Prostate CancerPhase 3PCS IIINCT00223145
Study on the Role of Hormonal Treatment for Two Dosage Levels of Prostate Radiation Therapy Versus Prostate Radiation Therapy Alone
A Phase 3 study testing Radiotherapy 70 Gy, Radiotherapy 76 Gy and Androgen blockade in people with Prostate Cancer, run by Abdenour Nabid at 1 site in Canada.
Trial summary
The hypothesis of the proposed study would be that, due to the six months of total androgen blockade, which would include neoadjuvant hormonal therapy for four months and concomitant hormonal therapy for two months with irradiation, the investigators could reduce local failure rates for these two dosage levels, namely… Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Radiotherapy 70 Gy, Radiotherapy 76 Gy and Androgen blockade
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2000to 31 Dec 2027
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with stage T1 or T2 untreated adenocarcinoma of the prostate, with a Gleason score that is less than or equal to 6, as well as a prostate-specific antigen (PSA) between 10-20 (intermediate risk) or patients with stage T1 or T2 untreated adenocarcinoma of the prostate, with a Gleason score that is equal to 7, as well as a PSA equal to or less than 20 (intermediate risk).
- Performance status score of 0-1
- Patients must sign a consent form before starting the study.
- No evidence of regional disease
- Patients with a previous history of cancer are eligible on the condition that they have been disease-free for more than five years.
- Non-invasive epidermoid cancers of the skin are eligible.
- The patient must be available for treatments and follow-up visits.
- No evidence of metastatic disease, confirmed by a negative bone scan.
Who cannot join
- Severe medical or psychiatric problems that may compromise study compliance
- Chronic hepatic disease; abnormal hepatic function, i.e. aspartate aminotransferase and alanine aminotransferase > 1.5 times the upper normal limit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Multicentre, Phase III Study in Patients With Intermediate-risk T1 T2 Prostate Adenocarcinomas, to Verify the Role of Six Months of Total Androgen Blockade for Two Dosage Levels of Prostate Radiation Therapy (70 Gy and 76 Gy) Versus Prostate Radiation Therapy Alone at 76 Gy
The hypothesis of the proposed study would be that, due to the six months of total androgen blockade, which would include neoadjuvant hormonal therapy for four months and concomitant hormonal therapy for two months with irradiation, the investigators could reduce local failure rates for these two dosage levels, namely 70 Gy and 76 Gy. Since increasing the dose to the prostate also seems to reduce local relapse rates, the results of the two hormonal therapy groups would be compared with the results of prostate irradiation at doses of 76 Gy. This study would verify the possibility of compensating a six Gy dosage increase of radiation therapy with six months of hormonal therapy between the 70 Gy and 76 Gy groups who received hormonal therapy, and also match these results with a dose escalation to the prostate of 76 Gy. In the future, this could result in more therapeutic choices, such as reducing the doses of radiation therapy and, consequently, its related complications, if hormonal therapy proves to be beneficial; or rather, to continue in the direction of dose escalation for this intermediate-risk patient group, everything being correlated to the side effects of hormonal therapy and irradiation.
- Conditions
- Prostate Cancer
- Being tested
- Radiotherapy 70 Gy, Radiotherapy 76 Gy, Androgen blockade
- Keywords
- Prostate adenocarcinoma, Gleason score <= 6 and PSA 10-20, Gleason score = 7 and PSA <=20
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiotherapy 70 GyRadiation
Radiotherapy to the prostate
Radiotherapy 76 GyRadiation
Radiotherapy to the prostate
Androgen blockadeDrug
Also called Bicalutamide 50 mg, Goserelin 10.8 mg
Duration : 6 months
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Androgen blockade for 6 months + Radiotherapy 70 Gy Receives: Radiation: Radiotherapy 70 Gy; Drug: Androgen blockade |
| Arm 2 | Experimental | Androgen blockade for 6 months + Radiotherapy 76 Gy Receives: Radiation: Radiotherapy 76 Gy; Drug: Androgen blockade |
| Arm 3 | Active comparator | Radiotherapy alone with 76 Gy Receives: Radiation: Radiotherapy 76 Gy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interval before biochemical failure
Measured: 10 years
Secondary outcomes (2)
Toxicity of irradiation
Measured: 10 years
Survival
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startDec 2000
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abdenour Nabid
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor-investigator, Abdenour Nabid, Université de Sherbrooke
- Investigators
- Abdenour Nabid, MD, Principal investigator, CRC - CHUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00223145
- Sponsor's protocol ID
- DC-990-0049,1
- Other IDs
- DC-990-0049
- Acronym
- PCS III
- Status last verified
- Jan 2025
- First submitted
- 13 Sep 2005
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Nabid A, Carrier N, Vigneault E, Van Nguyen T, Vavassis P, Brassard MA, Bahoric B, Archambault R, Vincent F, Bettahar R, Wilke D, Souhami L. Androgen deprivation therapy and radiotherapy in intermediate-risk prostate cancer: A randomised phase III trial. Eur J Cancer. 2021 Jan;143:64-74. doi: 10.1016/j.ejca.2020.10.023. Epub 2020 Dec 3.
PubMed 33279855
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Multicentre, Phase III Study in Patients With Intermediate-risk T1 T2 Prostate Adenocarcinomas, to Verify the Role of Six Months of Total Androgen Blockade for Two Dosage Levels of Prostate Radiation Therapy (70 Gy and 76 Gy) Versus Prostate Radiation Therapy Alone at 76 Gy
- ClinicalTrials.gov ID
- NCT00223145
- Acronym / sponsor ID
- PCS III / DC-990-0049,1
- Conditions
- Prostate Cancer
- Keywords
- Prostate adenocarcinoma, Gleason score <= 6 and PSA 10-20, Gleason score = 7 and PSA <=20
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Abdenour NabidUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Dec 2000
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 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 hypothesis of the proposed study would be that, due to the six months of total androgen blockade, which would include neoadjuvant hormonal therapy for four months and concomitant hormonal therapy for two months with irradiation, the investigators could reduce local failure rates for these two dosage levels, namely 70 Gy and 76 Gy. Since increasing the dose to the prostate also seems to reduce local relapse rates, the results of the two hormonal therapy groups would be compared with the results of prostate irradiation at doses of 76 Gy. This study would verify the possibility of compensating a six Gy dosage increase of radiation therapy with six months of hormonal therapy between the 70 Gy and 76 Gy groups who received hormonal therapy, and also match these results with a dose escalation to the prostate of 76 Gy. In the future, this could result in more therapeutic choices, such as reducing the doses of radiation therapy and, consequently, its related complications, if hormonal therapy proves to be beneficial; or rather, to continue in the direction of dose escalation for this intermediate-risk patient group, everything being correlated to the side effects of hormonal therapy and irradiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Radiation: Radiotherapy 70 Gy, Drug: Androgen blockadeAndrogen blockade for 6 months + Radiotherapy 70 Gy |
| Arm 2 | Experimental | Radiation: Radiotherapy 76 Gy, Drug: Androgen blockadeAndrogen blockade for 6 months + Radiotherapy 76 Gy |
| Arm 3 | Active comparator | Radiation: Radiotherapy 76 GyRadiotherapy alone with 76 Gy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with stage T1 or T2 untreated adenocarcinoma of the prostate, with a Gleason score that is less than or equal to 6, as well as a prostate-specific antigen (PSA) between 10-20 (intermediate risk) or patients with stage T1 or T2 untreated adenocarcinoma of the prostate, with a Gleason score that is equal to 7, as well as a PSA equal to or less than 20 (intermediate risk).
- Performance status score of 0-1
- Patients must sign a consent form before starting the study.
- No evidence of regional disease
- Patients with a previous history of cancer are eligible on the condition that they have been disease-free for more than five years.
Key exclusion criteria (2 listed)
- Severe medical or psychiatric problems that may compromise study compliance
- Chronic hepatic disease; abnormal hepatic function, i.e. aspartate aminotransferase and alanine aminotransferase > 1.5 times the upper normal limit.
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 |
|---|---|---|
| Radiotherapy 70 GyRadiotherapy to the prostate | Radiation | Arm 1 |
| Radiotherapy 76 GyRadiotherapy to the prostate | Radiation | Arm 2, Arm 3 |
| Androgen blockadeAlso: Bicalutamide 50 mg, Goserelin 10.8 mgDuration : 6 months | Drug | Arm 1, Arm 2 |
Primary outcome
Interval before biochemical failure
Time frame: 10 years
2 secondary outcomes
Toxicity of irradiation
Time frame: 10 years
Survival
Time frame: 10 years
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 27 Jan 2025.
- Derived from this study: PubMed 33279855Nabid A, Carrier N, Vigneault E, Van Nguyen T, Vavassis P, Brassard MA, Bahoric B, Archambault R, Vincent F, Bettahar R, Wilke D, Souhami L. Androgen deprivation therapy and radiotherapy in intermediate-risk prostate cancer: A randomised phase III trial. Eur J Cancer. 2021 Jan;143:64-74. doi: 10.1016/j.ejca.2020.10.023. Epub 2020 Dec 3.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Abdenour Nabid, MD principal investigator
CRC - CHUS
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 Radiotherapy 70 Gy, Radiotherapy 76 Gy and Androgen blockade in people with Prostate Cancer, run by Abdenour Nabid 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 8 inclusion and 2 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 27 Jan 2025. 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?
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?
Interval before biochemical failure (time frame: 10 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 NCT00223145, which also lists 1 linked publication.
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 27 Jan 2025.