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Prostate CancerPhase 3PCS IVNCT00223171

Duration of Androgen Blockade Combined With Pelvic Irradiation in Prostate Cancers

A Phase 3 study testing Androgen blockade + radiation therapy in people with Prostate Cancer, run by Université de Sherbrooke at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The objective of this study is to use as a reference the 36-month duration of hormonal therapy according to the European Organization for Research of the Treatment of Cancer (EORTC protocol 22863) : namely one-month of total androgen blockade followed by a luteinizing hormone releasing hormone (LHRH) agonist, all for… 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?
Androgen blockade + radiation therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
630 participants
Where
1 siteCanada
Study dates
Oct 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

  • To have at least one of the following three risk factors:
  • Tumour classified T3 or T4
  • Gleason score 8-10
  • Prostate-specific antigen (PSA) level > 20
  • Performance status score of 0-1.
  • Patients must sign a consent form before the start of the study.
Show all 12Show fewer
  • No evidence of regional disease: clinically negative regional adenopathies are revealed by imaging (computed axial tomography [CAT] scan, magnetic resonance imaging [MRI], lymphography) or surgical staging or negative pelvic node dissection.
  • No distant metastasis. These patients must all have a negative bone scan 12 weeks prior to randomization.
  • Hormonal therapy is allowed up to a maximum of two months before the consent form is signed, as long as the initial work-up was done, including having the requested deadlines respected.
  • Patients with a previous history of cancer are eligible on the condition that they have not had any disease progression for more than five years.
  • The patient must be available for treatments and follow-up visits.
  • Treatments must start in the three weeks following randomization.

Who cannot join

  • Severe medical or psychiatric problems that could compromise study compliance.
  • Chronic hepatic disease, abnormal hepatic functions, i.e. aspartate aminotransferase, alanine aminotransferase > 1.5 times the upper normal limit.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Centre de Recherche Clinique du CHUS

    Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

About this study

Official title: Randomized, Multicentre, Phase III Study: Assessment of the Duration of Androgen Blockade Combined With Pelvic Irradiation in High-risk Prostate Cancers

The objective of this study is to use as a reference the 36-month duration of hormonal therapy according to the European Organization for Research of the Treatment of Cancer (EORTC protocol 22863) : namely one-month of total androgen blockade followed by a luteinizing hormone releasing hormone (LHRH) agonist, all for three years, combined with pelvic and prostate irradiation; this arm is currently considered to be a standard for high-risk prostate cancers. The proposed study intends to challenge the duration of hormonal therapy and verify whether the five-year outcomes in favour of combined treatment in regard to survival (79% versus 62%) and local control (85% versus 48%) can be transposed for hormonal therapy that is half as long, namely 18 months, with the possibility of hormone salvage therapy in the event of biochemical and/or clinical failure (local, regional, or distant); this applies to both arms. The proposed study will compare survival in the two groups and evaluate in each one the total duration of initial hormonal therapy, followed by initial hormonal therapy combined with salvage hormonal therapy, the duration of salvage hormonal therapy until hormonal therapy resistance, and the side effects of this hormonal therapy, with everything being related to an assessment of the quality of life of these patients.

Conditions
Prostate Cancer
Being tested
Androgen blockade + radiation therapy
Keywords
Stage T3 T4, PSA > 20, Gleason Score > 7
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 blockade + radiation therapyDrug

    Androgen blockade + radiation therapy

Study groups in NCT00223171
Study groupRoleWhat they receive
Arm 1 : 36 months AB + RTActive comparatorAndrogen blockade : 36 months of androgen blockade : bicalutamide 50 mg die for one month, goserelin 10.8 mg x 12 Q 3 months + radiation therapy : pelvis 44 grays , prostate 70 grays (2 grays/fraction)
Receives: Drug: Androgen blockade + radiation therapy
Arm 2 : 18 months AB + RTExperimentalAndrogen blockade 18 months : bicalutamide 50 mg die for one month, goserelin 10.8 mg x 6 Q 3 months + radiation therapy ( pelvis 44 grays , prostate 70 grays ,2 grays/fraction)
Receives: Drug: Androgen blockade + radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Specific survival

    Measured: 10 years

  2. Overall survival

    Measured: 10 years

  3. Treatment morbidity induced versus quality of life based on duration of hormonal therapy

    Measured: 10 years

Secondary outcomes (4)

  1. Disease-free survival

    Measured: 10 years

  2. Site of tumour relapse

    Measured: 10 years

  3. Interval until first biochemical failure

    Measured: 10 years

  4. Interval until second biochemical failure during salvage androgen suppression (hormone-resistant tumour)

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2005 (estimated)
  2. Study startOct 2000
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
630 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00223171
Sponsor's protocol ID
DC-990-0056,1
Other IDs
DC-990-0056
Acronym
PCS IV
Status last verified
Jan 2025
First submitted
13 Sep 2005
Last updated
27 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Androgen blockade + radiation therapy in people with Prostate Cancer, run by Université de Sherbrooke 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 12 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?

Specific survival (time frame: 10 years). The study lists 3 primary outcomes in all. 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 NCT00223171.

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.

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