Testosterone in Treating Patients With Progressive Prostate Cancer That No Longer Responds to Hormone Therapy

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

RATIONALE: High doses of testosterone may be effective in killing prostate cancer cells that no longer respond to hormone therapy.

PURPOSE: Phase I trial to study the effectiveness of testosterone in treating patients who have progressive prostate cancer that no longer responds to hormone therapy.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed androgen independent metastatic prostate cancer

• Progressive disease manifested by either:

• New osseous lesions by bone scan or a greater than 25% increase in bidimensionally measurable soft tissue disease or the appearance of new sites of disease by MRI or CT scan OR

• Minimum of 3 rising PSA values from baseline that are obtained 1 week or more apart, or 2 rising PSA values more than 1 month apart, where the percentage increase over the range of values is at least 25%

• Castrate state by orchiectomy or gonadotropin-releasing hormone analogues for minimum of 1 year

• Testosterone no greater than 30 ng/mL

• Measurable disease

• Metastatic disease by bone scan, MRI, or CT scan

• Rising PSA values

• If receiving antiandrogen therapy, must have shown progressive disease off treatment

• No active CNS or epidural tumor

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,500/mm^3

• Platelet count greater than 100,000/mm^3

Hepatic:

• Bilirubin less than 2.0 mg/dL

• SGOT less than 3 times upper limit of normal

• PTT less than 14 seconds

Renal:

• Creatinine less than 2.0 mg/dL OR

• Creatinine clearance greater than 60 mL/min

Cardiovascular:

• No New York Heart Association class III or IV cardiac disease

Pulmonary:

• No severe debilitating pulmonary disease

Other:

• No infection requiring IV antibiotics

• No other severe medical problems that would increase risk for toxicity

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Recovered from prior biologic therapy

• No concurrent immunotherapy

Chemotherapy:

• Recovered from prior chemotherapy

• No concurrent chemotherapy

Endocrine therapy:

• See Disease Characteristics

• If no prior orchiectomy, must continue on gonadotropin-releasing hormone analogs to maintain castrate levels of testosterone

• No concurrent finasteride

• No other concurrent hormonal therapy

Radiotherapy:

• Recovered from prior radiotherapy

• No concurrent radiotherapy to an indicator lesion

Surgery:

• See Disease Characteristics

• Recovered from prior surgery

• No concurrent surgery on only measurable lesion

Other:

• At least 4 weeks since other prior investigational anticancer drugs and recovered

• No other concurrent investigational anticancer agents