Study on the Role of Hormonal Treatment for Two Dosage Levels of Prostate Radiation Therapy Versus Prostate Radiation Therapy Alone

NCT00223145 | Active Not Recruiting Phase 3

• 2 other identifiers: DC-990-0049,1DC-990-0049
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis of the proposed study would be that, due to the six months of total androgen blockade, which would include neoadjuvant hormonal therapy for four months and concomitant hormonal therapy for two months with irradiation, the investigators could reduce local failure rates for these two dosage levels, namely 70 Gy and 76 Gy. Since increasing the dose to the prostate also seems to reduce local relapse rates, the results of the two hormonal therapy groups would be compared with the results of prostate irradiation at doses of 76 Gy. This study would verify the possibility of compensating a six Gy dosage increase of radiation therapy with six months of hormonal therapy between the 70 Gy and 76 Gy groups who received hormonal therapy, and also match these results with a dose escalation to the prostate of 76 Gy. In the future, this could result in more therapeutic choices, such as reducing the doses of radiation therapy and, consequently, its related complications, if hormonal therapy proves to be beneficial; or rather, to continue in the direction of dose escalation for this intermediate-risk patient group, everything being correlated to the side effects of hormonal therapy and irradiation.

Conditions

Prostate Cancer

Keywords

Prostate adenocarcinoma; Gleason score <= 6 and PSA 10-20; Gleason score = 7 and PSA <=20

Outcome Measures

Primary Outcomes (1)

• Interval before biochemical failure

  10 years

Secondary Outcomes (2)

• Toxicity of irradiation

  10 years

• Survival

  10 years

Study Arms (3)

Arm 1

EXPERIMENTAL

Androgen blockade for 6 months + Radiotherapy 70 Gy

Radiation: Radiotherapy 70 Gy; Drug: Androgen blockade

Arm 2

EXPERIMENTAL

Androgen blockade for 6 months + Radiotherapy 76 Gy

Radiation: Radiotherapy 76 Gy; Drug: Androgen blockade

Arm 3

ACTIVE COMPARATOR

Radiotherapy alone with 76 Gy

Radiation: Radiotherapy 76 Gy

Interventions

Radiotherapy 70 Gy RADIATION

Radiotherapy to the prostate

Arm 1

Radiotherapy 76 Gy RADIATION

Radiotherapy to the prostate

Arm 2; Arm 3

Androgen blockade DRUG

Duration : 6 months

Also known as: Bicalutamide 50 mg, Goserelin 10.8 mg

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with stage T1 or T2 untreated adenocarcinoma of the prostate, with a Gleason score that is less than or equal to 6, as well as a prostate-specific antigen (PSA) between 10-20 (intermediate risk) or patients with stage T1 or T2 untreated adenocarcinoma of the prostate, with a Gleason score that is equal to 7, as well as a PSA equal to or less than 20 (intermediate risk).
• Performance status score of 0-1
• Patients must sign a consent form before starting the study.
• No evidence of regional disease
• Patients with a previous history of cancer are eligible on the condition that they have been disease-free for more than five years.
• Non-invasive epidermoid cancers of the skin are eligible.
• The patient must be available for treatments and follow-up visits.
• No evidence of metastatic disease, confirmed by a negative bone scan.

You may not qualify if:

• Severe medical or psychiatric problems that may compromise study compliance
• Chronic hepatic disease; abnormal hepatic function, i.e. aspartate aminotransferase and alanine aminotransferase \> 1.5 times the upper normal limit.

Sponsors & Collaborators

• Abdenour Nabid: lead
• AstraZeneca: collaborator

Study Sites (1)

Centre de Recherche Clinique du CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (1)

• Nabid A, Carrier N, Vigneault E, Van Nguyen T, Vavassis P, Brassard MA, Bahoric B, Archambault R, Vincent F, Bettahar R, Wilke D, Souhami L. Androgen deprivation therapy and radiotherapy in intermediate-risk prostate cancer: A randomised phase III trial. Eur J Cancer. 2021 Jan;143:64-74. doi: 10.1016/j.ejca.2020.10.023. Epub 2020 Dec 3.

  PMID: 33279855 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

bicalutamide; Goserelin

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)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Abdenour Nabid, MD

  CRC - CHUS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 22, 2005
• Study Start: December 1, 2000
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 27, 2025

Record last verified: 2025-01

Locations

CA (1)