Prostate CancerPhase 3NCT02303327
Comparative Study of Radiotherapy Treatments to Treat High Risk Prostate Cancer Patients
A Phase 3 study testing EBRT + HDR brachytherapy boost, Hypofractionated Dose Escalation Radiotherapy and Androgen deprivation therapy in people with Prostate Cancer, run by Sir Mortimer B. Davis - Jewish General Hospital at 12 sites in Canada.
Trial summary
In North America, the number of new cases of prostate cancer increases every year. Many efforts have been made to develop more efficient and safer curative treatments for high risk prostate cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- EBRT + HDR brachytherapy boost, Hypofractionated Dose Escalation Radiotherapy and Androgen deprivation therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 307 participants
- Where
- 12 sitesCanada
- Study dates
- Jan 2015to Jan 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma of the prostate diagnosed within 6 months prior to randomization, (if longer than 6 months, needs to be approved by the PI).
- Clinical stage including at least one of the following: T3 or T4, Gleason Score > 8, and/ or Prostate-specific antigen (PSA) > 20 (ng/ml or μg/L).
- Pelvic and para-aortic lymph nodes must be negative on CT scan or MRI of the abdomen and pelvis performed within 12 (recommended time limit, may exceed in certain cases) weeks prior to randomization. For patients who have started androgen suppression prior to randomization, CT or MRI may be done after start of therapy, provided it is done no more than 28 days following start of androgen suppression therapy (any lymph node appearing > 1.5 cm on CT or MRI must be histologically negative by either needle aspirate or lymph node dissection performed within 12 weeks prior to randomization).
- Investigations, including chest x-ray (CXR is recommended and not mandatory) CT scan and bone scan (with radiographs of suspicious areas) have been performed within 12 weeks (recommended time limit) prior to randomization and are negative for metastases. For patients who have started androgen suppression prior to randomization, bone scan may be done up to and including 28 days after the commencement of therapy.
- Patients will have had a PSA test done at the time of diagnosis. This PSA test could be repeated within 28 days prior to randomization. The PSA value used to confirm high risk disease and the value to be entered on the eligibility checklist must be the higher of these two values. These criteria will be the same regardless of whether or not the patient has initiated hormone therapy prior to randomization.
- The patient may have received prior androgen suppression therapy provided that androgen suppression therapy commenced no more than 28 days prior to randomization.
Show all 9Show fewer
- The patient must not have received any cytotoxic anticancer therapy for prostate cancer prior to randomization. Patients may have received treatment with a 5-alpha-reductase inhibitor (e.g. Finasteride) for benign prostatic hypertrophy (BPH), which must have been discontinued prior to the randomization.
- ECOG performance status must be 0 or 1.
- Hematology and Biochemistry: Laboratory requirements have been done within 28-42 days prior to randomization: hemoglobin > 100 g/L, absolute Neutrophils > 1.5 x 109/L, platelets > 100 x 109/L, serum creatinine < 1.5 x ULN
Who cannot join
- Patients with a history of other malignancies, except: non-melanoma skin cancer; or other solid tumours curatively treated with no evidence of disease for > 5 years.
- The presence of small-cell or transitional-cell carcinoma in the biopsy specimen.
- Patients who had previous chemotherapy for carcinoma of the prostate.
- Patients who had prior surgical treatment for carcinoma of the prostate apart from trans-urethral resection, including bilateral orchiectomy.
- Patients with any contraindication to pelvic radiotherapy: including, but not limited to, previous pelvic radiotherapy. Inflammatory bowel disease (at the discretion of the treating oncologist) or severe bladder irritability.
- Patients with serious non malignant disease resulting in a life expectancy less than 3 years.
Show all 11Show fewer
- Other serious illness, psychiatric or medical condition that would not permit the patient to be managed according to the protocol including active uncontrolled infection and significant cardiac dysfunction. Patients with medical conditions that would contraindicate the treatment regimen outlined in the protocol [e.g. intake of study drugs].
- Known hypersensitivity to any protocol-indicated study medications.
- Presence of bilateral hip replacement prostheses.
- Patients with history of severe congestive heart failure will not be eligible.
- Patients with congenital long QT syndrome or patients taking Class IA, Class III or Class IC anti-arrhythmic medications will require a cardiologist's evaluation prior to eligibility assessment. Patients with cardiovascular diseases can be included as long as the benefits of androgen deprivation therapy outweigh the potential risk of cardiovascular events.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Canada12 sites
Centre Hospitalier des Vallées de l'Outaouais, Hôpital de Gatineau
Gatineau, Quebec, J8P 7H2
Lawson Health Research Institute
London, Ontario, N6C 2R5
CHUM Notre-Dame
Montreal, Quebec, H2L 4M1
Montréal General Hospital
Montreal, Quebec, H3G 1A4
Jewish General Hospital, McGill University
Montreal, Quebec, H3T 1E2
CHUQ, L'Hôtel-Dieu de Québec
Québec, Quebec, G1R 2J6
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Centre de santé Rimouski-Neigette
Rimouski, Quebec, G5L 5T1
CHUS - Hôpital Fleurimont
Sherbrooke, Quebec, J1H 5N4
Eastern Health
St. John's, Newfoundland and Labrador, A1B 3V6
Centre Hospitalier régional de Trois-Rivières
Trois-Rivières, Quebec, G8Z 3R9
Windsor Regional Hospital
Windsor, Ontario, N8W2X3
About this study
Official title: Phase III Study of Hypofractionated, Dose Escalation Radiotherapy vs. Conventional Pelvic Radiation Therapy Followed by HDR Brachy Boost for High Risk Adenocarcinoma of the Prostate (PCS-VI)
In North America, the number of new cases of prostate cancer increases every year. Many efforts have been made to develop more efficient and safer curative treatments for high risk prostate cancer patients.
This phase III clinical trial is designed to compare the safety of a standard pelvic external beam radiation therapy (EBRT) combined with a high dose rate brachytherapy (HDRB) boost (direct insertion of radiation source over a period of minutes via flexible needles temporarily inserted in the prostate) to a shorter course of hypofractionated dose escalation radiotherapy (larger radiation dose per daily treatment) in patients with high risk prostate cancer.
The investigators plan to recruit 296 patients across Quebec who will be randomized in either treatment plan.
Read the detailed description
In North America, the number of new cases of prostate cancer increases every year. To this day, the standard curative treatment for high risk prostate cancer patients is external beam radiation therapy (EBRT) combined with hormonal manipulation (Luteinizing hormone-releasing hormone LHRH agonists such as Eligard) to lower levels of testosterone to slow down or even stop the growth of prostate cancer. It has been recently demonstrated that combination of high dose rate brachytherapy (HDRB) boost (direct insertion of radiation source in the prostate for killing the tumor) to EBRT could be an effective treatment for prostate cancer patients. On the other hand, other recent studies have suggested that dose escalation and hypofractionated radiation delivery (larger radiation dose per daily treatment) can be more efficient than standard fractionation in prostate cancer patients.
This phase III clinical trial is designed to compare the safety of a conventional pelvic EBRT combined with a HDRB boost (i.e. 46 Gy in 23 fractions followed by a 15-Gy HDRB boost) to a shorter course of hypofractionated dose escalation radiotherapy (i.e. 68 Gy in 25 fractions) in patients with high risk prostate cancer. The patients will be randomized to either of the two different courses of treatment. All the patients will be also treated with hormonal therapy for a total duration of 28 months (2 months before radiation therapy (RT), 2 months during RT and for 24 months after RT). The patients will undergo different test before the treatment, such as bone scan, blood test, CT scan and bone density. The patient's follow-up will be the first month after start of RT, every 4 months for the first 2 years, then every 6 months the third year and then annually for 10 years. On every visit, the patient will undergo digital rectal examination (DRE) as well as evaluation of testosterone and prostate specific antigen (PSA) levels.
The safety of the new course of radiation therapy will be evaluated by the acute (at and before 90 days) and delayed toxicities (at 90 days, at 180 days and after) measured by Common Terminology Criteria for Adverse Events (CTCAE version 4). We will also determine Biochemical Failure Free Survival, Distant Metastasis Free Survival, Disease Specific Survival, Overall Survival and the Health-related Quality of Life using the Expanded Prostate Cancer Index Composite (EPIC). We will also monitor the development of gastrointestinal and genitourinary toxicities and establish the predictive value of PTEN deletion and TMPRSS2ETS fusion (genetic markers to predict the nature and progression of prostate tumors).
This study will be conducted through the Genitourinary Radiation Oncology Group of Quebec (GROUQ) in 12 selected radiation oncology centers. We plan to recruit 296 patients across Quebec and the recruitment should be completed within 24 months of activation.
- Conditions
- Prostate Cancer
- Being tested
- EBRT + HDR brachytherapy boost, Hypofractionated Dose Escalation Radiotherapy, Androgen deprivation therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBRT + HDR brachytherapy boostRadiation
Standard radiotherapy (EBRT, 23 fractions) with the addition of High Dose-Rate (HDR) brachytherapy boost within 3 weeks of beginning or finishing the EBRT.
Hypofractionated Dose Escalation RadiotherapyRadiation
Radiation therapy (higher radiation dose per treatment) will be given once a day, five days a week, over approximately 5 weeks.
Androgen deprivation therapyDrug
Also called ADT
28 months of androgen deprivation therapy (injections every 4 months for a total of 28 months)
| Study group | Role | What they receive |
|---|---|---|
| ADT+EBRT+ HDR brachytherapy boost | Other | Standard fractionation radiotherapy: 46 Gy in 23 fractions (EBRT) and a 15-Gy HDRB boost in conjunction with 28 months of androgen deprivation therapy (ADT). Receives: Radiation: EBRT + HDR brachytherapy boost; Drug: Androgen deprivation therapy |
| ADT+Hypofractionated Dose Escalation RT | Active comparator | Hypofractionated dose escalation radiotherapy: 68 Gy in 25 fractions in conjunction with 28 months of androgen deprivation therapy (ADT). Receives: Radiation: Hypofractionated Dose Escalation Radiotherapy; Drug: Androgen deprivation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute and delayed toxicity differences measured by Common Terminology Criteria for Adverse Events (CTCAE) version 4.
Measured: The acute toxicity will be evaluated at or before 90 days and for the delayed toxicity, it will be determined at 90 -180 days and after (persisting or appearing after 180 days).
Secondary outcomes (9)
Freedom from biochemical failure measured by PSA level.
an increase by 2 ng/mL or more above the nadir PSA is considered as biochemical failure
Measured: At 3 and 5 years.
Rate of local failures measured by number of recurrences in the prostate.
Measured: At 3 and 5 years.
Rate of regional failures measured by number of recurrences in the lymph nodes.
Measured: At 3 and 5 years.
Rate of distant failures measured by number of metastases.
Measured: At 3 and 5 years.
Disease specific survival measured by number of deaths associated to the prostate cancer.
Measured: At 5 years.
Disease overall survival measured by the number of deaths after 5 years.
Measured: At 5 years.
Health-related quality of life measured by using Expanded Prostate Cancer Index Composite (EPIC) questionnaire
Measured: At every routine visit (baseline, 3 to 4 weeks after RT, every 4 months for 2 years, every 6 months the 3 following years and then annually until 10 years).
Correlation of dose-volume histogram of the rectum and bladder by studying wall and whole organ volumes to the development of gastrointestinal (GI) and genitourinary (GU) toxicity.
Measured: At 180 days post treatment
Predictive value of the PTEN deletion and TMPRSS2-ETS gene fusion in high risk prostate cancer patients.
looking for correlation between these known gene mutations and local and/or distal recurrences.
Measured: At the time when biopsy is done, < 6 months before randomization of participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Tamim Niazi, Sir Mortimer B. Davis - Jewish General Hospital
- Investigators
- Tamim Niazi, MD, Principal investigator, Jewish General Hospital, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02303327
- Sponsor's protocol ID
- PCS VI
- Status last verified
- Dec 2024
- First submitted
- 10 Nov 2014
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Canadian Cancer Statistics 2010. www.cancer.ca.
Levy IG, Gibbons L, Collins JP, Perkins DG, Mao Y. Prostate cancer trends in Canada: rising incidence or increased detection? CMAJ. 1993 Sep 1;149(5):617-24.
PubMed 8364818Pilepich MV, Winter K, John MJ, Mesic JB, Sause W, Rubin P, Lawton C, Machtay M, Grignon D. Phase III radiation therapy oncology group (RTOG) trial 86-10 of androgen deprivation adjuvant to definitive radiotherapy in locally advanced carcinoma of the prostate. Int J Radiat Oncol Biol Phys. 2001 Aug 1;50(5):1243-52. doi: 10.1016/s0360-3016(01)01579-6.
PubMed 11483335McCammon R, Rusthoven KE, Kavanagh B, Newell S, Newman F, Raben D. Toxicity assessment of pelvic intensity-modulated radiotherapy with hypofractionated simultaneous integrated boost to prostate for intermediate- and high-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2009 Oct 1;75(2):413-20. doi: 10.1016/j.ijrobp.2008.10.050. Epub 2009 Apr 11.
PubMed 19362783Pervez N, Small C, MacKenzie M, Yee D, Parliament M, Ghosh S, Mihai A, Amanie J, Murtha A, Field C, Murray D, Fallone G, Pearcey R. Acute toxicity in high-risk prostate cancer patients treated with androgen suppression and hypofractionated intensity-modulated radiotherapy. Int J Radiat Oncol Biol Phys. 2010 Jan 1;76(1):57-64. doi: 10.1016/j.ijrobp.2009.01.048.
PubMed 19395192Hong TS, Tome WA, Jaradat H, Raisbeck BM, Ritter MA. Pelvic nodal dose escalation with prostate hypofractionation using conformal avoidance defined (H-CAD) intensity modulated radiation therapy. Acta Oncol. 2006;45(6):717-27. doi: 10.1080/02841860600781781.
PubMed 16938815Arcangeli G, Saracino B, Gomellini S, Petrongari MG, Arcangeli S, Sentinelli S, Marzi S, Landoni V, Fowler J, Strigari L. A prospective phase III randomized trial of hypofractionation versus conventional fractionation in patients with high-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2010 Sep 1;78(1):11-8. doi: 10.1016/j.ijrobp.2009.07.1691. Epub 2010 Jan 4.
PubMed 20047800Hsu IC, Pickett B, Shinohara K, Krieg R, Roach M 3rd, Phillips T. Normal tissue dosimetric comparison between HDR prostate implant boost and conformal external beam radiotherapy boost: potential for dose escalation. Int J Radiat Oncol Biol Phys. 2000 Mar 1;46(4):851-8. doi: 10.1016/s0360-3016(99)00501-5.
PubMed 10705005Sathya JR, Davis IR, Julian JA, Guo Q, Daya D, Dayes IS, Lukka HR, Levine M. Randomized trial comparing iridium implant plus external-beam radiation therapy with external-beam radiation therapy alone in node-negative locally advanced cancer of the prostate. J Clin Oncol. 2005 Feb 20;23(6):1192-9. doi: 10.1200/JCO.2005.06.154.
PubMed 15718316Guix B, et al. Treatment of Intermediate-or High-risk Prostate Cancer by Dose Escalation with High-dose 3D-conformal Radiotherapy (HD-3D-CRT) or Low-dose 3D-conformal Radiotherapy Plus HDR Brachytherapy (LD-3D-CRT+HDR-B): Early Results of a Prospective Comparative Trial. Int J Radiat Oncol Biol Phys. 78[3], S78. 11-1-2010.
Cury FL, Duclos M, Aprikian A, Patrocinio H, Kassouf W, Shenouda G, Faria S, David M, Souhami L. Single-fraction high-dose-rate brachytherapy and hypofractionated external beam radiation therapy in the treatment of intermediate-risk prostate cancer - long term results. Int J Radiat Oncol Biol Phys. 2012 Mar 15;82(4):1417-23. doi: 10.1016/j.ijrobp.2011.05.025. Epub 2011 Jul 23.
PubMed 21784585Roach M 3rd, Bae K, Speight J, Wolkov HB, Rubin P, Lee RJ, Lawton C, Valicenti R, Grignon D, Pilepich MV. Short-term neoadjuvant androgen deprivation therapy and external-beam radiotherapy for locally advanced prostate cancer: long-term results of RTOG 8610. J Clin Oncol. 2008 Feb 1;26(4):585-91. doi: 10.1200/JCO.2007.13.9881. Epub 2008 Jan 2.
PubMed 18172188Roach M 3RD, Lu J, Pilepich MV, Asbell SO, Mohiuddin M, Terry R, Grignon D, Lawton C, Shipley W, Cox J. Predicting long-term survival, and the need for hormonal therapy: a meta-analysis of RTOG prostate cancer trials. Int J Radiat Oncol Biol Phys. 2000 Jun 1;47(3):617-27. doi: 10.1016/s0360-3016(00)00577-0.
PubMed 10837944
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Hypofractionated, Dose Escalation Radiotherapy vs. Conventional Pelvic Radiation Therapy Followed by HDR Brachy Boost for High Risk Adenocarcinoma of the Prostate (PCS-VI)
- ClinicalTrials.gov ID
- NCT02303327
- Acronym / sponsor ID
- PCS VI
- Conditions
- Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 307 participants (actual)
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 27 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In North America, the number of new cases of prostate cancer increases every year. Many efforts have been made to develop more efficient and safer curative treatments for high risk prostate cancer patients.
This phase III clinical trial is designed to compare the safety of a standard pelvic external beam radiation therapy (EBRT) combined with a high dose rate brachytherapy (HDRB) boost (direct insertion of radiation source over a period of minutes via flexible needles temporarily inserted in the prostate) to a shorter course of hypofractionated dose escalation radiotherapy (larger radiation dose per daily treatment) in patients with high risk prostate cancer.
The investigators plan to recruit 296 patients across Quebec who will be randomized in either treatment plan.
Detailed description
In North America, the number of new cases of prostate cancer increases every year. To this day, the standard curative treatment for high risk prostate cancer patients is external beam radiation therapy (EBRT) combined with hormonal manipulation (Luteinizing hormone-releasing hormone LHRH agonists such as Eligard) to lower levels of testosterone to slow down or even stop the growth of prostate cancer. It has been recently demonstrated that combination of high dose rate brachytherapy (HDRB) boost (direct insertion of radiation source in the prostate for killing the tumor) to EBRT could be an effective treatment for prostate cancer patients. On the other hand, other recent studies have suggested that dose escalation and hypofractionated radiation delivery (larger radiation dose per daily treatment) can be more efficient than standard fractionation in prostate cancer patients.
This phase III clinical trial is designed to compare the safety of a conventional pelvic EBRT combined with a HDRB boost (i.e. 46 Gy in 23 fractions followed by a 15-Gy HDRB boost) to a shorter course of hypofractionated dose escalation radiotherapy (i.e. 68 Gy in 25 fractions) in patients with high risk prostate cancer. The patients will be randomized to either of the two different courses of treatment. All the patients will be also treated with hormonal therapy for a total duration of 28 months (2 months before radiation therapy (RT), 2 months during RT and for 24 months after RT). The patients will undergo different test before the treatment, such as bone scan, blood test, CT scan and bone density. The patient's follow-up will be the first month after start of RT, every 4 months for the first 2 years, then every 6 months the third year and then annually for 10 years. On every visit, the patient will undergo digital rectal examination (DRE) as well as evaluation of testosterone and prostate specific antigen (PSA) levels.
The safety of the new course of radiation therapy will be evaluated by the acute (at and before 90 days) and delayed toxicities (at 90 days, at 180 days and after) measured by Common Terminology Criteria for Adverse Events (CTCAE version 4). We will also determine Biochemical Failure Free Survival, Distant Metastasis Free Survival, Disease Specific Survival, Overall Survival and the Health-related Quality of Life using the Expanded Prostate Cancer Index Composite (EPIC). We will also monitor the development of gastrointestinal and genitourinary toxicities and establish the predictive value of PTEN deletion and TMPRSS2ETS fusion (genetic markers to predict the nature and progression of prostate tumors).
This study will be conducted through the Genitourinary Radiation Oncology Group of Quebec (GROUQ) in 12 selected radiation oncology centers. We plan to recruit 296 patients across Quebec and the recruitment should be completed within 24 months of activation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADT+EBRT+ HDR brachytherapy boost | Other | Radiation: EBRT + HDR brachytherapy boost, Drug: Androgen deprivation therapyStandard fractionation radiotherapy: 46 Gy in 23 fractions (EBRT) and a 15-Gy HDRB boost in conjunction with 28 months of androgen deprivation therapy (ADT). |
| ADT+Hypofractionated Dose Escalation RT | Active comparator | Radiation: Hypofractionated Dose Escalation Radiotherapy, Drug: Androgen deprivation therapyHypofractionated dose escalation radiotherapy: 68 Gy in 25 fractions in conjunction with 28 months of androgen deprivation therapy (ADT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed adenocarcinoma of the prostate diagnosed within 6 months prior to randomization, (if longer than 6 months, needs to be approved by the PI).
- Clinical stage including at least one of the following: T3 or T4, Gleason Score > 8, and/ or Prostate-specific antigen (PSA) > 20 (ng/ml or μg/L).
- Pelvic and para-aortic lymph nodes must be negative on CT scan or MRI of the abdomen and pelvis performed within 12 (recommended time limit, may exceed in certain cases) weeks prior to randomization. For patients who have started androgen suppression prior to randomization, CT or MRI may be done after start of therapy, provided it is done no more than 28 days following start of androgen suppression therapy (any lymph node appearing > 1.5 cm on CT or MRI must be histologically negative by either needle aspirate or lymph node dissection performed within 12 weeks prior to randomization).
- Investigations, including chest x-ray (CXR is recommended and not mandatory) CT scan and bone scan (with radiographs of suspicious areas) have been performed within 12 weeks (recommended time limit) prior to randomization and are negative for metastases. For patients who have started androgen suppression prior to randomization, bone scan may be done up to and including 28 days after the commencement of therapy.
- Patients will have had a PSA test done at the time of diagnosis. This PSA test could be repeated within 28 days prior to randomization. The PSA value used to confirm high risk disease and the value to be entered on the eligibility checklist must be the higher of these two values. These criteria will be the same regardless of whether or not the patient has initiated hormone therapy prior to randomization.
Key exclusion criteria (11 listed)
- Patients with a history of other malignancies, except: non-melanoma skin cancer; or other solid tumours curatively treated with no evidence of disease for > 5 years.
- The presence of small-cell or transitional-cell carcinoma in the biopsy specimen.
- Patients who had previous chemotherapy for carcinoma of the prostate.
- Patients who had prior surgical treatment for carcinoma of the prostate apart from trans-urethral resection, including bilateral orchiectomy.
- Patients with any contraindication to pelvic radiotherapy: including, but not limited to, previous pelvic radiotherapy. Inflammatory bowel disease (at the discretion of the treating oncologist) or severe bladder irritability.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EBRT + HDR brachytherapy boostStandard radiotherapy (EBRT, 23 fractions) with the addition of High Dose-Rate (HDR) brachytherapy boost within 3 weeks of beginning or finishing the EBRT. | Radiation | ADT+EBRT+ HDR brachytherapy boost |
| Hypofractionated Dose Escalation RadiotherapyRadiation therapy (higher radiation dose per treatment) will be given once a day, five days a week, over approximately 5 weeks. | Radiation | ADT+Hypofractionated Dose Escalation RT |
| Androgen deprivation therapyAlso: ADT28 months of androgen deprivation therapy (injections every 4 months for a total of 28 months) | Drug | ADT+EBRT+ HDR brachytherapy boost, ADT+Hypofractionated Dose Escalation RT |
Primary outcome
Acute and delayed toxicity differences measured by Common Terminology Criteria for Adverse Events (CTCAE) version 4.
Time frame: The acute toxicity will be evaluated at or before 90 days and for the delayed toxicity, it will be determined at 90 -180 days and after (persisting or appearing after 180 days).
9 secondary outcomes
Freedom from biochemical failure measured by PSA level.
Time frame: At 3 and 5 years.
Rate of local failures measured by number of recurrences in the prostate.
Time frame: At 3 and 5 years.
Rate of regional failures measured by number of recurrences in the lymph nodes.
Time frame: At 3 and 5 years.
Rate of distant failures measured by number of metastases.
Time frame: At 3 and 5 years.
Disease specific survival measured by number of deaths associated to the prostate cancer.
Time frame: At 5 years.
Disease overall survival measured by the number of deaths after 5 years.
Time frame: At 5 years.
Health-related quality of life measured by using Expanded Prostate Cancer Index Composite (EPIC) questionnaire
Time frame: At every routine visit (baseline, 3 to 4 weeks after RT, every 4 months for 2 years, every 6 months the 3 following years and then annually until 10 years).
Correlation of dose-volume histogram of the rectum and bladder by studying wall and whole organ volumes to the development of gastrointestinal (GI) and genitourinary (GU) toxicity.
Time frame: At 180 days post treatment
Predictive value of the PTEN deletion and TMPRSS2-ETS gene fusion in high risk prostate cancer patients.
Time frame: At the time when biopsy is done, < 6 months before randomization of participant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- BackgroundCanadian Cancer Statistics 2010. www.cancer.ca.
- Background: PubMed 8364818Levy IG, Gibbons L, Collins JP, Perkins DG, Mao Y. Prostate cancer trends in Canada: rising incidence or increased detection? CMAJ. 1993 Sep 1;149(5):617-24.
- Background: PubMed 11483335Pilepich MV, Winter K, John MJ, Mesic JB, Sause W, Rubin P, Lawton C, Machtay M, Grignon D. Phase III radiation therapy oncology group (RTOG) trial 86-10 of androgen deprivation adjuvant to definitive radiotherapy in locally advanced carcinoma of the prostate. Int J Radiat Oncol Biol Phys. 2001 Aug 1;50(5):1243-52. doi: 10.1016/s0360-3016(01)01579-6.
- Background: PubMed 19362783McCammon R, Rusthoven KE, Kavanagh B, Newell S, Newman F, Raben D. Toxicity assessment of pelvic intensity-modulated radiotherapy with hypofractionated simultaneous integrated boost to prostate for intermediate- and high-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2009 Oct 1;75(2):413-20. doi: 10.1016/j.ijrobp.2008.10.050. Epub 2009 Apr 11.
- Background: PubMed 19395192Pervez N, Small C, MacKenzie M, Yee D, Parliament M, Ghosh S, Mihai A, Amanie J, Murtha A, Field C, Murray D, Fallone G, Pearcey R. Acute toxicity in high-risk prostate cancer patients treated with androgen suppression and hypofractionated intensity-modulated radiotherapy. Int J Radiat Oncol Biol Phys. 2010 Jan 1;76(1):57-64. doi: 10.1016/j.ijrobp.2009.01.048.
- Background: PubMed 16938815Hong TS, Tome WA, Jaradat H, Raisbeck BM, Ritter MA. Pelvic nodal dose escalation with prostate hypofractionation using conformal avoidance defined (H-CAD) intensity modulated radiation therapy. Acta Oncol. 2006;45(6):717-27. doi: 10.1080/02841860600781781.
- Background: PubMed 20047800Arcangeli G, Saracino B, Gomellini S, Petrongari MG, Arcangeli S, Sentinelli S, Marzi S, Landoni V, Fowler J, Strigari L. A prospective phase III randomized trial of hypofractionation versus conventional fractionation in patients with high-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2010 Sep 1;78(1):11-8. doi: 10.1016/j.ijrobp.2009.07.1691. Epub 2010 Jan 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamim Niazi, MD principal investigator
Jewish General Hospital, McGill University
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EBRT + HDR brachytherapy boost, Hypofractionated Dose Escalation Radiotherapy and Androgen deprivation therapy in people with Prostate Cancer, run by Sir Mortimer B. Davis - Jewish General Hospital at 12 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute and delayed toxicity differences measured by Common Terminology Criteria for Adverse Events (CTCAE) version 4. (time frame: The acute toxicity will be evaluated at or before 90 days and for the delayed toxicity, it will be determined at 90 -180 days and after (persisting or appearing after 180 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02303327, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.