5 Fractions of Pelvic SABR With Intra Prostatic SABR Boost:

Prostate Cancer Clinical Trial

— 5STAR-PC  

Official title:

5 Fractions of Pelvic SABR With Intra Prostatic SABR Boost:A Phase II Study (5STAR-PC)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04245670
• Other study ID #: 5STAR-PC
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 31, 2018
• Est. completion date: January 31, 2025

Study information

• Verified date: September 2022
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: January 31, 2025
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Center	Toronto	Ontairo

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Prostate Cure Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Quality of Life outcome	Measuring quality of life using Expanded Prostate Index Composite (EPIC)	Baseline to end of 5 year follow up
Secondary	Biochemical disease-free survival	Biochemical disease-free survival	Baseline to end of 5 year follow up
Secondary	Quality of life outcome	Health utilities using the EQ-5D Quality of Life Questionnaire tool	Baseline to end of 5 year follow up
Secondary	Quality of life outcome	Health utilities using PORPUS-U Quality of Life Questionnaire tool	Baseline to end of 5 year follow up
Secondary	Economic analysis	Cost effectiveness of treatment.Quality of life and cost estimates will be captured for each patient from time of the initiation of treatment until death. The effectiveness endpoints will be biochemical disease free survival and quality-adjusted life years (QALYs). QALY will be calculated by survival (in years) multiplied by a utility weight associated with a certain condition.	Baseline to end of 5 year follow up