Adenocarcinoma of the ProstatePhase 2NCT01255891
Adjuvant Androgen Suppression Plus Radiation Therapy for High-Risk Localized Adenocarcinoma Prostate
A Phase 2 study testing Androgen suppression plus radiation therapy in people with Adenocarcinoma of the Prostate, run by Dr. Tamim Niazi at 2 sites in Canada.
Trial summary
To evaluate the efficacy of LHRH agonist with adjuvant pelvic radiation therapy in post radical prostatectomy patients with high risk pathological features for failure. To determine the freedom from biochemical (maintenance of a PSA less than nadir + 2 ng/ml) and clinical progression rate at 5 years. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Adenocarcinoma of the Prostate
- What is being tested?
- Androgen suppression plus radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2010to 1 Sep 2023
- Phase
- Phase 2
- 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 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adenocarcinoma of the prostate treated primarily with radical prostatectomy, pathologically proven to be lymph node negative by pelvic lymphadenectomy (N0) or lymph node status pathologically unknown (undissected pelvic lymph nodes [Nx]), i.e. lymph node dissection is not required;
- Any type of radical prostatectomy will be permitted, including retropubic, perineal laparoscopic or robotically assisted. If performed, the number of lymph nodes removed per side of the pelvis and the extent of the pelvic lymph node dissection (obturator vs. extended lymph node dissection) should be noted. There is no time limit for the date of radical prostatectomy.
- A post-radical prostatectomy entry PSA of > 0 and < 1 ng/ml at least 6 weeks after prostatectomy and within 30 days of registration.
- One of the following pathologic/chemical classifications:
- T3N0/Nx disease with or without positive surgical margin; or;
- Gleason score of 8 or more;
Show all 18Show fewer
- Pre prostatectomy PSA > 20 ng/ml
- KPS > 70
- Age ≥ 18;
- No distant metastases, based upon the following minimum diagnostic workup:
- History/physical examination (including digital rectal exam) within 8 wks prior to registration;
- A CT scan or MRI of the abdomen and pelvis within 120 days prior to registration;
- Bone scan within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis.
- Adequate bone marrow function, within 90 days prior to registration, defined as follows:
- Platelets ≥ 100,000 cells/mm3 based upon CBC;
- Hemoglobin ≥ 10.0 g/dl based upon CBC
- AST or ALT < 2 x the upper limit of normal within 90 days prior to registration;
- Patients must sign a study-specific informed consent prior to study entry.
Who cannot join
- A palpable prostatic fossa abnormality/mass suggestive of recurrence, unless shown by biopsy under ultrasound guidance not to contain cancer;
- N1 patients are ineligible, as are those with pelvic lymph node enlargement ≥ 1.5 cm in greatest dimension by CT scan or MRI of the pelvis, unless the enlarged lymph node is sampled and is negative;
- Androgen deprivation therapy started prior to prostatectomy for > 6 months duration;
- Androgen deprivation therapy started after prostatectomy and prior to registration;
- Prior pelvic radiotherapy;
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 5 years (for example, carcinoma in situ of the oral cavity is permissible);
Show all 15Show fewer
- Severe, active co-morbidity, defined as follows:
- History of inflammatory bowel disease;
- History of hepatitis B or C; Blood tests are not required to determine if the patient has had hepatitis B or C, unless the patient reports a history of hepatitis.
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration;
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; AST or ALT are required; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol.
- Prior allergic reaction to the study drug(s) involved in this protocol.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Montreal General Hospital
Montreal, Quebec, H3G 1Y6
Jewish General Hospital
Montreal, Quebec, H3T 1E2
About this study
Official title: A Phase II Study of Adjuvant Androgen Suppression Plus Radiation Therapy for High-Risk Localized Adenocarcinoma of the Prostate
To evaluate the efficacy of LHRH agonist with adjuvant pelvic radiation therapy in post radical prostatectomy patients with high risk pathological features for failure. To determine the freedom from biochemical (maintenance of a PSA less than nadir + 2 ng/ml) and clinical progression rate at 5 years.
Read the detailed description
Same as brief Summary
- Conditions
- Adenocarcinoma of the Prostate
- Being tested
- Androgen suppression plus radiation therapy
- Keywords
- high risk localized adenocarcinoma of the prostate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Androgen suppression plus radiation therapyRadiation
Adjuvant androgen suppression plus radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant | Other | Adjuvant suppression plus radiation therapy Receives: Radiation: Androgen suppression plus radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine the rate of local and distance failure at 5 years
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 posted8 Dec 2010 (estimated)
- Study startJan 2010
- Primary completion1 Aug 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adenocarcinoma of the ProstateStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Tamim Niazi
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie (prior sponsor, Abbott)
- Responsible party
- Sponsor-investigator, Dr. Tamim Niazi, Sir Mortimer B. Davis - Jewish General Hospital
- Investigators
- Tamim Niazi, MD, Principal investigator, McGill University Department of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255891
- Sponsor's protocol ID
- McG 0913
- Status last verified
- Dec 2024
- First submitted
- 7 Dec 2010
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Elakshar S, Tolba M, Tisseverasinghe S, Pruneau L, Di Lalla V, Bahoric B, Niazi T. Salvage Whole-Pelvic Radiation and Long-Term Androgen-Deprivation Therapy in the Management of High-Risk Prostate Cancer: Long-Term Update of the McGill 0913 Study. Curr Oncol. 2023 Aug 1;30(8):7252-7262. doi: 10.3390/curroncol30080526.
PubMed 37623007Kucharczyk MJ, Tsui JMG, Khosrow-Khavar F, Bahoric B, Souhami L, Anidjar M, Probst S, Chaddad A, Sargos P, Niazi T. Combined Long-Term Androgen Deprivation and Pelvic Radiotherapy in the Post-operative Management of Pathologically Defined High-Risk Prostate Cancer Patients: Results of the Prospective Phase II McGill 0913 Study. Front Oncol. 2020 Mar 12;10:312. doi: 10.3389/fonc.2020.00312. eCollection 2020.
PubMed 32226774
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Adjuvant Androgen Suppression Plus Radiation Therapy for High-Risk Localized Adenocarcinoma of the Prostate
- ClinicalTrials.gov ID
- NCT01255891
- Acronym / sponsor ID
- McG 0913
- Conditions
- Adenocarcinoma of the Prostate
- Keywords
- high risk localized adenocarcinoma of the prostate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Dr. Tamim NiaziUniversity, hospital or other
- Collaborators
- AbbVie (prior sponsor, Abbott)
- Study start
- Jan 2010
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 8 Dec 2010 (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.
To evaluate the efficacy of LHRH agonist with adjuvant pelvic radiation therapy in post radical prostatectomy patients with high risk pathological features for failure. To determine the freedom from biochemical (maintenance of a PSA less than nadir + 2 ng/ml) and clinical progression rate at 5 years.
Detailed description
Same as brief Summary
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adjuvant | Other | Radiation: Androgen suppression plus radiation therapyAdjuvant suppression plus radiation therapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Adenocarcinoma of the prostate treated primarily with radical prostatectomy, pathologically proven to be lymph node negative by pelvic lymphadenectomy (N0) or lymph node status pathologically unknown (undissected pelvic lymph nodes [Nx]), i.e. lymph node dissection is not required;
- Any type of radical prostatectomy will be permitted, including retropubic, perineal laparoscopic or robotically assisted. If performed, the number of lymph nodes removed per side of the pelvis and the extent of the pelvic lymph node dissection (obturator vs. extended lymph node dissection) should be noted. There is no time limit for the date of radical prostatectomy.
- A post-radical prostatectomy entry PSA of > 0 and < 1 ng/ml at least 6 weeks after prostatectomy and within 30 days of registration.
- One of the following pathologic/chemical classifications:
- KPS > 70
Key exclusion criteria (15 listed)
- A palpable prostatic fossa abnormality/mass suggestive of recurrence, unless shown by biopsy under ultrasound guidance not to contain cancer;
- N1 patients are ineligible, as are those with pelvic lymph node enlargement ≥ 1.5 cm in greatest dimension by CT scan or MRI of the pelvis, unless the enlarged lymph node is sampled and is negative;
- Androgen deprivation therapy started prior to prostatectomy for > 6 months duration;
- Androgen deprivation therapy started after prostatectomy and prior to registration;
- Prior pelvic radiotherapy;
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 plus radiation therapyAdjuvant androgen suppression plus radiation therapy | Radiation | Adjuvant |
Primary outcome
to determine the rate of local and distance failure at 5 years
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Derived from this study: PubMed 37623007Elakshar S, Tolba M, Tisseverasinghe S, Pruneau L, Di Lalla V, Bahoric B, Niazi T. Salvage Whole-Pelvic Radiation and Long-Term Androgen-Deprivation Therapy in the Management of High-Risk Prostate Cancer: Long-Term Update of the McGill 0913 Study. Curr Oncol. 2023 Aug 1;30(8):7252-7262. doi: 10.3390/curroncol30080526.
- Derived from this study: PubMed 32226774Kucharczyk MJ, Tsui JMG, Khosrow-Khavar F, Bahoric B, Souhami L, Anidjar M, Probst S, Chaddad A, Sargos P, Niazi T. Combined Long-Term Androgen Deprivation and Pelvic Radiotherapy in the Post-operative Management of Pathologically Defined High-Risk Prostate Cancer Patients: Results of the Prospective Phase II McGill 0913 Study. Front Oncol. 2020 Mar 12;10:312. doi: 10.3389/fonc.2020.00312. eCollection 2020.
- Research pageLink provided by the sponsor.
Related trials for Adenocarcinoma of the Prostate
Active, not recruitingEarly Phase 1
Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression
Prostate Adenocarcinoma, Prostate Cancer
RecruitingPhase 2
Estrogen to Improve Quality of Life for Men With Newly Diagnosed or Recurrent Metastatic Hormone Sensitive Prostate Cancer, EQUIP Trial
Castration-Sensitive Prostate Adenocarcinoma, Metastatic Castration-Sensitive Prostate Adenocarcinoma
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
RecruitingPhase 1
Evaluating BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Neuroendocrine Tumors
Small Cell Lung Cancer Metastatic or Locally Advanced, Neuroendocrine Cancer
Not yet recruitingPhase 2
Deutenzalutamide and Hormone Therapy Before and After Surgery With Docetaxel Before Surgery for High-Risk Localized or Locally Advanced Prostate Cancer
Prostate Cancer (Adenocarcinoma)
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
McGill University Department of Oncology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Androgen suppression plus radiation therapy in people with Adenocarcinoma of the Prostate, run by Dr. Tamim Niazi at 2 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 18 inclusion and 15 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: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
to determine the rate of local and distance failure at 5 years (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 NCT01255891, which also lists 2 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 9 Dec 2024.