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Enzalutamide and PDS01ADC in PET Positive Recurrent Prostate Cancer (pprPC) Without Testosterone Lowering Therapy

ConditionsProstate CancerRecurrent Prostate CancerPET Positive
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-120
SponsorNational Cancer Institute (NCI)

About this trial

Background:

Prostate cancer may return after treatment in 30,000 to 50,000 people each year. There is no clear best way to treat these people. Better treatments are needed.

Objective:

To test a study drug (enzalutamide), both alone and combined with a second drug (PDS01ADC), in people with prostate cancer that returned after treatment.

Eligibility:

People aged 18 years and older with prostate cancer that returned after treatment.

Design:

Participants will be screened. They will have a physical exam, with blood tests. All their urine will be collected for 24 hours. They will have imaging scans of their chest, abdomen, pelvis, and bones. Their ability to perform everyday activities will be assessed. They may opt to give a stool sample.

Participants will be treated in 4-week cycles.

Enzalutamide is a pill taken by mouth once a day, every day. All participants will be given a supply of this drug to take at home.

PDS01ADC is injected under the skin once a month, on the first day of each cycle. Half of the participants will receive both drugs.

All participants will visit the clinic once a month. Each visit should last no more than 8 hours. Blood and urine tests will be repeated.

All participants will receive the study treatment for 3 cycles. Some participants may need 3 more cycles of treatment with enzalutamide only. This re-treatment can be done only once.

Participants will have a follow-up visit 1 month after they finish treatment. After that, they will have visits every 6 weeks for up to 5 years. Imaging scans and blood tests will be repeated.

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Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant must provide documentation of histologic or cytological confirmation of prostate cancer or tumor sample for diagnosis confirmation. Note: in the absence of pathology or documentation, participant must have a rising PSA, PSMA+ disease, and his history consistent with prostate cancer as documented by the investigator.

History of primary treatment for prostate cancer (either surgery or radiation).

Prostate-specific antigen (PSA) doubling time within less than 12 months.

Testosterone >100 ng/dL.

Disqualifiers

Evidence of soft tissue disease on CT scan (or magnetic resonance imaging (MRI) if assessment cannot be done by CT scan) per RECIST 1.1 criteria (lymph nodes up to 2.0 cm in the shortest dimension are allowed).

Evidence of bone lesions on Tc99 bone scan.

History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs or imaging agents used in the study.

Any medical condition that requires chronic systemic steroid therapy, or any other form of immunosuppressive medication (inhaled and topical steroids are permitted).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Enzalutamide

    Drug

    Enzalutamide at 160 mg once daily on every day of the cycle (every 28 days)

  • PDS01ADC

    Drug

    PDS01ADC at 12.0 microgram/kg by subcutaneous injection (every 28 days)

Treatment groups

65 Participants
are divided into 2 treatment groups
Group A: Arm 1Experimental treatment 1 intervention
Group B: Arm 2Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Determine if the combination of enzalutamide and PDS01ADC is associated with an increase in the duration of PSA suppression compared to that of enzalutamide alone

Kaplan-Meier curves and a one-tailed log-rank test. The median time to loss of PSA control on each arm will be reported along with a 95% confidence interval; in addition, based on the result from the prior trial, the probability of PSA control at 224 days (approximately 7 months) will also be reported on both arms, along with 95% confidence intervals

Time frame
5 years

Secondary outcomes

1

PET changes after enzalutamide with and without PDS01ADC treatment

PET changes will be reported descriptively

Time frame
1 year
2

Safety of study treatment

Safety will be evaluated by determining the frequency of adverse events among treated participants and reporting the results, by maximum grade of event and type of toxicity noted

Time frame
until 30 days after last dose of study drug
3

Evaluate immune response

Results of peripheral immune cell subsets including CD4 and CD8 T cells, NK cells, Tregs, and MDSCs measurements will be reported descriptively

Time frame
1 year
4

PSA detection

The proportion of participants with undetectable PSA at 12 months will be reported along with a 95% confidence interval

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cancer Institute (NCI)

Lead sponsor

Source ClinicalTrials.gov
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