Health TrialsbyHealthPanel

Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy

ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorProton Collaborative Group

About this trial

The purpose of this study is to see what effects, good and/or bad, proton radiation, and/or conventional radiation and hormonal therapy (if applicable), has on prostate cancer that has already returned or the risk of prostate cancer returning.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Prostate cancer treated primarily with open, laparoscopic or robotically assisted prostatectomy.

Maximum PSA value of 20 ng/ml.

Disqualifiers

Evidence of distant metastasis (M1).

Prior systemic chemotherapy for any reason.

Previous irradiation to the pelvis that would compromise the ability to deliver the prescribed study treatment.

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE

    Radiation

    Postop High Risk

  • Proton (prostate bed) to 70.2 CGE

    Radiation

    Salvage Non-High Risk

  • IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE

    Radiation

    Salvage High Risk

  • Proton to 66.6 CGE

    Radiation

    Post-Op Non High Risk

Treatment groups

70 Participants
are divided into 4 treatment groups
Group A: Postop Non-High RiskExperimental treatment 1 intervention
Group B: Postop High RiskExperimental treatment 1 intervention
Group C: Salvage Non-High RiskExperimental treatment 1 intervention
Group D: Salvage High RiskExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The treatment-related rate of acute grade 3 gastrointestinal and genitourinary toxicity following treatment with proton based radiation therapy.

Time frame
6 months after the end of radiation therapy

Secondary outcomes

1

Collect and analyze quality of life, treatment-related morbidity, disease control and survival outcome parameters

Time frame
After radiation: every 6 months for 3 years, then annually for 20 years

Other outcomes

Sponsors and contacts

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

Proton Collaborative Group

Lead sponsor

University of Florida Health

Collaborator

Source ClinicalTrials.gov
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