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New treatment option for Prostatic Neoplasms
Official title Dose Escalation For INtraprostatic LEsions
ClinicalTrials.gov ID: NCT05851547
What this study is testing
What is Triptorelin Injection?
Triptorelin Injection is an investigational medicine, given as an once-daily, being studied as a potential treatment for prostatic neoplasms.
Also referred to as Androgen Deprivation Therapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- External beam radiotherapy combined with androgen deprivation therapy is a standard treatment option for localized prostate cancer. The current standard involves delivering radiotherapy uniformly throughout the prostate gland in daily fractions, five days per week, for approximately four weeks.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Histologically confirmed adenocarcinoma of the prostate
- Unfavourable intermediate-risk or high-risk localized disease
- Unfavourable intermediate-risk prostate cancer is defined as intermediate-risk prostate cancer [that is, no high-risk features and one or more...
- High-risk localized prostate cancer is defined as at least one of the following: T3a-T3b; Gleason ≥ 8 (grade group 4 or grade group 5); PSA \> 20 μg/L
- 3 Tesla prostate MRI done no more than 12 months prior to enrollment
You likely can't join if
- Evidence of pelvic nodal metastases or distant metastases (AJCC Stage T1-4 N1 M0-1 or T1-4 N0 M1 disease)
- Discordance between pre-enrollment prostate MRI and prostate biopsy findings, defined as biopsy cores with Gleason Gleason ≥ 4+3 (grade group ≥ 3)...
- Androgen deprivation therapy commenced more than 60 days prior to enrollment
- Intention to electively treat the pelvic lymph nodes with radiotherapy
- Other active malignancy within the previous three years (except adequately treated nonmelanomatous carcinoma of the skin or low-grade superficial...
- Prior pelvic radiotherapy
See the full eligibility criteria
- Histologically confirmed adenocarcinoma of the prostate
- Unfavourable intermediate-risk or high-risk localized disease
- Unfavourable intermediate-risk prostate cancer is defined as intermediate-risk prostate cancer [that is, no high-risk features and one or more intermediate-risk factors: T2b-T2c, Gleason 3+4 (grade group 2) or Gleason...
- High-risk localized prostate cancer is defined as at least one of the following: T3a-T3b; Gleason ≥ 8 (grade group 4 or grade group 5); PSA \> 20 μg/L
- 3 Tesla prostate MRI done no more than 12 months prior to enrollment
- ECOG performance status 0-2
- Age ≥ 18 years
- Written informed consent
- The participant has planned androgen deprivation therapy that meets one of the following criteria:
- Patients with intermediate-risk localized prostate cancer who have planned androgen deprivation therapy consisting of up to 6 months of triptorelin with or without bicalutamide; OR patients with high-risk localized...
- Completion of all appropriate investigations prior to enrollment
- Evidence of pelvic nodal metastases or distant metastases (AJCC Stage T1-4 N1 M0-1 or T1-4 N0 M1 disease)
- Discordance between pre-enrollment prostate MRI and prostate biopsy findings, defined as biopsy cores with Gleason Gleason ≥ 4+3 (grade group ≥ 3) adenocarcinoma with no corresponding tumour focus seen on MRI
- Androgen deprivation therapy commenced more than 60 days prior to enrollment
- Intention to electively treat the pelvic lymph nodes with radiotherapy
- Other active malignancy within the previous three years (except adequately treated nonmelanomatous carcinoma of the skin or low-grade superficial bladder carcinoma)
- Prior pelvic radiotherapy
- Contraindication to pelvic radiotherapy
- Any history, past or present, of inflammatory bowel disease
- Unilateral or bilateral hip arthroplasty
- Trans-urethral resection of the prostate (TURP) performed within 6 months of anticipated start date of radiotherapy
- Patients must not concurrently participate in any other therapeutic prostate cancer trial.
The study team makes the final eligibility decision.
Where it's taking place
- Ottawa, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ottawa, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.