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

A

Abdenour Nabid

Status and phase

Unknown
Phase 3

Conditions

Prostate Cancer

Treatments

Radiation: Radiotherapy 76 Gy
Drug: Androgen blockade
Radiation: Radiotherapy 70 Gy

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00223145
DC-990-0049
DC-990-0049,1

Details and patient eligibility

About

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.

Enrollment

600 patients

Sex

Male

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

600 participants in 3 patient groups

Arm 1
Experimental group
Description:
Androgen blockade for 6 months + Radiotherapy 70 Gy
Treatment:
Drug: Androgen blockade
Radiation: Radiotherapy 70 Gy
Arm 2
Experimental group
Description:
Androgen blockade for 6 months + Radiotherapy 76 Gy
Treatment:
Drug: Androgen blockade
Radiation: Radiotherapy 76 Gy
Arm 3
Active Comparator group
Description:
Radiotherapy alone with 76 Gy
Treatment:
Radiation: Radiotherapy 76 Gy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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