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

NCT06855589 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: PCS-XII
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 5

Brief 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. Hypofractionated radiation therapy refers to radiation therapy given fewer treatments, however higher doses per treatment.

Conditions

Prostate Cancer (Adenocarcinoma)

Keywords

prostate cancer; hormone therapy; stereotactic radiation therapy; brachytherapy

Outcome Measures

Primary Outcomes (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.

  5 years

Secondary Outcomes (4)

• overall survival

  5 years

• biochemical progression-free survival

  5 years

• disease-specific survival

  5 years

• CTCAE version 5 acute and late toxicity

  5 years

Study Arms (2)

6 months of hormone therapy

ACTIVE COMPARATOR

Patients will receive a total of two 3-month injections of a LHRH agonist

12 months of hormone therapy

EXPERIMENTAL

Patients will receive a total of four 3-month injections of a LHRH agonist

Drug: 12 months of Eligard; Radiation: prostate SBRT or prostate brachytherapy with radiation therapy

Interventions

6 months of Eligard DRUG

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

12 months of Eligard DRUG

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

12 months of hormone therapy

prostate SBRT or prostate brachytherapy with radiation therapy RADIATION

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

12 months of hormone therapy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: patient must have a prostate
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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).
• \. 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
• \. 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.
• \. 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.
• \. 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.
• \. The patient may have received prior androgen suppression therapy provided that androgen suppression therapy started no more than 28 days prior to randomization.
• \. 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.
• \. 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:

You may not qualify if:

• \. 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.
• \. The presence of small-cell or transitional-cell carcinoma in the biopsy specimen.
• \. 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.
• \. 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.
• \. Patients with serious non-malignant disease resulting in a life expectancy of less than 3 years.
• \. 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.
• \. 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.

Sponsors & Collaborators

• Charles LeMoyne Hospital: lead

Study Sites (5)

Hôpital de Gatineau

Gatineau, Quebec, J8P7H2, Canada

Location

Hôpital Charles LeMoyne

Longueuil, Quebec, J4V2H1, Canada

Location

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T2M4, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H5H3, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma

Interventions

luprolide acetate gel depot; Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Georges Wakil, MDCM, FRCPC, DABR

  Hopital Charles Lemoyne

  PRINCIPAL INVESTIGATOR

• Tamim Niazi, MDCM, FRCPC

  Jewish General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Georges Wakil, MDCM, FRCPC, DABR

CONTACT

450-466-5000; georges.wakil.med@ssss.gouv.qc.ca

Tamim Niazi, MDCM, FRCPC

CONTACT

514-340-8288; tamim.niazi@mcgill.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist, MDCM, FRCPC, Principal Investigator, Clinical teaching professor

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: March 4, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2033
• Study Completion (Estimated): March 1, 2034
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)