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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00969111

Enrollment

Registered

2009-08-31

Start date

2009-08-01

Completion date

2050-08-01

Last updated

2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Proton Radiation, Prostate Cancer

Brief summary

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.

Interventions

RADIATIONIMRT to 45 Gy; prostate bed proton boost of 21.6 CGE

Postop High Risk

RADIATIONProton (prostate bed) to 70.2 CGE

Salvage Non-High Risk

RADIATIONIMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE

Salvage High Risk

RADIATIONProton to 66.6 CGE

Post-Op Non High Risk

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Prostate cancer treated primarily with open, laparoscopic or robotically assisted prostatectomy. * Maximum PSA value of 20 ng/ml.

Exclusion criteria

* 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). * Prior or concurrent cancer, other than non-melanomatous skin cancer, unless disease free for at least 5 years. * Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.

Design outcomes

Primary

Measure	Time frame
The treatment-related rate of acute grade 3 gastrointestinal and genitourinary toxicity following treatment with proton based radiation therapy.	6 months after the end of radiation therapy

Secondary

Measure	Time frame
Collect and analyze quality of life, treatment-related morbidity, disease control and survival outcome parameters	After radiation: every 6 months for 3 years, then annually for 20 years

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSamuel Jean-Baptiste, MD

University of Florida

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026