late toxicity of SABR (as assessed by GI and GU RTOG late toxicity scores from 90 days to ten years post completion of SABR)

  2. Late patient-reported quality of life [ Time Frame: up to ten years post completion of SABR ]
    Late patient-reported quality of life (as assessed by EPIC and IPSS scores from 90 days to ten years post completion of SABR)

  3. Rate of PSA failure [ Time Frame: up to ten years post completion of SABR ]
    Rate of PSA failure as assessed by Phoenix criteria

  4. Prostate cancer-specific survival [ Time Frame: up to ten years post completion of SABR ]
    Prostate cancer-specific survival

  5. Overall survival [ Time Frame: up to ten years post completion of SABR ]
    Overall survival



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Men with newly diagnosed high-risk localized prostate cancer
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients with histologically confirmed prostate adenocarcinoma who elect for radical radiotherapy, with at least one of the following features:

  • clinical stage T3a N0 M0
  • Gleason score 7 (4+3) or above
  • PSA > 20

No evidence of nodal or distant metastatic disease

WHO performance status 0-2

Life expectancy of at least 5 years

Men greater than or equal to 18 years

Ability to understand and willingness to sign a written informed consent document (completed prior to registration and subsequent randomization), along with willingness to co-operate with follow-up

Planned to receive 12-36 months of ADT as part of standard treatment

Exclusion Criteria:

T stage greater than or equal to T3b / T4

Prostate volume > 90cc

Current evidence of:

  • inflammatory bowel disease or other chronic bowel disorder
  • Autoimmune disease
  • Active uncontrolled bacterial, viral or fungal infection
  • Serious uncontrolled concomitant disease
  • Known coagulopathy or bleeding diasthesis
  • Anticoagulation medication (if unsafe to insert for seed insertion)
  • Bilateral hip prosthesis or fixation which would interfere with standard radiation beam configuration
  • Concurrent experimental or cytotoxic drugs
  • Allergy to gold
  • Severe lower urinary tract symptoms - International Prostate Symptom Score (IPSS) > 19
  • Any other contra-indication to hormonal therapy or radical radiotherapy.

History of:

  • Previous major abdominal surgery or history of bowel adhesions
  • Prior pelvic radiotherapy
  • Active malignancy within the preceding five years (other than basal cell carcinoma)

Evidence of:

- Castrate-resistance (rising PSA with castrate levels of testosterone on LHRHa and anti-androgen)


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): NCT03253978


Contacts
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Contact: Suneil Jain, Dr 028 90638468 nictn@belfasttrust.hscni.net
Contact: Joe O'Sullivan, Prof 028 90638468 nictn@belfasttrust.hscni.net

Locations
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United Kingdom
Belfast Health and Social Care Trust Recruiting
Belfast, Co. Antrim, United Kingdom, BT9 7AB
Contact: Suneil Jain, Dr    028 90638468    NICTN@belfasttrust.hscni.net   
Contact: Joe O'Sullivan, Prof    028 90638468    NICTN@belfasttrust.hscni.net   
Principal Investigator: Suneil Jain, Dr         
Sub-Investigator: Joe O'Sullivan, Prof         
Sub-Investigator: Darren Mitchell, Dr         
Sub-Investigator: Ciara Lyons, Dr         
Sub-Investigator: Ciaran Fairmichael, Dr         
Sponsors and Collaborators
Belfast Health and Social Care Trust
Investigators
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Principal Investigator: Suneil Jain, Dr Chief Investigator

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Responsible Party: Belfast Health and Social Care Trust
ClinicalTrials.gov Identifier: NCT03253978    
Other Study ID Numbers: 14190SJ-SS
First Posted: August 18, 2017    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We would welcome collaboration with other researchers as long as full ethical approval was granted

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