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Short Course ADT for High Risk Low/Intermediate Risk ARTERA Prostate Cancer

ConditionProstate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorNYU Langone Health

About this trial

For this study, high risk prostate cancer patients with lower risk ARTERA scores will be treated with 6 months of Androgen Deprivation Therapy (ADT) in conjunction with dose escalated radiotherapy to the prostate and nodes. Specifically, patients enrolled in this study will undergo one of several dose-escalated forms of radiotherapy which would include SBRT with or without a brachytherapy boost.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ability to understand and willingness to sign a written informed consent document

18 years of age or older male participants

Biopsy proven prostate cancer meeting at least one of the following high-risk criteria: Gleason score 8-10 OR; Baseline PSA >20 up to and including 40 ng/ml OR; Patients with Gleason score 6-7 remain eligible if the PSA criterion (>20 ng/mL) is met OR; MRI Radiographic stage T1-T3 disease without evidence of nodal involvement

No imaging evidence of nodal metastases on baseline MRI/ CT of the pelvis and PET-PSMA scans

Disqualifiers

Gleason score 6 or 7 in the absence of PSA >20 ng/mL

PSA >40 ng/mL

Prior or concurrent androgen deprivation therapy for prostate cancer of >3 months duration

High Risk ARTERA scores

Trial design

Design model

Single group

Treatments tested in this trial

  • Androgen Deprivation Therapy (ADT)

    Drug

    ADT will be delivered with monthly Degarelix, or Leuprolide injections or daily Relugolix pills which are all standard ADT interventions.

  • Radiotherapy

    Radiation

    Dose-escalated radiotherapy.

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: High-Risk Prostate Cancer Patients with Lower-Risk ARTERA ScoresExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

5-Year Cumulative Incidence of Distant Metastases

Incidence of distant metastases (DM). DM is defined as the first occurrence of radiographic or biopsy-confirmed distant metastatic disease.

Time frame
Up to Year 5

Secondary outcomes

1

Distant Metastasis-Free Survival (DMFS)

Defined as the time from study enrollment to the first occurrence of distant metastasis or death from any cause, whichever occurs first.

Time frame
Up to Year 5
2

Time to Biochemical Failure

Time to biochemical failure will be measured from study enrollment to the date when the Phoenix criterion (PSA nadir + 2 ng/mL) is first met.

Time frame
Up to Year 5
3

Overall Survival (OS)

Defined as the time from study enrollment to death from any cause.

Time frame
Up to Year 5
4

Change in Expanded Prostate Cancer Index Composite-26 (EPIC-26) Score

26-item survey assessing prostate cancer-related symptom domains. Each item is rated on a Likert score. The raw score is the sum of responses and is converted to a standard score from 0-100, where higher scores indicate greater quality of life.

Time frame
Baseline, Year 2

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NYU Langone Health

Lead sponsor

Source ClinicalTrials.gov
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