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Adjuvant 3DCRT/IMRT in Combination With Androgen Suppression and Docetaxel for High Risk Prostate Cancer Patients Post-Prostatectomy: A Phase II Trial

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

Adjuvant 3DCRT/IMRT in Combination With Androgen Suppression and Docetaxel for High Risk Prostate Cancer Patients Post-Prostatectomy: A Phase II Trial



- To assess whether the addition of androgen suppression therapy and docetaxel to
adjuvant radiotherapy improves freedom from progression.


- To assess freedom from local-regional progression, distant metastases, disease-free
survival, prostate cancer specific survival, non-prostate cancer specific survival,
overall survival, and time to biochemical (PSA) failure.

- To evaluate treatment-related "acute" and "late" toxicity based on CTCAE v3.0.

- To correlate genomic and proteomic biomarkers with the primary and secondary clinical
endpoints utilizing archival prostatectomy tissue and pretreatment and prospectively
collected serum/plasma.

OUTLINE: This is a multicenter study.

- Androgen suppression therapy: Patients receive a luteinizing hormone-releasing hormone
(LHRH) agonist (leuprolide or goserelin) as an injection AND an oral antiandrogen
(flutamide 3 times daily or bicalutamide once daily) for up to 6 months.

- Radiotherapy: Beginning 8 weeks after the initiation of androgen suppression therapy,
patients undergo 3-dimensional conformal radiotherapy or intensity-modulated
radiotherapy once a day 5 days a week for up to approximately 8 weeks.

- Chemotherapy: Beginning 3-6 weeks after the completion of radiotherapy, patients
receive docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6

After the completion of study treatment, patients are followed every 3 months for 2 years,
every 6 months for 3 years, and then annually thereafter.

Inclusion Criteria


- Pathologically proven adenocarcinoma of the prostate cancer meeting 1 of the
following criteria:

- Gleason ≥ 7and post-operative PSA nadir > 0.2 ng/ml with any pT classification

- Gleason ≥ 8, post-operative PSA nadir ≤ 0.2 ng/ml and ≥ pT3a classification

- Must have undergone radical prostatectomy within the past year

- PSA ≤ 0.2 ng/mL at the time of study registration

- PSA must be obtained within 6 weeks (42 days) prior to study registration

- No lymph node or distant metastases (N0, M0), based upon the following minimum
diagnostic workup:

- History and physical examination within 8 weeks prior to study registration

- Bone scan and CT or MRI of the pelvis and no evidence of osseous metastases on
bone scan within 16 weeks prior to study registration

- No pelvic lymph nodes > 1.5 cm in greatest dimension on CT scan or MRI of the pelvis
within 16 weeks prior to study registration, unless the enlarged lymph node is
biopsied and negative


- Zubrod performance status 0-1

- ANC ≥ 2,000/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention to achieve hemoglobin ≥ 8.0
g/dL is acceptable)

- ALT and AST ≤ 1.5 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 2.5 times ULN

- Total bilirubin ≤ 1.2 times ULN

- No other invasive malignancy within the past 3 years except non-melanomatous skin

- No active, severe co-morbidity, including any of the following:

- Unstable angina and/or congestive heart failure requiring hospitalization within
the past 6 months

- Transmural myocardial infarction within the past 6 months

- Acute bacterial or fungal infection requiring intravenous antibiotics

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy


- HIV testing is not required for study entry

- No prior allergic reaction to the study drug(s)


- No prior systemic chemotherapy for prostate cancer

- More than 3 years since prior chemotherapy for a different cancer

- No prior androgen deprivation for treatment of prostate cancer

- Prior use of hormonal agents, such as finasteride or dutaseride, for treatment
of benign prostatic hypertrophy is allowed

- No prior radiotherapy to the region of the prostate that would result in overlap of
radiotherapy fields

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Freedom from progression at 2 years

Safety Issue:


Principal Investigator

Mark Hurwitz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber/Brigham and Women's Cancer Center


United States: Federal Government

Study ID:




Start Date:

April 2008

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms



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