5 Fractions of Pelvic SABR With Intra Prostatic SABR Boost:

NCT04245670 | Unknown DMC

• 1 other identifier: 5STAR-PC
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Stereotactic Ablative Body Radiotherapy (SABR) given in 5 weekly fractions. Simultaneously treating the pelvic lymph nodes, prostate and MRI-nodule to a total dose of 25 Gy, 35 Gy and up to 50 Gy, respectively. The radiation will be given with 6-18 months of ADT. 5-fraction SABR is a feasible, well-tolerated, effective and cost effective treatment for high-intermediate and high risk prostate cancer with/without an image-guided intraprostatic boost.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Acute Toxicity

  To document the acute urinary toxicity using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) criteria

  Baseline to 3 months post completion of treatment

• Acute Toxicity

  To document the acute bowel toxicity using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) criteria

  Baseline to 3 months post completion of treatment

Secondary Outcomes (5)

• Quality of Life outcome

  Baseline to end of 5 year follow up

• Biochemical disease-free survival

  Baseline to end of 5 year follow up

• Quality of life outcome

  Baseline to end of 5 year follow up

• Quality of life outcome

  Baseline to end of 5 year follow up

• Economic analysis

  Baseline to end of 5 year follow up

Study Arms (1)

Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5

EXPERIMENTAL

Stereotactic Ablative Body Radiotherapy (SABR) given in 5 weekly fractions. Simultaneously treating the pelvic lymph nodes, prostate and MRI-nodule to a total dose of 25 Gy, 35 Gy and up to 50 Gy, respectively. The radiation will be given with 6-18 months of ADT.

Radiation: Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5

Interventions

Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5 RADIATION

Stereotactic Ablative Body Radiotherapy (SABR) given in 5 weekly fractions. Simultaneously treating the pelvic lymph nodes, prostate and MRI-nodule to a total dose of 25 Gy, 35 Gy and up to 50 Gy, respectively. The radiation will be given with 6-18 months of ADT.

Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male patients with Prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed prostate adenocarcinoma (centrally reviewed)
• High-intermediate risk defined as two or more of: T2c, Gleason 7 OR PSA 10-20ng/ml,
• High-risk prostate cancer, defined as at least one of: T3, Gleason 8-10, OR PSA \> 20 ng/mL
• Willing to give informed consent to participate in this clinical trial
• Able and willing to complete EPIC, PORPUS and EQ-5D questionnaires

You may not qualify if:

• Prior pelvic radiotherapy
• Contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
• Anticoagulation medication (if unsafe to discontinue for fiducial insertion)
• Diagnosis of bleeding diathesis
• Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) \>20
• Evidence of castrate resistance (defined as PSA \< 3 ng/ml while testosterone is \< 0.7nmol/l. Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression.
• Definitive extrapelvic nodal or distant metastatic disease on staging investigations.
• Hip prosthesis

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Prostate Cure Foundation: collaborator

Study Sites (1)

Sunnybrook Health Sciences Center

Toronto, Ontairo, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Andrew Loblaw, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 29, 2020
• Study Start: May 31, 2018
• Primary Completion: August 30, 2021
• Study Completion: January 31, 2025
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Analysis of acute toxicity will be performed approximately 6 months after the last patient has been accrued, in August 2020. The final analysis will be performed when all patients have completed 5 years of follow-up, in early 2025.
• Access Criteria: The primary endpoint analysis will be shared thru publications

Locations

CA (1)