An interventional study of Prostate radical radiotherapy and Prostate radical radiotherapy in Intermediate Risk Prostate Cancer (Diagnosis) and Prostate Cancer, sponsored by Sunnybrook Health Sciences Centre. Active, not recruiting at 1 site in Canada. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Treatment
DESTINATION 2 is a multi-centre randomised trial treating intermediate risk localised prostate cancer with 2 fraction Stereotactic Body Radiotherapy (SBRT). All radiotherapy will be delivered in two fractions (sessions) on an MR Linac using daily adaptation. Men will either receive uniform dose radiotherapy or de-escalated dose radiotherapy. The primary endpoint is acute GU CTCAE v5 grade 2+ toxicity. It will also look at late toxicity, patient-reported outcome measures and PSA control.
24 patients meeting inclusion criteria will be randomised between two arms. Arm 1 (Uniform dose) will receive 27 Gy in 2 fractions to the whole prostate + seminal vesicles (SV), the CTV, with 0 mm CTV-PTV margin. Arm 2 (De-escalated dose) will use two dose levels: The benign prostate (on MRI) will receive 20 Gy in 2 fractions with a 0mm PTV margin. The intraprostatic tumour mass(es) as seen on MRI will receive 27 Gy in 2 fractions. A 4mm GTV-PTV margin will be added to the MR visible tumour to form PTV 27Gy. The primary endpoint is emergent acute GU CTCAE v5 Grade 2+ toxicity, recorded within 3 months of completing radiotherapy. Secondary endpoints are CT CAE v5 acute GI toxicity, late toxicity, patient-reported outcome measures (PROMs) (EPIC-26, IPSS, and IIEF-5) at 4 and 12 weeks, 6 months, 1 and 2 years post treatment, PSA control and kinetics
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Exclusion Criteria:
Arm 1 (Uniform dose) will receive 27 Gy in 2 fractions to the whole prostate + seminal vesicles (SV), the CTV, with 0 mm CTV-PTV margin.
Radiation: Prostate radical radiotherapy
Arm 2 (De-escalated dose) will use two dose levels: The benign prostate (on MRI) will receive 20 Gy in 2 fractions with a 0mm PTV margin. The intraprostatic tumour mass(es) as seen on MRI will receive 27 Gy in 2 fractions. A 4mm GTV-PTV margin will be added to the MR visible tumour to form PTV 27Gy.
Radiation: Prostate radical radiotherapy
All radiotherapy will be delivered in two fractions (sessions) on an MR Linac using daily adaptation.
All radiotherapy will be delivered in two fractions (sessions) on an MR Linac using daily adaptation
Acute GU toxicity
To describe the absolute risk and relative risk reduction of acute genitourinary (GU) toxicity (CTCAE v5) when delivering de-escalated two fraction prostate SBRT compared to uniform dose two fraction prostate stereotactic body radiotherapy (SBRT) for intermediate risk prostate cancer.
Time frame: 12 weeks
Acute Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) toxicity
To describe the absolute and relative risk of toxicity
Time frame: Baseline, at completion of radiotherapy, Week 2, Week 4, and Week 12
Late Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) toxicity
To describe the absolute and relative risk of toxicity
Time frame: Month 6, 12, 24
Feasibility of radiation delivery
Feasibility- estimate percentage of fractions interrupted due to patient discomfort
Time frame: During each treatment fraction
Dosimetry
Dosimetry- estimate the accumulated dose differences between the de-escalated and uniform dose delivery
Time frame: During each treatment fraction
Patient reported outcome measures
To assess baseline, acute and late International Prostate Symptom Score (IPSS). IPSS ranges from 0 to 35. Lower scores are better: A lower score indicates fewer or less severe urinary symptoms, while a higher score suggests more severe symptoms.
Time frame: Baseline, at completion of radiotherapy, Week 2, Week 4, Week 12, 6 months, 1 year, and 2 years after treatment completion
Patient reported outcome measures
Expanded Prostate Cancer Index Composite Short Form (EPIC-26). EPIC-26 scores are transformed to a 0-100 scale for each domain.The questionnaire usually covers urinary incontinence, urinary irritative/obstructive symptoms, bowel, sexual, and hormonal functions. Higher scores represent better health-related quality of life.
Time frame: Baseline, 4 and 12 weeks, 6 months, 1 and 2 years post treatment.
Patient reported outcome measures
International Index of Erectile Function-5 (IIEF-5). The IIEF-5 score ranges from 5 to 25. Higher scores are better: A higher score indicates better erectile function, while a lower score suggests more severe erectile dysfunction.
Time frame: Baseline, 6 months, 1 and 2 years post treatment.
PSA kinetics
To assess biochemical relapse-free survival at 2 years
Time frame: Baseline (prior to starting ADT), Week 12, Month 6, Year 1, and Year 2 after treatment completion
Plan to share: Yes — It is intended that data will be shared within the MOMENTUM collaboration, between centres delivering treatment in the same way as DESTINATION2. Pseudonymised data will be stored within MOMENTUM for at least 5 years. Storage will be cloud based and as the treating centre we will have free access to the data and control over who else can assess it.
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Sunnybrook Health Sciences Centre