Hypofractionated Radiation Therapy for Treating Prostate Cancer High-Risk Features Following Radical Prostatectomy

NCT03570827 | Completed Phase 2 DMC FDA Drug

• 3 other identifiers: MC1754NCI-2018-0094317-009199
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

Brief Summary

This phase II trial studies how well hypofractionated radiation therapy works in treating participants with prostate cancer high-risk features following radical prostatectomy. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.

Conditions

Prostate Adenocarcinoma; Stage IIB Prostate Cancer AJCC v8; Stage III Prostate Cancer AJCC v8; Stage IIIA Prostate Cancer AJCC v8; Stage IIIB Prostate Cancer AJCC v8; Stage IIIC Prostate Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• Freedom from failure (FF)

  Will be defined as the first occurrence of clinical failure (local recurrence, regional recurrence, or distant metastasis), the start/re-start of salvage therapy including androgen suppression, and biochemical failure (PSA \>= 0.5 ng/ml).

  Up to 5 years

Other Outcomes (17)

• Development of quality assurance process for prostate proton therapy

  Up to 5 years

• Overall survival at 5 years

  Up to 5 years

• Freedom from biochemical failure (FFBF)

  Up to 5 years

Study Arms (3)

Group I (hypofractionated radiation therapy)

EXPERIMENTAL

Participants undergo hypofractionated radiation therapy over 15-30 minutes every other day over 2 weeks, for 5 treatments.

Radiation: Hypofractionated Radiation Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Group II (radiation therapy, androgen suppression therapy)

EXPERIMENTAL

Beginning 8-10 weeks before radiation therapy, participants receive androgen suppression therapy SC or IM for up to 6 months (at the discretion of the treating physician). Participants then undergo hypofractionated radiation therapy as Group I.

Drug: Androgen Suppression; Radiation: Hypofractionated Radiation Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Group III (radiation therapy, androgen suppression therapy)

EXPERIMENTAL

Participants receive androgen suppression therapy as Group II for up to 18 months (at the discretion of the treating physician), then undergo hypofractionated radiation therapy over 15-30 minutes every other day over 1-2 weeks, for 1-5 treatments.

Drug: Androgen Suppression; Radiation: Hypofractionated Radiation Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Androgen Suppression DRUG

Given androgen suppression therapy

Also known as: Androgen Ablation, androgen deprivation

Group II (radiation therapy, androgen suppression therapy); Group III (radiation therapy, androgen suppression therapy)

Hypofractionated Radiation Therapy RADIATION

Undergo hypofractionated radiation therapy

Also known as: Hypofractionated Radiotherapy, hypofractionation, Radiation, Hypofractionated

Group I (hypofractionated radiation therapy); Group II (radiation therapy, androgen suppression therapy); Group III (radiation therapy, androgen suppression therapy)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Group I (hypofractionated radiation therapy); Group II (radiation therapy, androgen suppression therapy); Group III (radiation therapy, androgen suppression therapy)

Questionnaire Administration OTHER

Ancillary studies

Group I (hypofractionated radiation therapy); Group II (radiation therapy, androgen suppression therapy); Group III (radiation therapy, androgen suppression therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed prostate adenocarcinoma at the time of surgery
• Pathologic stages T2-T3b, N0-Nx-N1, M0-1 as staged by the pathology report (American Joint Committee on Cancer \[AJCC\] criteria 8th edition \[Ed.\])
• One or more high risk features including: seminal vesicle invasion, extracapsular extension, positive margins, or a PSA post surgery between 0.2 and \< 2.0
• PSA values \< 2 ng/ml within 90 days prior to enrollment. Obtained at least 6 weeks after surgery
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2 assessed within 90 days of enrollment
• Patients must sign Institutional Review Board (IRB) approved study specific informed consent
• Patients must complete all required pre-entry tests within the specified time frames
• Patients must be able to start treatment (androgen suppression \[AS\] or radiation) within 120 days of study registration
• Members of all races and ethnic groups are eligible for this trial
• Patients from outside of the United States may participate in the study

You may not qualify if:

• Previous pelvic radiation
• Prior androgen suppression therapy for prostate cancer for more than 6 months
• 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, to have a biopsy if needed, or place markers)
• 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 or decompensated congestive heart failure (CHF) within the last 6 months

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiation Dose Hypofractionation; Radiation

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics; Physical Phenomena

Study Officials

• Carlos E. Vargas, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: June 27, 2018
• Study Start: May 14, 2018
• Primary Completion: May 15, 2025
• Study Completion: May 15, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-08

Locations

US (2)