AzTrials
AzTrials

Prostate Cancer (Adenocarcinoma)Phase 3PCS-XIINCT06855589

Optimal Duration of Hormonal Therapy for Unfavorable Intermediate-risk Prostate Cancer Patients: 6 Versus 12 Months.

A Phase 3 study testing 6 months of Eligard, 12 months of Eligard and prostate SBRT or prostate brachytherapy with radiation therapy in people with Prostate Cancer (Adenocarcinoma), run by Charles LeMoyne Hospital at 5 sites in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Patients with unfavorable intermediate-risk prostate cancer will be randomized between 6 versus 12 months of hormone therapy with radiation therapy. Patients may choose to receive hypofractionated radiation therapy or hypofractionated radiation therapy with high-dose rate brachytherapy. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer (Adenocarcinoma)
What is being tested?
6 months of Eligard, 12 months of Eligard and prostate SBRT or prostate brachytherapy with radiation therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
5 sitesCanada
Study dates
Mar 2025to Mar 2034
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Histologically confirmed adenocarcinoma of the prostate diagnosed within 6 months prior to randomization, (if longer than 6 months, needs to be approved by the central Principal Investigator).
  • 2. Patient has been classified as unfavorable intermediate risk as defined by one or more of the following criteria :
  • ≥ 2 of the following:
  • CT2b-cT2c
  • Gleason score 7 (3+4) or (4+3)
  • PSA 10-20 ng/mL
Show all 22Show fewer
  • Gleason Score 7 (4+3)
  • ≥ 50% biopsy cores positive
  • 3. Imaging, including CT scan and bone scan (with radiographs of suspicious areas) must be performed within 120 days prior to randomization and be 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 initiation of therapy.
  • 4. Pelvic and para-aortic lymph nodes must be negative on CT scan or MRI of the abdomen and pelvis performed within 120 days prior to randomization. For patients who have started androgen suppression prior to randomization, CT or MRI may be done after the start of therapy, provided it is done no more than 28 days following the start of androgen suppression therapy.
  • Any lymph node appearing > 1.5 cm on CT or MRI must be histologically negative by either needle aspiration or lymph node dissection performed within 12 weeks prior to randomization.
  • 5. Patients will have had a PSA test done around the time of diagnosis. This PSA test could be repeated within 28 days prior to randomization. The PSA value used to confirm unfavorable intermediate 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 the patient has initiated hormone therapy prior to randomization.
  • 6. The patient may have received prior androgen suppression therapy provided that androgen suppression therapy started no more than 28 days prior to randomization.
  • 7. The patient must not have received any cytotoxic anti-cancer therapy for prostate cancer prior to randomization. Patients may have received treatment with a 5-alpha-reductase inhibitor (e.g. Finasteride) for benign prostate hyperplasia (BPH), but must discontinue its use prior to randomization.
  • 8. ECOG performance status must be 0 or 1. 9. Hematology and biochemistry laboratory requirements must 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 10. As it is unknown whether these treatments may affect an unborn child, adequate birth control measures should be used by the participant or his sexual partner(s) (if of reproductive potential while participating in this study).
  • 11. Patient consent must be obtained according to local institutional and/or University Human Experimentation Committee requirements. It will be the responsibility of the local participating investigators to obtain the necessary local clearance, and to indicate in writing that such clearance has been obtained, before the trial can commence in that centre.
  • 12. Patients must be available for treatment and follow-ups. Investigators must ensure that the patients admitted on to this trial will be available for complete documentation of the treatment, adverse events, and follow-up visits.
  • 13. Prostate size must be ≤ 75 cc.

Who cannot join

  • 1. 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.
  • 2. The presence of small-cell or transitional-cell carcinoma in the biopsy specimen.
  • 3. Patients who received previous chemotherapy for carcinoma of the prostate. 4. Patients who had prior surgical treatment for carcinoma of the prostate apart from trans-urethral resection, including bilateral orchiectomy.
  • 5. 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.
  • 6. Patients with serious non-malignant disease resulting in a life expectancy of less than 3 years.
  • 7. Other serious illnesses, psychiatric or medical conditions 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] would also NOT be eligible for the study.
  • 8. Known hypersensitivity to any protocol-indicated study medications. 9. Presence of bilateral hip replacement prostheses. 10. Patients with a 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.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Georges Wakil, MDCM, FRCPC, DABR contact

450-466-5000 ext. 5650

georges.wakil.med@ssss.gouv.qc.ca

Tamim Niazi, MDCM, FRCPC contact

514-340-8288

tamim.niazi@mcgill.ca

5 sites in 1 country

Canada5 sites

  • Hôpital de Gatineau

    Gatineau, Quebec, J8P7H2

    Steven Tisseverasinghe, MD, FRCPC, 819-966-6100, steven.tisseverasinghe.med@ssss.gouv.qc.ca

  • Hôpital Charles LeMoyne

    Longueuil, Quebec, J4V2H1

    Georges Wakil, MDCM, FRCPC, 450-466-5650, georges.wakil.med@ssss.gouv.qc.ca

  • Hôpital Maisonneuve-Rosemont

    Montreal, Quebec, H1T2M4

    Peter Vavassis, MD, FRCPC, 514-252-3400, peter.vavassis.med@ssss.gouv.qc.ca

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

    Tamim Niazi, MDCM, FRCPC, 514-340-8288, tamim.niazi@mcgill.ca

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H5H3

    Abdenour Nabid, MD, FRCPC, 819-346-1110, abdenour.nabid.med@ssss.gouv.qc.ca

Other trials in Canada

About this study

Official title: Phase III Study of Hypofractionated, Dose Escalation Radiotherapy and Brachytherapy for Intermediate-risk Adenocarcinoma of the Prostate with 6 Versus 12 Months of Hormonal Manipulation

Patients with unfavorable intermediate-risk prostate cancer will be randomized between 6 versus 12 months of hormone therapy with radiation therapy. Patients may choose to receive hypofractionated radiation therapy or hypofractionated radiation therapy with high-dose rate brachytherapy. Hypofractionated radiation therapy refers to radiation therapy given fewer treatments, however higher doses per treatment.

Read the detailed description

A total of 400 patients with unfavorable intermediate-risk prostate cancer will be randomized into 2 arms: The first arm will receive the standard 6-month duration of hormone therapy with concomitant radiation therapy. The second arm will receive 12 months with concomitant radiation therapy. Radiation treatment will consist of either concomitant prostate SBRT to a dose of 40 Gy/5fractions over 2 weeks or a combination of external beam radiotherapy dose of 25 Gy in 5 fractions with a high-dose rate brachytherapy boost of 15 Gy. The choice of radiation treatment will be to the investigator's discretion..Patients will be stratified according to the number of intermediate-risk factors and according to the radiation therapy type.

Being tested
6 months of Eligard, 12 months of Eligard, prostate SBRT or prostate brachytherapy with radiation therapy
Keywords
prostate cancer, hormone therapy, stereotactic radiation therapy, brachytherapy
Medical subject headings
Prostatic Neoplasms, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 6 months of EligardDrug

    Total of two 3-month injections of a LHRH agonist for total duration of 6 months

  • 12 months of EligardDrug

    Total of four 3-month injections of a LHRH agonist for total duration of 12 months

  • prostate SBRT or prostate brachytherapy with radiation therapyRadiation

    Patients may receive prostate stereotactic body radiation therapy or a combination of high-dose rate brachytherapy with radiation therapy; as per the treating physician's preference

Study groups in NCT06855589
Study groupRoleWhat they receive
6 months of hormone therapyActive comparatorPatients will receive a total of two 3-month injections of a LHRH agonist
12 months of hormone therapyExperimentalPatients will receive a total of four 3-month injections of a LHRH agonist
Receives: Drug: 12 months of Eligard; Radiation: prostate SBRT or prostate brachytherapy with radiation therapy

What is being measured

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

  1. biochemical progression-free survival

    rate of survival without a biochemical relapse. The definition of biochemical relapse is the PSA nadir + 2. The rates of biochemical relapse will be compared between the patients receiving 6 months vs 12 months of hormonal therapy.

    Measured: 5 years

Secondary outcomes (4)

  1. overall survival

    rate of survival (death due to any cause)

    Measured: 5 years

  2. biochemical progression-free survival

    rate of survival without a biochemical relapse. The definition of biochemical relapse is the PSA nadir + 2. The rates of biochemical relapse will be compared between patients receiving stereotactic body radiation therapy (SBRT) vs hypofractionated radiation therapy with high-dose rate brachytherapy.

    Measured: 5 years

  3. disease-specific survival

    compare death rates due to prostate cancer between patients that received 6 months of hormone therapy versus those that received 12 months of hormone therapy.

    Measured: 5 years

  4. CTCAE version 5 acute and late toxicity

    Acute and delayed toxicity differences measured by CTCAE version 5, at or before 90 days for the acute and 90-180 days and after for the delayed toxicity.

    Measured: 5 years

Timeline

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

  1. First posted4 Mar 2025
  2. Study startMar 2025 (estimated)
  3. Primary completionMar 2033 (estimated)
  4. Study completionMar 2034 (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
Parallel groups
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06855589
Sponsor's protocol ID
PCS-XII
Acronym
PCS-XII
Status last verified
Feb 2025
First submitted
11 Feb 2025
Last updated
4 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 6 months of Eligard, 12 months of Eligard and prostate SBRT or prostate brachytherapy with radiation therapy in people with Prostate Cancer (Adenocarcinoma), run by Charles LeMoyne Hospital at 5 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 22 inclusion and 8 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: opening soon, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

Contact Georges Wakil, MDCM, FRCPC, DABR (450-466-5000 ext. 5650, georges.wakil.med@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

biochemical progression-free survival (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 NCT06855589.

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 4 Mar 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in