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

Primary Purpose

Prostate Cancer

Status

Active

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Stereotatic Radiotherapy

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

Belfast Health and Social Care Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SABR to prostate / seminal vesicles with pelvic ENI

SABR to prostate and seminal vesicles only

Arm Description

36.25Gy / 5 fractions to prostate and seminal vesicles with additional SABR (25Gy /5 fractions) delivered to the pelvic nodes.

36.25Gy / 5 fractions to prostate and seminal vesicles.

Outcomes

Primary Outcome Measures

Adequate recruitment rate

adequate recruitment rate (30 patients in 24 months)

Acute toxicity of SABR

Acute toxicity of SABR (as assessed by CTCAE v4.03 scores until 90 days of completion of SABR)

Acute quality of life during and after SABR

Acute quality of life during and after SABR (as assessed by EPIC and IPSS scores until 90 days after completion of SABR)

Number of SABR plans delivered as planned and on schedule

Quantification of acute toxicity in each treatment group

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

Late toxicity 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)

Late patient-reported quality of life

Late patient-reported quality of life (as assessed by EPIC and IPSS scores from 90 days to ten years post completion of SABR)

Rate of PSA failure

Rate of PSA failure as assessed by Phoenix criteria

Prostate cancer-specific survival

Overall survival

Full Information

NCT ID

NCT03253978

First Posted

August 16, 2017

Last Updated

September 6, 2023

Sponsor

Belfast Health and Social Care Trust

1. Study Identification

Unique Protocol Identification Number

NCT03253978

Brief Title

SPORT High-Risk Trial Evaluating SABR in Prostate Cancer

Acronym

SPORT

Official Title

A Randomised Feasibility Study Evaluating Stereotactic Prostate Radiotherapy In High-Risk Localised Prostate Cancer With or Without Elective Nodal Irradiation

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 18, 2016 (Actual)

Primary Completion Date

April 30, 2026 (Anticipated)

Study Completion Date

April 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Belfast Health and Social Care Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

A randomised feasibility study

Masking

None (Open Label)

Masking Description

Not applicable - no masking

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SABR to prostate / seminal vesicles with pelvic ENI

Arm Type

Experimental

Arm Description

36.25Gy / 5 fractions to prostate and seminal vesicles with additional SABR (25Gy /5 fractions) delivered to the pelvic nodes.

Arm Title

SABR to prostate and seminal vesicles only

Arm Type

Active Comparator

Arm Description

36.25Gy / 5 fractions to prostate and seminal vesicles.

Intervention Type

Radiation

Intervention Name(s)

Stereotatic Radiotherapy

Intervention Description

SABR to prostate / seminal nodes

Primary Outcome Measure Information:

Title

Adequate recruitment rate

Description

adequate recruitment rate (30 patients in 24 months)

Time Frame

24 months

Title

Acute toxicity of SABR

Description

Acute toxicity of SABR (as assessed by CTCAE v4.03 scores until 90 days of completion of SABR)

Time Frame

90 days of completion of SABR

Title

Acute quality of life during and after SABR

Description

Acute quality of life during and after SABR (as assessed by EPIC and IPSS scores until 90 days after completion of SABR)

Time Frame

90 days after completion of SABR

Title

Number of SABR plans delivered as planned and on schedule

Description

Number of SABR plans delivered as planned and on schedule

Time Frame

29 days (treatment period)

Title

Quantification of acute toxicity in each treatment group

Description

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)

Time Frame

until 90 days post completion of radiotherapy

Secondary Outcome Measure Information:

Title

Late toxicity of SABR

Description

Late toxicity of SABR (as assessed by GI and GU RTOG late toxicity scores from 90 days to ten years post completion of SABR)

Time Frame

from 90 days and up to ten years post completion of SABR

Title

Late patient-reported quality of life

Description

Late patient-reported quality of life (as assessed by EPIC and IPSS scores from 90 days to ten years post completion of SABR)

Time Frame

up to ten years post completion of SABR

Title

Rate of PSA failure

Description

Rate of PSA failure as assessed by Phoenix criteria

Time Frame

up to ten years post completion of SABR

Title

Prostate cancer-specific survival

Description

Prostate cancer-specific survival

Time Frame

up to ten years post completion of SABR

Title

Overall survival

Description

Overall survival

Time Frame

up to ten years post completion of SABR

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Men with newly diagnosed high-risk localized prostate cancer

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Suneil Jain, Dr

Organizational Affiliation

Chief Investigator

Official's Role

Principal Investigator

Facility Information:

Facility Name

Belfast Health and Social Care Trust

City

Belfast

State/Province

Co. Antrim

ZIP/Postal Code

BT9 7AB

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

We would welcome collaboration with other researchers as long as full ethical approval was granted

Learn more about this trial

SPORT High-Risk Trial Evaluating SABR in Prostate Cancer

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