Prostate CancerPhase 3NCT00175396
Androgen Suppression Combined With Elective Nodal and Dose Escalated Radiation Therapy
A Phase 3 study testing Androgen suppression, radiotherapy and Androgen suppression, radiotherapy, iodine 125 brachytherapy in people with Prostate Cancer, run by University of British Columbia at 1 site in Canada.
Trial summary
The purpose of this trial is to compare two similar treatments for patients diagnosed with prostate cancer. The two treatment arms being compared are: (Standard Arm) hormone therapy, which will prevent the production of the male hormone, testosterone, by the testicles, and pelvic external beam radiation therapy (EBRT)… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Androgen suppression, radiotherapy and Androgen suppression, radiotherapy, iodine 125 brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- May 2004to Jun 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically-proven prostate cancer stage T1c -T3a (UICC 1997).
- Patients with clinically organ-confined disease must meet the Canadian consensus definition of intermediate risk disease (i.e any one or more of: CS = T2b [UICC1997 = bilateral palpable intra-capsular disease], GS = 7, or iPSA >10 and 20).
- Patients with Gleason sum 8 and/or PSA > 20 must have a CT pelvis, and nuclear medicine bone scan showing no evidence of nodal (N0) or distant metastases (M0).
- Registration must occur within 36 weeks of biopsy.
- Patients with clinical or pathological evidence of seminal vesicle invasion (stage T3b) or involvement of adjacent pelvic organs/structures (stage T4) are not eligible.
- Pre-intervention PSA must not exceed 40 ng ml-1.
Show all 22Show fewer
- Patients must have a chest x-ray and the following blood tests within four weeks of registration: PSA, PAP, testosterone, CBC, electrolytes, BUN, creatinine, AST, LDH and alkaline phosphatase. Patients with values for one or more of these tests that fall outside the normal range will not necessarily be ineligible, however, their eligibility will need to be reviewed by the study coordinator.
- Patients must have an ECG within four weeks of registration. Patients with ECGs judged to be significantly abnormal require a consultation with a cardiologist to ascertain their suitability for general or spinal anesthesia.
- Patients judged clinically to have a prostate volume > 65 cm3 prior to starting androgen suppression must have a transrectal ultrasound for volume estimation. Patients with TRUS prostate volumes > 75 cm3 prior to starting androgen suppression are not eligible for the study.
- Patients may have been started on neoadjuvant androgen suppression prior to registration provided:
- there is documentation of pre-treatment PSA and
- in the case of patients with iPSA >20 and/or Gleason sum 8, a bone scan and CT pelvis were done prior to or within 4 weeks after starting neoadjuvant androgen suppression.
- Patients must not have received prior surgical treatment for prostate cancer including transurethral resection of the prostate (TURP), transurethral resection of the bladder neck (TURB), cryotherapy, laser ablation, or microwave therapy.
- Patients should have an estimated life expectancy of at least 5 years with an ECOG performance status of 0-2.
- Patients may not have received prior radiation therapy to the pelvis.
- Patients must be fit for general or spinal anesthetic.
- Patients on Coumadin therapy must be able to stop the therapy safely for at least 12 days. Documentation as to the safety of such an interruption in anticoagulation therapy must be provided by an appropriate specialist physician (usually a cardiologist or hematologist).
- Patients must be judged to have no contraindication to high dose pelvic irradiation or LHRH agonist therapy.
- Cancer survivors are eligible providing that all three of the following criteria are met:
- The patient has undergone potentially curative therapy for all prior malignancies.
- There has been no evidence of recurrence for at least five years following potentially curative therapy. (For non-melanoma skin cancer the five-year requirement does not apply.)
- The patient is considered by the treating physician to be at low risk of recurrence from prior malignancies.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Phase III Study Comparing Androgen Suppression and Elective Pelvic Nodal Irradiation Followed by High Dose 3-D Conformal Boost Versus Androgen Suppression and Elective Pelvic Nodal Irradiation Followed by 125-Iodine Brachytherapy Implant Boost for Patients With Intermediate and High Risk Localized Prostate Cancer
The purpose of this trial is to compare two similar treatments for patients diagnosed with prostate cancer. The two treatment arms being compared are: (Standard Arm) hormone therapy, which will prevent the production of the male hormone, testosterone, by the testicles, and pelvic external beam radiation therapy (EBRT) followed by a high-dose, conformal EBRT boost versus (Investigational Arm) hormone therapy and pelvic EBRT followed by a brachytherapy boost (implantation of radioactive iodine sources or "seeds" into the prostate).
The hypothesis of this trial is that more patients may experience 5 year actuarial freedom from biochemical recurrence of their prostate cancer following treatment with the investigational arm. Biochemical failure is declared on the date when the post treatment prostate specific antigen (PSA) is > 2 ng/mL above the lowest level previously recorded.
Read the detailed description
Patients will be randomly assigned with equal probability to one or two treatment arms, Arm 1 or Arm 2, where the interventions associated with these Arms are as follows:
Arm 1:
Neoadjuvant, concurrent and adjuvant androgen suppression, elective pelvic nodal irradiation (EPNI), high dose conformal EBRT boost to the prostate, and appropriate secondary interventions at failure.
Arm 2:
Neoadjuvant, concurrent and adjuvant androgen suppression, elective pelvic nodal irradiation (EPNI), permanent 125-Iodine brachytherapy boost to the prostate, and appropriate secondary interventions at failure.
If a patient is assigned to Arm 1, the radiation oncologist will initiate androgen suppression and monitor clinical and biochemical response. After an 8-month duration of neoadjuvant androgen suppression, the patient will undergo a course of elective pelvic nodal irradiation (EPNI) to a volume encompassing the prostate gland, seminal vesicles and regional lymph nodes. The pelvic irradiation will be followed by a dose-escalated 3-D conformal EBRT boost to the prostate with appropriate margins. The total radiation dose to the regional lymphatics is 46 Gy and prostate dose is 78 Gy at the ICRU reference point with a minimum dose to the PTV of > 74 Gy. Androgen suppression is maintained throughout radiation therapy and following the completion of radiation therapy until the patient has received a total duration of androgen suppression of 12 months including the neoadjuvant phase.
If the patient is assigned to Arm 2, the radiation oncologist will initiate androgen suppression and monitor clinical and biochemical response. After an 8-month duration of neoadjuvant androgen suppression, the patient will undergo a course of elective pelvic nodal irradiation (EPNI) to a volume encompassing the prostate gland, seminal vesicles and regional lymph nodes. The total radiation dose to the regional lymphatics is 46 Gy. Two weeks following the completion of the pelvic irradiation, the patient will undergo a permanent 125-Iodine brachytherapy prostate implant at the facilities of the participating institution by a team of healthcare professionals lead by a Radiation Oncologist with experience in prostate brachytherapy. To be eligible to participate, the institution must have done at least 25 cases of prostate brachytherapy with stranded sources. The minimal peripheral dose (MPD) to the prostate gland from the implant will be 115 Gy. A modified peripheral loading technique will be used in an effort to maintain the periurethral dose to < 150% of the MPD. Androgen suppression is maintained throughout radiation therapy until the patient has received a total duration of androgen suppression of 12 months including the neoadjuvant phase.
All patients randomized are part of the analysis. The patient remains on study whether or not protocol treatment defined for the assigned arm is completed. The end of the primary intervention is defined as 18 months following the start of neoadjuvant androgen suppression in both arms.
Secondary Objectives:
Overall survival, metastasis-free survival, pathological local control, incidence of acute and late side effects and complications associated with the treatment interventions, effect of the planned interventions on QOL and rate of testosterone recovery.
- Conditions
- Prostate Cancer
- Being tested
- Androgen suppression, radiotherapy, Androgen suppression, radiotherapy, iodine 125 brachytherapy
- Keywords
- ASCENDE-RT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Androgen suppression, radiotherapyProcedure or surgery
Also called Androgen suppression: non-steroidal androgen (any of flutamide, nilutamide or bicalutamide (bicalutamide is almost always used)., LHRH monotherapy: buserelin acetate or leuprolide acetate.
Total of 12 months of androgen suppression. 8 months after the start of androgen suppression 4.2-5 weeks external beam radiation (46 Gy in 23 equal fractions) followed by an external beam radiation boost lasting 3.2-4 weeks (32 Gy in 16 equal fractions).
Androgen suppression, radiotherapy, iodine 125 brachytherapyProcedure or surgery
Total of 12 months of androgen suppression. 8 months after the start of androgen suppression 4.2-5 weeks external beam radiation (46 Gy in 23 equal fractions) followed by iodine 125 brachytherapy carried out 14-25 days after the last external beam treatment.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Procedure: Androgen suppression, radiotherapy |
| 2 | Experimental | Not described Receives: Procedure: Androgen suppression, radiotherapy, iodine 125 brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end point of this trial is 5 year actuarial freedom from biochemical recurrence (5 year bNED) using the Houston definition of biochemical failure.
Measured: 5 years
Secondary outcomes (1)
This trial is also intended to determine overall survival, metastasis-free survival, pathological local control, incidence of acute and late side effects and complications associated with the treatment interventions, effect of the planned interventions.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMay 2004
- Primary completionDec 2011
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William J Morris, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00175396
- Sponsor's protocol ID
- H04-60050
- Other IDs
- H04-60050
- Status last verified
- Mar 2014
- First submitted
- 11 Sep 2005
- Last updated
- 17 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Morris WJ, Pickles T, Keyes M. Using a surgical prostate-specific antigen threshold of >0.2 ng/mL to define biochemical failure for intermediate- and high-risk prostate cancer patients treated with definitive radiation therapy in the ASCENDE-RT randomized control trial. Brachytherapy. 2018 Nov-Dec;17(6):837-844. doi: 10.1016/j.brachy.2018.08.008. Epub 2018 Sep 21.
PubMed 30245169Rodda S, Morris WJ, Hamm J, Duncan G. ASCENDE-RT: An Analysis of Health-Related Quality of Life for a Randomized Trial Comparing Low-Dose-Rate Brachytherapy Boost With Dose-Escalated External Beam Boost for High- and Intermediate-Risk Prostate Cancer. Int J Radiat Oncol Biol Phys. 2017 Jul 1;98(3):581-589. doi: 10.1016/j.ijrobp.2017.02.027. Epub 2017 Feb 21.
PubMed 28581398Rodda S, Tyldesley S, Morris WJ, Keyes M, Halperin R, Pai H, McKenzie M, Duncan G, Morton G, Hamm J, Murray N. ASCENDE-RT: An Analysis of Treatment-Related Morbidity for a Randomized Trial Comparing a Low-Dose-Rate Brachytherapy Boost with a Dose-Escalated External Beam Boost for High- and Intermediate-Risk Prostate Cancer. Int J Radiat Oncol Biol Phys. 2017 Jun 1;98(2):286-295. doi: 10.1016/j.ijrobp.2017.01.008. Epub 2017 Jan 6.
PubMed 28433432
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Study Comparing Androgen Suppression and Elective Pelvic Nodal Irradiation Followed by High Dose 3-D Conformal Boost Versus Androgen Suppression and Elective Pelvic Nodal Irradiation Followed by 125-Iodine Brachytherapy Implant Boost for Patients With Intermediate and High Risk Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT00175396
- Acronym / sponsor ID
- H04-60050
- Conditions
- Prostate Cancer
- Keywords
- ASCENDE-RT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- May 2004
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jun 2014 (estimated)
- First posted
- 15 Sep 2005 (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.
The purpose of this trial is to compare two similar treatments for patients diagnosed with prostate cancer. The two treatment arms being compared are: (Standard Arm) hormone therapy, which will prevent the production of the male hormone, testosterone, by the testicles, and pelvic external beam radiation therapy (EBRT) followed by a high-dose, conformal EBRT boost versus (Investigational Arm) hormone therapy and pelvic EBRT followed by a brachytherapy boost (implantation of radioactive iodine sources or "seeds" into the prostate).
The hypothesis of this trial is that more patients may experience 5 year actuarial freedom from biochemical recurrence of their prostate cancer following treatment with the investigational arm. Biochemical failure is declared on the date when the post treatment prostate specific antigen (PSA) is > 2 ng/mL above the lowest level previously recorded.
Detailed description
Patients will be randomly assigned with equal probability to one or two treatment arms, Arm 1 or Arm 2, where the interventions associated with these Arms are as follows:
Arm 1:
Neoadjuvant, concurrent and adjuvant androgen suppression, elective pelvic nodal irradiation (EPNI), high dose conformal EBRT boost to the prostate, and appropriate secondary interventions at failure.
Arm 2:
Neoadjuvant, concurrent and adjuvant androgen suppression, elective pelvic nodal irradiation (EPNI), permanent 125-Iodine brachytherapy boost to the prostate, and appropriate secondary interventions at failure.
If a patient is assigned to Arm 1, the radiation oncologist will initiate androgen suppression and monitor clinical and biochemical response. After an 8-month duration of neoadjuvant androgen suppression, the patient will undergo a course of elective pelvic nodal irradiation (EPNI) to a volume encompassing the prostate gland, seminal vesicles and regional lymph nodes. The pelvic irradiation will be followed by a dose-escalated 3-D conformal EBRT boost to the prostate with appropriate margins. The total radiation dose to the regional lymphatics is 46 Gy and prostate dose is 78 Gy at the ICRU reference point with a minimum dose to the PTV of > 74 Gy. Androgen suppression is maintained throughout radiation therapy and following the completion of radiation therapy until the patient has received a total duration of androgen suppression of 12 months including the neoadjuvant phase.
If the patient is assigned to Arm 2, the radiation oncologist will initiate androgen suppression and monitor clinical and biochemical response. After an 8-month duration of neoadjuvant androgen suppression, the patient will undergo a course of elective pelvic nodal irradiation (EPNI) to a volume encompassing the prostate gland, seminal vesicles and regional lymph nodes. The total radiation dose to the regional lymphatics is 46 Gy. Two weeks following the completion of the pelvic irradiation, the patient will undergo a permanent 125-Iodine brachytherapy prostate implant at the facilities of the participating institution by a team of healthcare professionals lead by a Radiation Oncologist with experience in prostate brachytherapy. To be eligible to participate, the institution must have done at least 25 cases of prostate brachytherapy with stranded sources. The minimal peripheral dose (MPD) to the prostate gland from the implant will be 115 Gy. A modified peripheral loading technique will be used in an effort to maintain the periurethral dose to < 150% of the MPD. Androgen suppression is maintained throughout radiation therapy until the patient has received a total duration of androgen suppression of 12 months including the neoadjuvant phase.
All patients randomized are part of the analysis. The patient remains on study whether or not protocol treatment defined for the assigned arm is completed. The end of the primary intervention is defined as 18 months following the start of neoadjuvant androgen suppression in both arms.
Secondary Objectives:
Overall survival, metastasis-free survival, pathological local control, incidence of acute and late side effects and complications associated with the treatment interventions, effect of the planned interventions on QOL and rate of testosterone recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Androgen suppression, radiotherapy |
| 2 | Experimental | Procedure: Androgen suppression, radiotherapy, iodine 125 brachytherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Patients must have histologically-proven prostate cancer stage T1c -T3a (UICC 1997).
- Patients with clinically organ-confined disease must meet the Canadian consensus definition of intermediate risk disease (i.e any one or more of: CS = T2b [UICC1997 = bilateral palpable intra-capsular disease], GS = 7, or iPSA >10 and 20).
- Patients with Gleason sum 8 and/or PSA > 20 must have a CT pelvis, and nuclear medicine bone scan showing no evidence of nodal (N0) or distant metastases (M0).
- Registration must occur within 36 weeks of biopsy.
- Patients with clinical or pathological evidence of seminal vesicle invasion (stage T3b) or involvement of adjacent pelvic organs/structures (stage T4) are not eligible.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Androgen suppression, radiotherapyAlso: Androgen suppression: non-steroidal androgen (any of flutamide, nilutamide or bicalutamide (bicalutamide is almost always used)., LHRH monotherapy: buserelin acetate or leuprolide acetate.Total of 12 months of androgen suppression. 8 months after the start of androgen suppression 4.2-5 weeks external beam radiation (46 Gy in 23 equal fractions) followed by an external beam radiation boost lasting 3.2-4 weeks (32 Gy in 16 equal fractions). | Procedure or surgery | 1 |
| Androgen suppression, radiotherapy, iodine 125 brachytherapyTotal of 12 months of androgen suppression. 8 months after the start of androgen suppression 4.2-5 weeks external beam radiation (46 Gy in 23 equal fractions) followed by iodine 125 brachytherapy carried out 14-25 days after the last external beam treatment. | Procedure or surgery | 2 |
Primary outcome
The primary end point of this trial is 5 year actuarial freedom from biochemical recurrence (5 year bNED) using the Houston definition of biochemical failure.
Time frame: 5 years
1 secondary outcome
This trial is also intended to determine overall survival, metastasis-free survival, pathological local control, incidence of acute and late side effects and complications associated with the treatment interventions, effect of the planned interventions.
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2014.
- Derived from this study: PubMed 30245169Morris WJ, Pickles T, Keyes M. Using a surgical prostate-specific antigen threshold of >0.2 ng/mL to define biochemical failure for intermediate- and high-risk prostate cancer patients treated with definitive radiation therapy in the ASCENDE-RT randomized control trial. Brachytherapy. 2018 Nov-Dec;17(6):837-844. doi: 10.1016/j.brachy.2018.08.008. Epub 2018 Sep 21.
- Derived from this study: PubMed 28581398Rodda S, Morris WJ, Hamm J, Duncan G. ASCENDE-RT: An Analysis of Health-Related Quality of Life for a Randomized Trial Comparing Low-Dose-Rate Brachytherapy Boost With Dose-Escalated External Beam Boost for High- and Intermediate-Risk Prostate Cancer. Int J Radiat Oncol Biol Phys. 2017 Jul 1;98(3):581-589. doi: 10.1016/j.ijrobp.2017.02.027. Epub 2017 Feb 21.
- Derived from this study: PubMed 28433432Rodda S, Tyldesley S, Morris WJ, Keyes M, Halperin R, Pai H, McKenzie M, Duncan G, Morton G, Hamm J, Murray N. ASCENDE-RT: An Analysis of Treatment-Related Morbidity for a Randomized Trial Comparing a Low-Dose-Rate Brachytherapy Boost with a Dose-Escalated External Beam Boost for High- and Intermediate-Risk Prostate Cancer. Int J Radiat Oncol Biol Phys. 2017 Jun 1;98(2):286-295. doi: 10.1016/j.ijrobp.2017.01.008. Epub 2017 Jan 6.
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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.
William J Morris, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Androgen suppression, radiotherapy and Androgen suppression, radiotherapy, iodine 125 brachytherapy in people with Prostate Cancer, run by University of British Columbia at 1 site 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 22 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 17 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
The primary end point of this trial is 5 year actuarial freedom from biochemical recurrence (5 year bNED) using the Houston definition of biochemical failure. (time frame: 5 years). 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 NCT00175396, which also lists 3 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 17 Mar 2014.