Androgen Deprivation and Localized Radiotherapy to Metastases in Patients With Oligometastatic Hormone - Sensitive Prostate Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the prostate

- Stage N1, N2, N3, M1a, M1b, M1c disease with ≤ 5 metastatic lesions

- If the diagnosis of metastasis is based solely on imaging CT scan or MRI,
the longitudinal diameter of the lymph node (LN) must be ≥ 2.0 cm

- If the LN is positive on PET or Prostascint scan, the longitudinal diameter
of the LN must be ≥ 1.5 cm on CT scan or MRI

- Measurable disease documented by x-rays, scans, or physical examination within the
past 28 days OR nonmeasurable disease assessed within the past 42 days

- Has received up to 36 weeks of adjuvant androgen deprivation therapy for metastatic
disease OR is planning to receive 36 weeks of adjuvant androgen deprivation therapy

- Patients who are not receiving androgen deprivation therapy at the time of
enrollment undergo androgen deprivation therapy

- Patients who are already receiving androgen deprivation therapy at the time of
enrollment will continue treatment, as described above, until they have received
a total of 36 weeks of treatment

- Patients who have enrolled on study after completion of androgen deprivation
therapy or near the end of their treatment course must have serum testosterone
level at castrate levels (< 50 ng/dL)

- Documented PSA level > 2 ng/mL prior to onset of androgen deprivation

- No disease that is refractory to hormone therapy, as demonstrated by occurrence of 1
of the following while on luteinizing hormone-releasing agonist therapy:

- Increase in PSA by 25% over baseline to at least > 2 ng/mL on two consecutive
PSA measurements

- Increase by 20% in the sum of longest diameters of target measurable lesions
over the smallest sum observed (over baseline if no decrease during therapy)
using the same techniques as were used at baseline

- Clear worsening of any nonmeasurable disease

- Reappearance of any lesion that had disappeared

- Appearance of any new lesion

- No history of brain metastases or current treated or untreated brain metastases

PATIENT CHARACTERISTICS:

- WHO performance status 0-2

- Able to understand the nature of the trial

- No unstable or severe concurrent medical conditions

- No active uncontrolled infection

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Recovered from prior systemic therapy and other previously administered
investigational agents

- No prior radiotherapy or chemotherapy for metastatic disease

- Prior neoadjuvant and adjuvant chemotherapy allowed

- May have received one prior systemic non-chemotherapeutic treatment (i.e.,
immunotherapy, receptor tyrosine kinase inhibitor, antiangiogenic agent, or
differentiating agent) for recurrent or metastatic disease

- More than 2 years since prior adjuvant therapy before androgen deprivation therapy
for metastatic disease AND patient must remain hormone-sensitive

- Sufficient time must have elapsed since other prior investigational agents to ensure
that drug interactions do not occur during this study

- No history of orchiectomy

- Concurrent androgen deprivation therapy for metastatic disease allowed

- Concurrent bisphosphonates allowed at the discretion of the treating physician

- No other concurrent investigational agents