5 Fractions of Pelvic SABR With Intra Prostatic SABR Boost: (5STAR-PC)
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ClinicalTrials.gov Identifier: NCT04245670 |
Recruitment Status :
Recruiting
First Posted : January 29, 2020
Last Update Posted : January 29, 2020
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prostate Cancer | Radiation: Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5 | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 75 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 5 Fractions of Pelvic SABR With Intra Prostatic SABR Boost:A Phase II Study (5STAR-PC) |
Actual Study Start Date : | May 31, 2018 |
Estimated Primary Completion Date : | August 30, 2020 |
Estimated Study Completion Date : | January 31, 2025 |

Arm | Intervention/treatment |
---|---|
Experimental: 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.
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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. |
- Acute Toxicity [ Time Frame: Baseline to 3 months post completion of treatment ]To document the acute urinary toxicity using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) criteria
- Acute Toxicity [ Time Frame: Baseline to 3 months post completion of treatment ]To document the acute bowel toxicity using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) criteria
- Quality of Life outcome [ Time Frame: Baseline to end of 5 year follow up ]Measuring quality of life using Expanded Prostate Index Composite (EPIC)
- Biochemical disease-free survival [ Time Frame: Baseline to end of 5 year follow up ]Biochemical disease-free survival
- Quality of life outcome [ Time Frame: Baseline to end of 5 year follow up ]Health utilities using the EQ-5D Quality of Life Questionnaire tool
- Quality of life outcome [ Time Frame: Baseline to end of 5 year follow up ]Health utilities using PORPUS-U Quality of Life Questionnaire tool
- Economic analysis [ Time Frame: Baseline to end of 5 year follow up ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Male patients with Prostate cancer |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04245670
Contact: Andrew Loblaw, MD | 416-480-5000 ext 4806 | andrew.loblaw@sunnybrook.ca | |
Contact: Andrea DeAbreu | 416-480-5000 ext 1058 | andrea.deabreu@sunnybrook.ca |
Canada, Ontairo | |
Sunnybrook Health Sciences Center | Recruiting |
Toronto, Ontairo, Canada, M4N 3M5 | |
Contact: Andrea DeAbreu 416-480-5000 ext 1058 andrea.deabreu@sunnybrook.ca | |
Principal Investigator: Andrew Loblaw, MD | |
Sub-Investigator: Gerard Morton, MD | |
Sub-Investigator: Patrick Cheung, MD | |
Sub-Investigator: William Chu, MD | |
Sub-Investigator: Danny Vesprini, MD | |
Sub-Investigator: Melanie Davidson, MD | |
Sub-Investigator: Rene Korol, MD | |
Sub-Investigator: Ananth Ravi, MD | |
Sub-Investigator: Stanley Liu, MD | |
Sub-Investigator: Eric Tseng, MD |
Principal Investigator: | Andrew Loblaw, MD | Sunnybrook Health Sciences Centre |
Responsible Party: | Sunnybrook Health Sciences Centre |
ClinicalTrials.gov Identifier: | NCT04245670 |
Other Study ID Numbers: |
5STAR-PC |
First Posted: | January 29, 2020 Key Record Dates |
Last Update Posted: | January 29, 2020 |
Last Verified: | January 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Supporting Materials: |
Clinical Study Report (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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |