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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Radiation: Stereotatic Radiotherapy

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Suneil Jain, Dr; Phone Number: 028 90638468; Email: NICTN@belfasttrust.hscni.net
• Study Contact Backup: Name: Joe O'Sullivan, Prof; Phone Number: 028 90638468; Email: NICTN@belfasttrust.hscni.net

Study Locations

• United Kingdom
  • Co. Antrim
    • Belfast, Co. Antrim, United Kingdom, BT9 7AB
      • Belfast Health and Social Care Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adequate recruitment rate	adequate recruitment rate (30 patients in 24 months)	24 months
Acute toxicity of SABR	Acute toxicity of SABR (as assessed by CTCAE v4.03 scores until 90 days of completion of SABR)	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)	90 days after completion of SABR
Number of SABR plans delivered as planned and on schedule	Number of SABR plans delivered as planned and on schedule	29 days (treatment period)
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)	until 90 days post completion of radiotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	from 90 days and up 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)	up to ten years post completion of SABR
Rate of PSA failure	Rate of PSA failure as assessed by Phoenix criteria	up to ten years post completion of SABR
Prostate cancer-specific survival	Prostate cancer-specific survival	up to ten years post completion of SABR
Overall survival	Overall survival	up to ten years post completion of SABR

Collaborators and Investigators

• Sponsor: Belfast Health and Social Care Trust
• Investigators: Principal Investigator: Suneil Jain, Dr, Chief Investigator

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2016
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: August 16, 2017
• First Submitted That Met QC Criteria: August 16, 2017
• First Posted (Actual): August 18, 2017

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 14190SJ-SS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We would welcome collaboration with other researchers as long as full ethical approval was granted

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No