Prostatic Neoplasms study: Triptorelin Injection
Official title Dose Escalation For INtraprostatic LEsions
ClinicalTrials.gov ID: NCT05851547
What this study is testing
What is Triptorelin Injection?
This is an investigational hormone therapy being studied as a treatment for prostate cancer. It is designed to lower the levels of male hormones in the body that can help prostate cancer cells grow.
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
- The study wants to see if giving fewer, larger doses of radiation safely reduces side effects while still targeting cancer spots.
- Who it's for
- Men with prostate cancer that can be treated with radiation and hormone therapy.
- What's involved
- Participants will receive three large radiation treatments over one week, guided by MRI to focus on tumor areas, plus standard hormone therapy and regular check‑ups.
- Time commitment
- The treatment lasts one week, with follow‑up visits for up to one year to monitor side effects.
- 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
- 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
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Ottawa, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.