Adjuvant Androgen Suppression Plus Radiation Therapy for High-Risk Localized Adenocarcinoma Prostate

A Phase II Study of Adjuvant Androgen Suppression Plus Radiation Therapy for High-Risk Localized Adenocarcinoma of the Prostate

To evaluate the efficacy of LHRH agonist with adjuvant pelvic radiation therapy in post radical prostatectomy patients with high risk pathological features for failure. To determine the freedom from biochemical (maintenance of a PSA less than nadir + 2 ng/ml) and clinical progression rate at 5 years.

Study Overview

• Status: Recruiting
• Conditions: Adenocarcinoma of the Prostate
• Intervention / Treatment: Radiation: Androgen suppression plus radiation therapy

Detailed Description

Same as brief Summary

• Study Type: Interventional
• Enrollment (Anticipated): 46
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Tamim Niazi, Dr.; Phone Number: 514-340-8248; Email: tniazi@jgh.mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Recruiting
      • Jewish General Hospital
      • Contact: Beatrice Fournier, Ph.D.; Phone Number: 514-340-8248; Email: bfournier@jgh.mcgill.ca
    • Montreal, Quebec, Canada, H3G 1Y6
      • Recruiting
      • Montreal General Hospital
      • Contact: Luis Souhami, MD; Phone Number: 514-934-8040; Email: luis.souhami@muhc.mcgill.ca
      • Contact: Audrey Fernandes, Ph.D.; Phone Number: 43128 514-934-1934; Email: audrey.fernandes@muhc.mcgill.ca
      • Sub-Investigator: Luis Souhami, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Adenocarcinoma of the prostate treated primarily with radical prostatectomy, pathologically proven to be lymph node negative by pelvic lymphadenectomy (N0) or lymph node status pathologically unknown (undissected pelvic lymph nodes [Nx]), i.e. lymph node dissection is not required;
2. Any type of radical prostatectomy will be permitted, including retropubic, perineal laparoscopic or robotically assisted. If performed, the number of lymph nodes removed per side of the pelvis and the extent of the pelvic lymph node dissection (obturator vs. extended lymph node dissection) should be noted. There is no time limit for the date of radical prostatectomy.
3. A post-radical prostatectomy entry PSA of > 0 and < 1 ng/ml at least 6 weeks after prostatectomy and within 30 days of registration.

4. One of the following pathologic/chemical classifications:

   • T3N0/Nx disease with or without positive surgical margin; or;
   • Gleason score of 8 or more;
   • Pre prostatectomy PSA > 20 ng/ml
5. KPS > 70
6. Age ≥ 18;
7. No distant metastases, based upon the following minimum diagnostic workup:
8. History/physical examination (including digital rectal exam) within 8 wks prior to registration;
9. A CT scan or MRI of the abdomen and pelvis within 120 days prior to registration;
10. Bone scan within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis.

11. Adequate bone marrow function, within 90 days prior to registration, defined as follows:

    • Platelets ≥ 100,000 cells/mm3 based upon CBC;
    • Hemoglobin ≥ 10.0 g/dl based upon CBC
    • AST or ALT < 2 x the upper limit of normal within 90 days prior to registration;
12. Patients must sign a study-specific informed consent prior to study entry.

EXCLUSION CRITERIA:

1. A palpable prostatic fossa abnormality/mass suggestive of recurrence, unless shown by biopsy under ultrasound guidance not to contain cancer;
2. N1 patients are ineligible, as are those with pelvic lymph node enlargement ≥ 1.5 cm in greatest dimension by CT scan or MRI of the pelvis, unless the enlarged lymph node is sampled and is negative;
3. Androgen deprivation therapy started prior to prostatectomy for > 6 months duration;
4. Androgen deprivation therapy started after prostatectomy and prior to registration;
5. Prior pelvic radiotherapy;
6. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 5 years (for example, carcinoma in situ of the oral cavity is permissible);

7. Severe, active co-morbidity, defined as follows:

   • History of inflammatory bowel disease;
   • History of hepatitis B or C; Blood tests are not required to determine if the patient has had hepatitis B or C, unless the patient reports a history of hepatitis.
   • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
   • Transmural myocardial infarction within the last 6 months
   • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
   • Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration;
   • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; AST or ALT are required; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol.
   • Prior allergic reaction to the study drug(s) involved in this protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Adjuvant; Adjuvant suppression plus radiation therapy	Radiation: Androgen suppression plus radiation therapy; Adjuvant androgen suppression plus radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
to determine the rate of local and distance failure at 5 years	5 years

Collaborators and Investigators

• Sponsor: Sir Mortimer B. Davis - Jewish General Hospital
• Collaborators: Abbott
• Investigators: Principal Investigator: Tamim Niazi, MD, McGill University Department of Oncology

Publications and helpful links

General Publications

• Kucharczyk MJ, Tsui JMG, Khosrow-Khavar F, Bahoric B, Souhami L, Anidjar M, Probst S, Chaddad A, Sargos P, Niazi T. Combined Long-Term Androgen Deprivation and Pelvic Radiotherapy in the Post-operative Management of Pathologically Defined High-Risk Prostate Cancer Patients: Results of the Prospective Phase II McGill 0913 Study. Front Oncol. 2020 Mar 12;10:312. doi: 10.3389/fonc.2020.00312. eCollection 2020.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): July 1, 2021
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: December 7, 2010
• First Submitted That Met QC Criteria: December 7, 2010
• First Posted (Estimate): December 8, 2010

Study Record Updates

• Last Update Posted (Actual): December 2, 2022
• Last Update Submitted That Met QC Criteria: November 30, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: high risk localized adenocarcinoma of the prostate
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Adenocarcinoma; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens
• Other Study ID Numbers: McG 0913

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No