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NCT Number: NCT00223145

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Centre de Recherche Clinique du CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Radiotherapy 70 Gy

Radiation

Radiotherapy to the prostate

Radiotherapy 76 Gy

Radiation

Radiotherapy to the prostate

Androgen blockade

Drug

Duration : 6 months

Other names: Bicalutamide 50 mg, Goserelin 10.8 mg

Primary outcomes

  1. Interval before biochemical failure

    Time frame: 10 years

Secondary outcomes

  1. Toxicity of irradiation

    Time frame: 10 years

  2. Survival

    Time frame: 10 years

Sponsors and collaborators

Lead sponsor

Abdenour Nabid

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

Randomized, Multicentre, Phase III Study in Patients With Intermediate-risk T1 T2 Prostate Adenocarcinomas, to Verify the Role of Six Months of Total Androgen Blockade for Two Dosage Levels of Prostate Radiation Therapy (70 Gy and 76 Gy) Versus Prostate Radiation Therapy Alone at 76 Gy

Acronym: PCS III

Important dates

Study start
2000
Primary completion
2026
Study completion
2027
First posted
Sep 22, 2005
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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