Dose Escalation For INtraprostatic LEsions

What Was Tested

The trial (phase 2) is built around Triptorelin.

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.

It had 1 arm (groups): Prostate SBRT with Focal Boost and Androgen Deprivation Therapy (experimental).

Stereotactic body radiotherapy to 27 Gy in 3 fractions to uninvolved regions of the prostate glad and up to 39 Gy in 3 fractions to mpMRI-defined intraprostatic lesions, with concurrent/adjuvant androgen deprivation therapy (6 months for intermediate risk, 24 months for high risk).

The registry classes the interventions as drug and radiation.

More on the Plan

External beam radiotherapy (RT) in combination with androgen deprivation therapy (ADT) is a standard definitive treatment for localized prostate cancer.

It confers long-term oncologic outcomes equivalent to those of radical prostatectomy.

The current standard approach for prostate RT consists of uniform irradiation of the entire gland.

This technique employs computed tomography (CT) images for planning, in which disease is not readily apparent.

Who Took Part

54 planned participants were the target.

It was open to men only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Histologically confirmed adenocarcinoma of the prostate. Unfavourable intermediate-risk or high-risk localized disease. 3 Tesla prostate MRI done no more than 12 months prior to enrollment. ECOG performance status 0-2. Age ≥ 18 years.

The full record lists 11 inclusion and 11 exclusion criteria; among the exclusions: evidence of pelvic nodal metastases or distant metastases (ajcc stage t1-4 n1 m0-1 or t1-4 n0 m1 disease); androgen deprivation therapy commenced more than 60 days prior to enrollment; other active malignancy within the previous three years (except adequately treated nonmelanomatous carcinoma of the skin or low-grade superficial bladder carcinoma).

How the Study Was Run

Design: single-group and open-label.

Everyone knew when Triptorelin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2023-11-23 with completion listed for 2027-06.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Genitourinary and gastrointestinal toxicity (time frame: Up to 2 years).

It also tracked 2 secondary outcomes, for example Bowel and urinary quality of life and Disease-free survival.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Triptorelin in 54 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Triptorelin compound page, all human trials.