Conformal Radiotherapy (CRT) Alone Versus CRT Combined With HDR BT or Stereotactic Body Radiotherapy for Prostate Cancer

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to compare the outcomes of conventionally fractionated conformal radiotherapy with CF-CRT combined with either high-dose-rate brachytherapy or stereotactic body radiotherapy for intermediate or high-risk prostate cancer patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maria Sklodowska-Curie Institute - Oncology Center; Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
• Treatments: Androgens

Criteria

Inclusion Criteria:

1. Pathologically proven adenocarcinoma of the prostate

2. Clinical stage T1-T3a (Intermediate or high risk features according to NCCN criteria)

3. No evidence of nodal or distant spread as determined by chest X-ray, bone scan and abdominal ultrasound or CT-scan or other investigations such as Positron Emission Tomography [PET] scan if required

4. No evidence of bulky spread beyond the capsule of the prostate, no seminal vesicle involvement assessed by TRUS or MRI of pelvis.

5. Good performance status (ZUBROD <2, Karnofsky index >=80%).

6. No contradictions for spinal anesthesia.

7. No contradictions for hormonal treatment (androgen deprivation).

8. Adequate bone marrow, renal and liver function.

9. Life expectancy in excess of 5 years.

10. No prior malignancy, except basal or squamous cell skin cancer.

11. Informed consent for participation in the study (confirmed by the signature together with the standard medical consent form for radiotherapy within the pelvis)

Exclusion Criteria:

1. Different histology than adenocarcinoma.

2. Previous or concurrent malignancy, with the exception of basal cell carcinoma of the skin.

3. Locally advanced disease: bulky T3a and/or T3b.

4. Presence of metastatic disease (nodal and/or distant).

5. PSA >100ng/ml

6. Any previous therapy other than hormonal treatment.

7. Concurrent uncontrolled medical conditions.

8. Medical or psychiatric conditions that compromise the patient's ability to give informed consent.

9. Withdrawal of informed consent.

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