SPORT High-Risk Trial Evaluating SABR in Prostate Cancer

NCT03253978 | Active Not Recruiting DMC

• 1 other identifier: 14190SJ-SS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Late toxicity of SABR

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

• Late patient-reported quality of life

  up to ten years post completion of SABR

• Rate of PSA failure

  up to ten years post completion of SABR

• Prostate cancer-specific survival

  up to ten years post completion of SABR

• Overall survival

  up to ten years post completion of SABR

Study Arms (2)

SABR to prostate / seminal vesicles with pelvic ENI

EXPERIMENTAL

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 and seminal vesicles only

ACTIVE COMPARATOR

36.25Gy / 5 fractions to prostate and seminal vesicles.

Radiation: Stereotatic Radiotherapy

Interventions

Stereotatic Radiotherapy RADIATION

SABR to prostate / seminal nodes

SABR to prostate / seminal vesicles with pelvic ENI; SABR to prostate and seminal vesicles only

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Men with newly diagnosed high-risk localized prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Belfast Health and Social Care Trust: lead

Study Sites (1)

Belfast Health and Social Care Trust

Belfast, Co. Antrim, BT9 7AB, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Suneil Jain, Dr

  Chief Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not applicable - no masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomised feasibility study

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: August 18, 2017
• Study Start: January 18, 2016
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)