Hypo-fractionated Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate Cancer

This study is investigating two ways to treat intermediate-risk prostate cancer: proton radiation therapy alone, or proton radiation therapy combined with Androgen Suppression Therapy (LHRH agonist therapy). The goal is to understand the benefits and risks of adding Androgen Suppression Therapy to proton radiation. You might be eligible if you are a man aged 18 or older with prostate cancer that is considered intermediate risk for returning, based on your Gleason Score, PSA levels, or T stage. The study aims to enroll 192 participants and will measure how well each treatment works by looking at health outcomes (morbidity) over several years. The current status of this study is unclear.

Study design: This interventional study plans to enroll 192 men with prostate cancer. It compares two treatment methods: proton radiation therapy alone versus proton radiation therapy with Androgen Suppression Therapy.
What's involved: Participants will receive either 28 treatments of proton radiation over 5.5-6.5 weeks, or 45 treatments of IMRT radiation over 9-10 weeks. If assigned to the combination therapy, Androgen Suppression Therapy will start 8-10 weeks before radiation and continue for a total of 6 (+/- 2) months.
Compensation: Not stated in the trial record.
Follow-up: Morbidity outcomes will be measured after the first 100 patients have had at least three years of follow-up, and then every year after that.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Hypo-fractionated Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate Cancer

Recruiting

PHASE3Ages 18+InterventionalTreatment

Proton Collaborative Group

~192 participants

Updated 2025-09-04 on ClinicalTrials.gov

What's tested:RadiationAndrogen Suppression Therapy

At a glance

Recruiting sites

4 of 4 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Morbidity Outcomes

Measured over after the initial 100 patients have had a median follow up of at least three years and then every year.

Conditions

Prostate Cancer

Where it's being run

4 sites across 4 states

Arizona1

Illinois1

Oklahoma1

Virginia1

Study leadership

Carlos Vargas, MD · PRINCIPAL_INVESTIGATOR · Proton Collaborative Group

Who to contact

: Clinical Trials Office - All Mayo Clinic Locations

855-776-0015 (toll free)

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Histologically confirmed prostate adenocarcinoma (within 365 days of randomization) at intermediate risk for reoccurrence determined by at least one of the following: Gleason Score 7, PSA \> = 10 and \< = 20, T stage T2b - T2c

Clinical stages T1-T2c N0 M0 as staged by the treating investigator. (AJCC Criteria 7th Ed.- appendix III).

Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason score must be in the range of 2-7. \> 6 cores are strongly recommended.

PSA values \< = 20 ng/ml within 90 days prior to randomization. Obtained prior to biopsy or at least 21 days after prostate biopsy.

ECOG performance status 0-1 (appendix II) assessed within 90 days of randomization.

Patients must sign IRB approved study specific informed consent.

Patients must complete all required pre-entry tests listed in section 4.0 within the specified time frames.

Patients must be able to start treatment within 56 days of randomization.

Patients must be at least 18 years old.

For brachytherapy, an IPSS ≤ 21, or ≤ 17 if patient is on medications to improve urination.

For brachytherapy, prostate volume must be less than 55cc prior to AS.

Exclusion

Pelvic lymph nodes \> 1.5 cm in greatest dimension unless the enlarged lymph node is biopsied and negative.

Previous prostate cancer surgery to include: prostatectomy, hyperthermia and cryosurgery.

Previous pelvic radiation for prostate cancer.

Previous androgen suppression therapy for prostate cancer.

Active rectal diverticulitis, Crohn's disease affecting the rectum or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed).

Prior systemic chemotherapy for prostate cancer.

History of proximal urethral stricture requiring dilatation.

Current and continuing anticoagulation with warfarin sodium (Coumadin), heparin, low- molecular weight heparin, Clopidogrel bisulfate (Plavix), or equivalent (unless it can be stopped to manage treatment related toxicity or to have a biopsy if needed).

Major medical, addictive or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (Consent by legal authorized representative is not permitted for this study).

Evidence of any other cancer within the past 5 years and \< 50% probability of a 5 year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed).

History of myocardial infarction within the last 6 months.

What this trial measures

Morbidity Outcomesafter the initial 100 patients have had a median follow up of at least three years and then every year.
To determine if androgen suppression along with radiation therapy will result in a higher freedom from failure (FFF) than radiation therapy without androgen suppression. Freedom from failure (FFF): The events for FFF will be the first occurrence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (PSA ≥ 2 ng/ml over the current nadir PSA) (45) discounting bounces per investigator discretion, or the start of salvage therapy including androgen suppression

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