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

Proton Collaborative Group

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Radiation: Proton to 66.6 CGE; Radiation: IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE; Radiation: IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE; Radiation: Proton (prostate bed) to 70.2 CGE

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT00969111

GU010-18

UFPTI 0902-PR06 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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).
• History of hip replacement.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 4 patient groups

Postop Non-High Risk

Experimental group

Description:

Proton to 66.6 CGE

Treatment:

Radiation: Proton to 66.6 CGE

Postop High Risk

Experimental group

Description:

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

Treatment:

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

Salvage Non-High Risk

Experimental group

Description:

Proton to 70.2 CGE

Treatment:

Radiation: Proton (prostate bed) to 70.2 CGE

Salvage High Risk

Experimental group

Description:

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

Treatment:

Radiation: IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE