Optimal Duration of Hormonal Therapy for Unfavorable Intermediate-risk Prostate Cancer Patients: 6 Versus 12 Months.
NCT ID: NCT06855589
Last Updated: 2025-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
400 participants
INTERVENTIONAL
2025-03-31
2034-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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6 months of hormone therapy
Patients will receive a total of two 3-month injections of a LHRH agonist
No interventions assigned to this group
12 months of hormone therapy
Patients will receive a total of four 3-month injections of a LHRH agonist
12 months of Eligard
Total of four 3-month injections of a LHRH agonist for total duration of 12 months
prostate SBRT or prostate brachytherapy with radiation therapy
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
Interventions
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6 months of Eligard
Total of two 3-month injections of a LHRH agonist for total duration of 6 months
12 months of Eligard
Total of four 3-month injections of a LHRH agonist for total duration of 12 months
prostate SBRT or prostate brachytherapy with radiation therapy
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
Eligibility Criteria
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Inclusion Criteria
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
* 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:
1. Hemoglobin \> 100 g/L
2. Absolute Neutrophils \> 1.5 x 109/L
3. Platelets \> 100 x 109/L
4. 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.
Exclusion Criteria
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.
18 Years
MALE
No
Sponsors
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Charles LeMoyne Hospital
OTHER
Responsible Party
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Georges Wakil
Radiation Oncologist, MDCM, FRCPC, Principal Investigator, Clinical teaching professor
Principal Investigators
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Georges Wakil, MDCM, FRCPC, DABR
Role: PRINCIPAL_INVESTIGATOR
Hopital Charles Lemoyne
Tamim Niazi, MDCM, FRCPC
Role: PRINCIPAL_INVESTIGATOR
Jewish General Hospital
Locations
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Hôpital de Gatineau
Gatineau, Quebec, Canada
Hôpital Charles LeMoyne
Longueuil, Quebec, Canada
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PCS-XII
Identifier Type: -
Identifier Source: org_study_id
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