Strategic Endocrine Therapy and Targeted Radiotherapy for Prostate Cancer
ConditionProstate Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of California, San Diego
About this trial
The goal of this clinical trial is to study definitive external beam radiation therapy together with drugs called androgen deprivation therapy (ADT) in patients with prostate cancer. The investigators want to find out if these drugs work the same way if they are given for 6 months or for the usual 18 months in patients who receive also definitive external beam radiotherapy. The investigators will also learn about the safety of the treatments. The main questions the study aims to answer are:
Do patients who get radiation therapy plus 6 months of androgen deprivation therapy need other hormone therapy or develop castration resistance at a higher rate within 5 years, compared to patients who get radiation therapy plus 18 months of androgen deprivation therapy?
Participants will:
Be treated with definitive external beam radiation therapy and receive androgen deprivation therapy for 6 months or 18 months.
Have visits once every 3 months for checkups and tests for at least 5 years. The visits at 3 months, 1 year, and 5 years need to be done in person; all the other visits can be done in person or remotely (telehealth).
Keep a diary of the missed doses of the androgen deprivation therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed adenocarcinoma of the prostate.
Prostate specific antigen ≥ 20 ng/mL
Gleason score 8-10
Clinical stage T3a or higher; imaging can be used to determine T stage if there is macroscopic (gross) extraprostatic extension or invasion of the seminal vesicles or other non-prostate organs
Disqualifiers
Evidence of metastatic disease, including nodal disease beyond the pelvis or distant metastases on imaging.
Clear evidence of regional nodal disease on conventional imaging.
Prior prostatectomy.
Androgen deprivation therapy (Note that participants who have started Androgen deprivation therapy within 90 days prior to randomization can be enrolled.)
Trial design
Design model
Parallel
Treatments tested in this trial
Radiation therapy
RadiationRadiotherapy with short-term androgen deprivation therapy plus, if indicated, an androgen receptor pathway inhibitor.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: RT + ST-ADTExperimental treatment 1 intervention
Group B: RT + LT-ADTActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Failure-free survival
To compare failure-free survival of radiotherapy plus short-term androgen deprivation therapy plus, if indicated, an androgen receptor pathway inhibitor to that of radiotherapy plus long-term androgen deprivation therapy. Participants will be considered to have failure-free survival if they do not experience any of the events in the 5 years after the end of radiation therapy: 1. Death from any cause. 2. Initiation of salvage hormone therapy as defined in the protocol. 3. Castration resistance per the Prostate Cancer Clinical Trials Working Group 3 definition. Castration resistance is defined as biochemical or clinical progression - as defined in the protocol - while serum testosterone is at castrate levels (\<50 ng/dL).
Time frame
Within 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Diego
Lead sponsor
Lantheus
Collaborator
Source ClinicalTrials.gov