RightFit
RecruitingPhase 3

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

Phase III Study of Image Guided Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Adenocarcinoma of the Prostate

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares 28 proton beam radiation treatments alone with the same radiation plus treatment to lower male hormones. It is for men with prostate cancer that has not spread and has a medium risk of coming back. The study looks at the good and bad effects of both treatments.

The purpose of this study is to compare the effects, good and/or bad of two treatment methods on subjects and their cancer. Proton beam radiation therapy is one of the treatments for men with prostate cancer who have localized disease. The benefit of the combination with androgen suppression is not completely understood. This study will compare the use of hypofraction proton therapy (28 treatments) alone to proton therapy with androgen suppression therapy.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old and have prostate cancer confirmed by a tissue sample within 365 days before being assigned to a study group.
  • Have cancer that has not spread, at stage T1–T2c, and a medium risk of coming back: a Gleason score of 7, PSA of 10–20, or stage T2b–T2c.
  • Have a Gleason score of 2–7. This score shows how abnormal the cancer cells look.
  • Have a PSA blood test result of 20 ng/ml or less within 90 days before group assignment. The test must be before the prostate biopsy or at least 21 days after it.
  • Be fully active or able to do light work, as checked within 90 days before group assignment.
  • Sign the study consent form, finish all required entry tests on time, and be able to start treatment within 56 days after group assignment.
  • For brachytherapy, which places radiation inside the body, have a urinary symptom score of 21 or less, or 17 or less if taking medicine to help urination.
  • For brachytherapy, have a prostate smaller than 55 cc before hormone-lowering treatment.

Who can't join

  • Have pelvic lymph nodes larger than 1.5 cm, unless a tissue sample shows no cancer.
  • Have had prostate cancer treatment with prostate removal, heat or freezing treatments, pelvic radiation, hormone-lowering therapy, or chemotherapy.
  • Have active diverticulitis affecting the rectum, Crohn’s disease affecting the rectum, or ulcerative colitis. These conditions cause swelling or irritation in the bowel.
  • Have had narrowing near the bladder in the tube that carries urine out of the body that needed a procedure to widen it.
  • Take ongoing blood-thinning medicine, such as Coumadin, heparin, or Plavix, that cannot be stopped if needed for side effects or a biopsy.
  • Have a major medical, addiction, or mental health condition that the study doctor believes would prevent consent, treatment, or follow-up. Another person cannot give consent for you.
  • Have had another cancer within the past 5 years with less than a 50% chance of surviving 5 years. Basal cell or non-invasive squamous cell skin cancer is allowed.
  • Have had a heart attack within the past 6 months.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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.

Study sites (4)

AZ

IL

OK

VA